Imetelchat - Geron Corporation (GERN) stock forum & discussion – Yahoo ….

Excerpts from NCI---for review Off-label drug use refers to the practice of prescribing a drug for a different purpose than what the FDA approved. I wouldn't consider settling a lawsuit - "defending" - one by any means. Wish they could be here to help us celebrate. But during the actual meeting, the stock will be halted. Geron has Imetelstat with excellent phase 3 trials, a good safety record, disease modification, transfusion improvements, much better survival time, observed CRs and PRs, and unmet patients' needs. InvestorPlace - Stock Market News, Stock Advice & Trading Tips By buying these best growth stocks of companies exploiting huge, ongoing trends InvestorPlace - Stock Market N. info Board index ImetelChat; Search; More Ash 2022 - check out at 6 min 25 sec. Has anyone seen any comments besides the X comments kindly referenced by RC? Usually there is a bunch of video interviews, articles post ASH. Did not see a mention of NEA though. Abbvie's CEO Richard Gonzalez is being replaced come summer of this year. Find the latest Geron Corporation (GERN) stock discussion in Yahoo Finance's forum. We are all waiting for the formal approval of Imetelstat. Belén Castillo - Clinical Trial Liaison at The Medical Affairs Company (TMAC) for Geron Corporation Barcelona, Spain Aug 2020 - Present 2 yrs 4 mos. Wow, when somebody writes "my life depends on it", it gives you pause and makes you realize the gravity of this decision. Unnecessary disease in those that did not benefit. but Imetelstat treatment approaches and outcomes that vary significantly. 2015 ram 2500 perform service reset It excels in overall survival time, disease modification, safety profile, transfusion independence, and maintaining the quality of life. And have read the words of some awesome writers. It’s been a year since one of the world’s bigg. Go over to Imetelchat and read Kmall's 6 part series, "Go Big Or Go Home" for a detailed breakdown of patient in-discrepancies and market potential with actual links provided of data compiled. Short bones in the human body are often cube-like, their length, width, a. Stocks are always halted the day of the advisory committee meeting. 8M from cash exercises of warrants and may. Geron and MAIA are working on cancers, but at the opposite end of the spectrum (blood cancers and single-agents vs. Another way of saying this would be: The data is remarkable (robust and compelling), the NDA is completed and under review, fast-track approvals are assured, and patients' needs have never been greater. by LWS » Wed Feb 22, 2023 4:26 am. Microsoft's popular Windows Live SkyDrive file storage service in the cloud is now available for iOS, allowing users to easily access files in their SkyDrive directly from their iD. More important will be the Vote question. by CKTC » Fri Mar 15, 2024 12:55 pm. HEARING IS SCHEDULED IN FRONT OF THE HONORABLE WILLIAM H. Geron Announces Publication in The Lancet of Results from the IMerge Phase 3 Clinical Trial Evaluating Imetelstat in Lower Risk MDS • Business. Re: Everyone catch this one last night? by LWS » Mon Feb 12, 2024 4:12 pm. I suspect the article referred to the recent AML/feroptosis work from Dr. MA should be highly likely bolstered by virtually every expert we have heard who makes a point of emphasizing that the grade 3. This section provides you with an archive of past and present …. Adding to the discussion of Dr. Patent expiration is looming with several key established drugs in their pipeline. , January 18, 2024-- (BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today reported that it has granted non-statutory stock options to purchase an aggregate of 895,930 shares of …. All price increases are immediately swatted down. Jas Khera, Managing Director of WEP, said: "We are proud to be working with Geron on this EAP. 26, 2024) There were no Hy's Law cases. Nice, ‘#MDS Gurus from around the world’ pretty much says it all (Quoted the wrong tweet, it was Dr. Geron was betting the farm on imetelstat’s successful challenge to JAK2 inhibitors in the myelofibrosis space. A new drug application (NDA) for imetelstat, a telomerase inhibitor used to treat transfusion-dependent anemia in patients with low- to intermediate-1–risk myelodysplastic syndromes (MDS), has been submitted to the FDA, according to a recent press release from Geron Corporation. we are close to finally, finally proving, and being validated as, a life saving drug: Comment. Scarlett said they wouldn't be "pinching pennies" to bring Imetelstat to market, he certainly wasn't kidding around. Update for TMAC recruitment of P3 IMpact in Europe 1/27/2023: Italy-Arcispedale S Maria Nuova, AO di Reggio Emilia - Reggio Calabria, Italy, 42123 - Now Recruiting. Ignore the noise, only truthful testimonials like this are important now. MAIA or Geron’s as yet to be revealed, oral agent in early development) could hold promise. Inside the pouch is a metal disk that crystallizes the liquid causing it to heat up. Re: Request for Imetelchat Board thoughts. The bigger question, if you will, might be why we haven't had a first patient dosed in this study as of now since the TELOMERE Clinical Trial is on an FDA "hold" until an "appropriate dose for single agent …. Recipient: Administrator Your email address: Your name: Subject: Message body: This message will be sent as plain text, do not include any HTML or BBCode. You can expect to see a few Discussion Questions, which will be the focus of the ADCOM meeting. For more information, visit www. Yes Jay, it seems that we have a long and fluid catalogue of board members with experience in buy outs. No negative news at all for the ADCOMs to consider. by kmall » Fri Jan 20, 2023 10:02 am. MAIA, after Geron, will be the #1 beneficiary of Imetelstat's NDA approval (from ODAC & FDA). through an online teleconferencing and/or video conferencing platform. Luspatercept , as CKTC has pointed out is in the "sweet spot" but pretty soon three questions will be asked of Imetelstat: 1. I've not once felt that biopearl or kmall have echo-chambered this educational message board to pump Geron or imetelstat. More specifically; a combination of a telomerase inhibitor and a Bcl-2 inhibitor are useful in treating hematological cancers, including AML. OVERVIEW The full value proposition associated with the IMproveMF Phase 1 trial isn’t being properly recognized by the investment community. And Geron should, or another company will. Comments made to the effect that Imetelstat is in a “different space” and the goal is to prolong life and improve the bone marrow picture. We are committed to creating broader treatment access solutions, and. I guess we’ll be waiting until the last possible day to hear about the status of the NDA. Aug 27, 2023 · Open Public Hearings (FDA) Thanks bp--- It appears that we will have ample opportunity to interact with the FDA concerning their obligation to approve the NDA for patients' unmet blood cancer needs in a timely way. 5 million, while general and administrative. The drug must demonstrate, through clinical trial data or other scientifically valid information, the potential to provide a significant improvement in safety or effectiveness over existing treatments. Apr 11, 2024 · by Ryan » Thu Apr 11, 2024 6:17 am. Re: A blessing from the hepatologists Major hat tip to Wildrides YMB. Together, we continue to advocate for progress and hold onto the belief that …. BY ALICE PARK DECEMBER 13, 2022 9:46 AM EST Coming off the success of its mRNA vaccine for COVID-19, Moderna announced on Dec. by rccola335 » Wed Jan 17, 2024 3:52 pm. In the crosshairs of Geron's development plan was the myelofibrosis market dominated by Incyte's JAK-2 inhibitor, Jakafi. The concept of a telomerase inhibitor, as an important treatment for most cancers, will have been established in 2024 as a critical breakthrough for the treatment of most. No shit, you have quite a talent beyond your normal jobs, if those jobs are many. You did an excellent job representing Geron patients, employees, and investors alike. I guess it's safe to say around 100 million shares will trade Friday. NO ONE can find an ODAC (Oncology Data Advisory Committee) positive recommendation (March 14th) that has ever been rejected by the FDA. Two units every 7-10 days, that’s difficult. sharing some of the things on twitter about imetelstat from the ASH meeting. Bp - Correct, however, pre-market it had traded just under 25million shares, and was up substantially intra-day, like 30-40%. The board administrator may also grant additional permissions to registered users. On the Imetelchat front, I would have thought this would be high on the radar, being it’s 10 years in the making to the clinic, not to mention that the patient population is by far the highest among the current diseases being treated in the clinic. 1 Imetelstat is used to treat patients who are …. 7 Billion since 1997, specific to telomerase drug development, give or take $300 Million. Luspatercept, does that mean that Imetelstat …. I do wish they would share experiences of being in the study even if on placebo. The Applicant is seeking approval of imetelstat (proposed trade name RYTELO) for the treatment of. THRSF: Get the latest Thunderbird Resorts stock price and detailed information including THRSF news, historical charts and realtime prices. I would add the list one more question. A textbook example of how to anticipate, prepare, and deliver under …. Notice this is not Geron PR involved in this press, articles and news clips, in Australia. by Ryan » Tue Mar 19, 2024 2:50 pm. --(BUSINESS WIRE)-- Geron Corporation (Nasdaq: GERN) today reported that it has granted non-statutory stock options to purchase an aggregate of 189,850 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company. Rizo will keep her unvested stock options going forward. In total there are 23 users online :: 0 registered, 0 hidden and 23 guests (based on users active over the past 5 minutes) Most users. The goal now is to get ODAC moving, speaking to the FDA, and approval of Imetelstat's NDA. by kmall » Thu Jan 11, 2024 12:45 pm. , June 29, 2023-- (BUSINESS WIRE) --Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for imetelstat, the Company's first-in-class telomerase inhibitor. It's pretty obvious that the extraordinary manipulation we have seen, not only recently but over the years is in play on some level. Patience is thin, is the understatement of the century. Monitoring the health of one's heart and cardiovascular system is one of the most important preventative steps an individual can take to ensure their long-term health. info Board index ImetelChat; Search; Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat. This company has a fast track and orphan status designation in the US and in Europe. Nice piece of info and I align with the call. Rizo, it's COMPLETELY apparent that Dr. This appears to be true: 1/ Telomerase inhibition is an important factor is treating most cancers, and in combinations has the potential for cures. And to all who have contributed to making this board worthwhile. A textbook example of how to anticipate, prepare, and deliver under extreme. Discover the best graphic design consultant in Washington DC. by jayfish101 » Thu Mar 14, 2024 10:41 pm. Probably should submit to Merriam-Webster for new word of the year. Last edited by rccola335 on Sun Dec 10, 2023 8:57 pm, edited 1 time in total. I think we'll see an early readout on the Investigator led IMPress HR-MDS/AML trial before we hear anything on Imet 2. Sergei Gryaznov, now at MAIA)) spent so much time with both companies developing Imetelstat and THIO as important cancer medicines. I'll call back the mentions in each of the previous two quarterly calls that Dr. In particular, in a partnership business, all partners share liabilities and profits equally, while in others, partners may have limited liability. However, all agreed that transfusion independence was an important goal. “Having this extra weapon in our arsenal would create so much opportunity particularly in combining this drug, and others like it, with existing treatments like chemotherapy and other novel cancer therapies," Professor Lane said. While small molecule candidates will probably account for around 50% of the deals, Cantor says. provided notice in the Federal Register that it has scheduled an advisory committee meeting of the Oncologic Drugs Advisory Committee as part of …. Geron says the agency also plans to hold an advisory. Looking at Geron's most recent earnings report, as of June 30, 2023, the company had $400. MAIA (THIO) and Geron (Imetelstat) are covering most of the telomerase cancer ongoing opportunities from liqiud to solid. Whatever the truth behind the JnJ discontinuation, the facts and data support that they must surely still have some level of interest in Imetelstat, which is proving to be much more promising, impactful and lucrative than they originally thought back then. antique decoys for sale The science just changed, we didn't understand telomere replication. 6 days ago · Welcome to the website for the Geron Securities Litigation. Bridge, thanks for trying to contact me re new Geron patent filing. ODAC has recommended Imetelstat (March 14th) and the FDA always accepts overwhelmingly positive votes (12 YES votes from blood cancer oncologists, 2 NO votes from others). The CE Shop specializes in online real estate education. Imetelstat---It all seems to be tied together in one important cancer treatment package, that may lead to cancer cures (TBD by many years of research) --- transfusion independence, disease modification, telomerase, telomeres, ferroptosis, feeling better (fatigue, quality of life, etc. CKTC found 2 cases (ODAC recommended, FDA. The development of imetelstat is grounded on Nobel Prize-winning scientific discoveries by early Geron collaborators that expanded the understanding of telomeres and telomerase and their role in the proliferation of cancer cells. 5 days ago · ODAC recommends (12 YES votes from blood cancer experts, 2 No votes) and the FDA approves. roms megathread Acceptance and approval of the Imetelstat NDA is the focus by patients, caregivers and investors. When a person dies, all of his affairs must be settled through an orderly legal process. by biopearl123 » Mon Mar 18, 2024 1:13 am. If my recollection serves, it was around the time of the NEJM Tefferi article. The first patient (1/45) was dosed in June and the trial was ~50% enrolled a couple months ago, and the recent Dr. THE COURT APPROVED THE CASE DURING THE SETTLEMENT FAIRNESS HEARING ON AUGUST 24, 2023. Feller 1/Imetelstat (for ET) was completely successful with CRs and Cures (all completed by Geron), but that was not sufficiently financially feasible then (at Geron with Dr. by biopearl123 » Fri Apr 12, 2024 1:06 am » in ImetelChat. It basically means they get down to business. by Ryan » Mon Feb 26, 2024 10:44 pm. I think the subtext is that there is hope that progression to high risk and AML may be attenuated (and if so. And of course to John and his team who had the vision to see this through to this point. ImetelChat message board Home Pre-clinical Clinical Commercial Events Contact Your suggestions are welcome! Please feel free to send suggestions for content or otherwise. HI & Bp - was able to pull up two topics of interest with regards to the possible EMA "supply chain" question posed by Hoosier, although neither one seems overly pertinent to Geron's current situation focusing on pre-Regulatory submissions. (RTTNews) - The Canadian market ended modestly higher on Wednesday, led by gains in energy and materials sectors. by earfool » Thu Mar 14, 2024 9:09 pm. It's eye-opening to say the least. S that when the malignant clone which has spawned many many daughter cells that the bone marrow is filled these abnormal cells, bad things happen. shared voting power 24,443,571 7. They decide on priority review (a given with unmet needs and great clinical data) so they will …. Chemotherapy drugs, such as fludarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Geron Corporation (NASDAQ: GERN) is a clinical-stage biopharmaceutical company focused on the development of its sole candidate, imetelstat, for the treatment of hematologic malignancies. Doing so may lead to you being immediately and permanently banned, with notification of your Internet Service Provider if deemed required by us. Groundhog Day 2024: Punxsutawney Phil did not see shadow, predicts early spring. My comments were based only on not seeing any statement in the FDA material that an additional study was warranted. The real challenge for Geron with the FDA has been going on behind closed doors, and that's the wording of imetelstat's labeling. With the assumption that there is no fraud, and considering what appears to be overwhelming good news about Imetelstat (trials, KOLs, conferences, publications, etc. info Board index ImetelChat; Search; More stuff. They've been direct and forthcoming, and …. Someone asked about the 4 years of TI and I was unable to respond - I believe Dr Faye Feller said they just dosed a patient for their 4th year of TI and also Dr Valeria Santini said she had a patient approaching 4 …. jlg fault codes list Feb 5, 2024 · Review Material: SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded. In the meantime a buyout/partnership conceivably could occur. A first-in-class investigational drug with the potential to extend and enhance lives. by LWS » Thu Mar 14, 2024 8:46 pm. With all of the handcuffs placed on docs these days (read “you need prior authorization for that”) the fight to let doctors be doctors is valid and valuable. They all serve different purposes like enabling the animal to survive in seawater below freezing point at the South Pole. The company's New Drug Application (NDA) for Imetelstat, specifically for. Geron Corporation (NASDAQ: GERN) is diligently progressing towards the regulatory milestones for Imetelstat, its potential therapeutic for hematologic myeloid malignancies, particularly targeting myelodysplastic syndromes (MDS). Lekola, that program is very early and I suspect now Geron will slow roll it and keep the focus on approval for IV Imetelstat. 149 COMMONWEALTH DRIVE SUITE 2070 MENLO PARK CA 94025 UNITED STATES. Scarlett and Geron announced 3 new Clinical Programs (IMproveMF, IMpress, and TELOMERE) and one new Pre-Clinical Program to “explore the use of Imetelstat as a single agent and in combination with current standard of care treatments to expand the potential application of Imetelstat. oak chairs for sale near me review, to be held virtually on March 14, 2024, from 9:30 a. Welcome to the website for the Geron Securities Litigation. In the crosshairs of Geron’s development plan was the myelofibrosis market dominated by Incyte’s JAK-2 inhibitor, Jakafi. Imetelstat kills cancer stem-cells in 2 ways and is needed now by suffering patients. How retirement investors can assess the costs of their funds and benefit by choosing the lowest-cost options. php?f=1&t=690#p1818 FDA Thoughts on Accelerated Approval Wed Jul 18, 2018 7:34 pm. He is smiling because he knows two prominent things (among the many). As a user you agree to any information you have entered to being stored in a database. 0835 ET - Geron says the FDA didn't grant is request for a priority review of imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes and instead assigned a standard review and target action date of June 16, 2024. RA Capital headlines, assume they took 9. AML is now in focus as the next step beyond ET, MDS and MF. The biggest negative is likely the $0. Dylan Supina - Sr Director, Real World Evidence Analytics & Strategy - 2023. bp, Ryan --- The count is now 10 (ODAC Imetelstat meeting, March 14th) Most on this board follow the science, publications, conferences and medical successes of Imetelstat (earth 1), that judge Imetelstat to be a much needed and deeply researched blood cancer medicine. They have already taken an important step in that direction, with the EAP (Extended Access Program). by biopearl123 » Wed Dec 06, 2023 4:02 pm. by jayfish101 » Thu Feb 22, 2024 10:37 pm. Geron Announces Fifty Percent Enrollment in the Phase 3 IMpactMF Clinical Trial Evaluating Imetelstat in Patients with Relapsed/Refractory Myelofibrosis • Business Wire • 12/06/2023 01:00:00 PM. The trials (with minimal safety concerns) have shown positive results in transfusion independence, survival time, disease modification, and. Hmmm somebody has made 2 large over 4000 calls 1 week apart of the Jan 2025 calls now for a total over 9000Insider info ??. In combinations (research for many years to. Living within your means should be the first step on your journey to financial freedom. I will try to post my thoughts & observations prior to the upcoming Q4 & 2022. It was incredibly heartening and after the first session of “Judge Jury and Executioner” as it seemed to me, I (and everyone including Dr Feller who made sure to make public comment / note to thank the patients who were …. I have renewed hope that Geron and the FDA can work this out post-haste. That would be wonderful news & opportunity for us. I think most on this board would find it well worth watching. The SAVERS acronymn reminds us of six habits or rituals that can improve our morning routines. It's very slow moving in case you haven't noticed. Importantly, 61 of these are currently in the regulatory phase, pending decisions from the FDA. 1/ Ferroptosis (Inflammation in a variety of diseases) 2/ Telomerase & Telomeres. As previously disclosed, in August 2023, Geron Corporation (“Geron” or the “Company”) announced that its New Drug Application (“NDA”) for the. Forum rules - Comments must be civil and on topic - Back up claims with evidence/reasoning/sources (posting links is allowed). Re: "Next Generation TI Program". As you can see on clin trials site, there have been many solid tumor studies from over a decade ago that failed. It’s not a long read and has several striking quotes. Unless the 'sky falls down', Imetelstat is soon to be recommended by ODAC, and approved by the FDA. ImetelChat message board Home Pre-clinical Clinical Commercial Events Contact Pre-clinical research There exists a history of preclinical research on telomerase and imetelstat, ignited after the discovery of telomerase by Carol Greider and Elisabeth Blackburn in 1984. Let's start with the side effects of blood transfusions: 1. Nov 14, 2023 · Today the EMA Approves Modification to Imetelstat PIP. Investment and Insurance Products …. Looks like they are back on board. by biopearl123 » Sun Jan 07, 2024 6:12 pm. Jul 5, 2020 · Geron Announces Fifty Percent Enrollment in the Phase 3 IMpactMF Clinical Trial Evaluating Imetelstat in Patients with Relapsed/Refractory Myelofibrosis • Business Wire • 12/06/2023 01:00:00 PM. Housing estates, new highways, and a golf course sit next to one of Africa's largest slums. made an individual purchase of 170,940 shares of the …. The PPS will soon be in double digits. Abstracts public about a month before. Speaker #3 was a patient from TX, who said she was ready to meet the Lord upon hearing her treatments were not working. Are you curious about compound interest? Learn how it works in relation to investments. Scarlett has traditionally used the expression, "watch this space" and I always took that to mean, 'watch what we do, not …. calhoun ga craigslist Imetelstat, a first-in-class telomerase inhibitor, demonstrated meaningful clinical benefit including a robust symptom response rate and potential overall survival benefit in IMbark, a phase II study in intermediate-2 or high-risk myelofibrosis (MF) patients who have relapsed after or are refractory to JAK inhibitors. Imetelstat should be in great demand as a proven blood cancer medicine that is needed now (patients, investors, KOLs, potential partners) across the board. Remember, this drug has orphan drug designation and is already approved for a rolling submission. For example, in its presentations, Geron always uses the 2018 revised IWG criteria for HI-E response which in the trial was statistically significant in favor of imetelstat vs placebo. Helping you find the best gutter guard companies for the job. Even if red flags are raised it's easy to simply disappear. Luke Lango Issues Dire Warning A $15. Form 8-K - Current report • Edgar (US Regulatory) • 12/15/2023 09:23:51 PM. by jayfish101 » Mon Mar 11, 2024 10:10 pm. However, I have little doubt that while we wait for marketing authorization, and perhaps even as Revenue begins, our ‘wait’ as investors will involve days and weeks of “max pain”. Imetelstat, a first-in-class telomerase inhibitor, demonstrated meaningful clinical benefit including a robust symptom response rate and potential overall survival …. Imetelstat is a first-in class telomerase inhibitor for the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS). info Board index ImetelChat; Search; Post to Fish Jr. I can somewhat understand the attack dog mentality of the FDA rep as Imetelstat is a first in class novel drug never before approved for any indication. Fish Jr, Biopearl, kmall, and every member who has lent their voice to our community, your contributions have not gone unnoticed. Filed after the "to be made public deadline, but will be still considered by ODAC" was a filing from " Institute for Clinical and Economic Review". The fact that the FDA has already allowed continued access to Imetelstat beyond the actual study was the basis for that comment. Mayo’s “tantamount to a cure” language is misleading and largely incorrect. WEP's management consists of Ex-Big Pharma and Healthcare employees who's former employers include: Sanofi, AstraZeneca, MSD (Merck), Pfizer, Novartis, Alcon, SunGuard, Northgate and Capita. I’m seeing new underwriters in TD Cowen and Barclays. When it happens, Imetelstat becomes a factor in all telomere/telomerase …. Probably looking at a five year timeline (at least) for development and moving through all phases of required study. The name and details of the European partner have the potential to move the price significantly - I think the FDA and European approvals are. Check out the following five most popular ins. Let's hope we all " ride into the sunset" soon as he mentioned. Namebackwards could've been writing on Twitter and imetelchat from a local library or somewhere else with a common IP address. 3 million shares were bought - that is a lot of after hours buying. I like this one: " Imminenter". They've taken an offensive big step in securing a global presence in the space. The discussion has come down to the scheduling of the Oncology ADCOM meeting featuring Imetelstat and John Scarlett's views on the business going forward ("Imetelstat is bigger than all of us"). I believe they are focusing on a combination for non-small-cell lung cancer with Regeneron. Oct 16, 2023 · Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Re: “Next Generation TI Program“. January 19, 2021 - Imetelstat exhibited dose-dependent inhibition of the telomerase target, as evaluated by reductions in telomerase activity, human reverse transcriptase levels, and telomere. Imetelstat is not the "perfect" blood cancer medicine, but it is "very good" in many situations and is needed now by patients and it is unique. Bloomberg Philanthropies has honored nine cities for using data to improve their residents' lives, and Los Angeles tops the list. Other salient feature, Grade 3-4 neutropenia in 68 % (manageable and transient) but notably only 1% with febrile neutropenia. by Bigfun » Wed Mar 27, 2024 8:16 pm. RC either we are missing something or the FDA is. by CKTC » Wed Mar 13, 2024 5:03 pm. 1546 Topics 6751 Posts Last post payout by jayfish101 View the latest post Tue Apr 16, 2024 4:23 pm Login • Register Username: Password: I forgot my password. Jun 2015 - Jun 2019 4 yrs 1 mo. eu is to provide easy access to existing information about imetelstat , its basic workings, clinical potential and results from preclinical and clinical studies. Giving imetelstat in combination with fludarabine and cytarabine may work better in treating patients with refractory or …. Labor Day celebrates hard work and a job well done. It covered 2 of the indications Imetelstat was currently targeting in its latest Phase 3 Clinical Trials: IMerge - MDS (Myelodysplastic Syndrome) and IMpact – MF (Myelofibrosis), as well as AML (Acute myeloid leukemia); which for all intents and …. Hy’s Law criteria were not met because both patients had more likely alternative causes for the. This will provide a forum for not only a transparent review of the data, but an opportunity to hear from, well, just about anyone. Jump to When it comes to artificial intelligenc. Share your opinion and gain insight from other stock traders and investors. Feller was an easy choice to replace Dr. Negotiated multi-million dollar settlements representing the U. TJ McLaughlin - Sr Director, Global Pricing and Contracting - 2023. * To help inform & support the retail shareholders of Geron, I will post my thoughts (here in Imetelchat) on the following topics. My thought is that the data is convincing and the EAP (JS said---could be considered a phase 4) is ongoing. You agree that “ImetelChat” have the right to remove, edit, move or close any topic at any time should we see fit. Someone is trying to wear a drenched raincoat onto the trading floor on a sunny day. That seems to have everyone on edge, along with the PPS under $3. I do expect some significant collaborations or partnerships to accelerate the manufacturing, distribution and sales of Imetelstat. between 4:40 and 5:30 more than 3. Please note that the YouTube live video of the meeting will not broadcast until …. Reblozyl as far as the data up to this point indicates, as well as Imetelstat's potential for commercial market share once approved. Nonetheless less, new combinations might be tried or new ways up inhibit telomerase (e. Geron aims for FDA approval of imetelstat in June 2024 for hematologic malignancies, targeting an H1 2024 launch. Patient #9 was put on Luspatercept in Jun'22. As of now until we see something trustworthy, ADCOM will probably be in April with anticipated. by biopearl123 » Tue Feb 27, 2024 9:00 pm. Fireside chats, ASH2023, ODAC Stifel 2023 Healthcare Conference Tuesday, November 14th at 9:10 a. Financials stocks drifted lower (RTTNews) - The Canadian marke. There are several types of partnership arrangements. It did cross my mind that the delay here could be tied to an early approval on AML since it's mentioned with MDS by both Regulatory Agencies. Well, hence the cytopenias that are "limited and manageable. It's a good time to reflect and give THANKS to all of those Clinical Trial patients; past, present and future, who have courageously sacrificed to propel Imetelstat to the brink of approval. by biopearl123 » Sun Aug 27, 2023 10:31 pm. The FDA, other biotechs, Big Pharma, medical and scientific advancements all fall under that umbrella. Cancer Delivery Systems and Artificial Intelligence. At the moment, there seems to be an effort to keep the price under $2. BENEFIT: * A patient who realizes a meaningful improvement in their A) transfusion frequency, B) transfusion …. Kmall, I was amazed at your numbers from several years ago, thinking them perhaps too optimistic. Points made: that Lus doesn’t seem to promote the malignant clone was viewed as good news. , December 21, 2023--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today reported that it has granted non-statutory stock options to purchase an aggregate of 417,490 shares of Geron common stock as inducements to newly hired employees in …. ASCO is usually May/June and EHA is June 13th. Username: Password: I forgot my password. Search in forums: Select the forum or forums you wish to search in. Partnerships: A formal arrangement by two or more parties to manage and operate a business and share its profits. Lisa Meletta - VP, Associate General Counsel, Chief Compliance Officer, Geron Corporation. Brenner foresees the day when early disease can be detected and wiped out with an agent that actually attacks the malignant clone early. The End Game: The NDA has been summitted to the FDA, with all (i's) dotted and (t's) crossed. I may be naive but I view the upcoming ADCOM meeting as a positive (the market doesn't seem to). Groundhog Day 2024: Punxsutawney Phil did not see shadow. by CKTC » Sun Jun 21, 2020 11:07 pm. Perhaps it could be used in true combination, sequentially, or afterwards to help minimize the cancer developing a resistance to the primary chemo treatment. March 14, 2024 Meeting of the Oncologic Drugs Advisory Committee (ODAC) Webcast Information The Center for Drug Evaluation and Research (CDER) plans to hold the March 14, 2024, meeting of the Oncologic Drugs Advisory Committee virtually via YouTube platform. by lacour_98 » Thu Jan 18, 2024 11:28 pm. KT --- Imetelchat is a chatroom. Cushing's Syndrome (Hypercortisolism) is a rare hormonal disorder caused by over exposure to the hormone, Cortisol. by LWS » Wed Sep 20, 2023 12:41 am. Go over to Imetelchat and read Kmall's 6 part series, "Go Big Or Go Home" for a detailed breakdown of patient in …. I believe there are valuable nuggets & considerations within each topic that are not reflected in today's awareness and/or stock price. Mar 1, 2024 · Luspatercept , as CKTC has pointed out is in the “sweet spot” but pretty soon three questions will be asked of Imetelstat: 1. Note: One of the most important features of Imetelstat is the very positive "fatigue-factor" --- that is this medicine can make you feel better and improve the quality of life (enjoy life). Last post by huntingonthebluffs. Ryan and Gwik - Indeed ferroptosis is a HUGE deal, and abstract 201 from last year's ASH stood out for that very reason. GERN has a market cap of $334mn and a cash reserve of $215mn. hca hr answers benefits The IP address of all posts are recorded to aid in enforcing these conditions. You can take this medically-reviewed depression quiz to help determine whether you have symptoms of depression and if you should speak with a mental health professional. conjugates, radiopharmaceuticals and T-cell engagers as being particularly attractive acquisition. I too have seen the March date mentioned but only by completely unreliable sources. There are many fans who read the Geron Imetelchat board which was started by a patient with MF who could not avail himself of Imetelstat treatment and subsequently died. Re: This is a big deal- a convert. Kenya, the largest economy in East Africa, has some of the starkest inequality in the re. by Hoosier Investor » Tue Mar 12, 2024 6:02 pm. There has been considerable discussions (some on this board) about Imetelstat and cancer vaccines. #1 take away (beyond transfusion independence) --- "Dynamic Increase of Hemoglobin". Joined: Fri Jul 20, 2018 5:13 pm. u haul rental 29 palms Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Disease modification again mentioned. Geron (NASDAQ:GERN) is a Nasdaq-listed biotech that has been around a long time - its IPO took place in 1996 at $8 per share, although the. This is a follow-up with additional thoughts. Of course we are anxious: We all believe that the FDA will accept and approve Imetelstat, especially with the EAP in place to cover any time gap between now and approval. by biopearl123 » Wed Mar 06, 2024 10:08 pm. 3 days ago · Ryan, you are always teaching me new words. Are you aware of any agent in development or in the clinic that has shown conclusive disease modification in this condition. Just the newer classification system that up’s more patients out of lower risk categories and highlights that there is utility in more advanced classifications going forward. This preparation was clear, but it was also clear to me and assume. For some unknown reason they walked. Two patients had both post baseline elevated bilirubin > 2 x ULN and ALT≥ 3 x ULN, i. BP's getting roughed-up and making significant changes in leadership--and profitability outlook--quite early on this year. by lacour_98 » Wed Apr 17, 2024 6:44 pm » in ImetelChat. I have a theory as to why the FDA came out swinging so hard on the efficacy issue when it should seem obvious to most that the drug works. Your resilience, compassion, and commitment to supporting one another are truly inspiring. BP et al I submitted two (2) specific questions regarding the Ex-US licensing outcome 1) Should we expect a materially significant upfront milestone payment(s) associated with licensing the ex-US rights?. Mar 27, 2024 · Re: Take me to your leader. The FDA has a built-in argument against exposing these patients to imetelstat’s side effects without evidence of benefit. I’ll call back the mentions in each of the previous two quarterly calls that Dr. By clicking "TRY IT", I agree to receive newsletters and promotions fr. He is now getting people to read who had never. snake costume amazon by rccola335 » Fri Mar 15, 2024 2:24 pm. ODAC recommends (12 YES votes from blood cancer experts, 2 No votes) and the FDA approves. I don't have any further details other than the link I provided in the 3rd post of this topic chain which opens the official EMA document which sanctions and approves the investigatory use of Imetelstat in children between the ages of 28 days and 18 years with MDS, JMML, and AML. Re: There are many ways to think about partnering. El idioma oficial del PatientPortal es el inglés. by Commsman » Tue Nov 14, 2023 2:52 am. by CKTC » Sat Mar 09, 2024 7:03 pm. While I do agree that Imetelchat isn't necessarily the board to discuss the SP and any potential manipulation of the SP, it does and has presented itself here from time to time. Nineteen panel members also received a total of $1. 1 Replies 265 Views Last post by LWS Wed Apr 17, 2024 7:43 pm RYTELO « by huntingonthebluffs » Sat Apr 06, 2024 8:34 pm » in ImetelChat. Speaker #4 is Dr / expert from Cornell, non-sponsored who had consulted with Geron in the past "Enthusiastic to have Imetelstat as a treatment option. And comparing the dance around CAR-T therapy’s issues compared to Dr. We describe the rationale and design for the phase III trial, IMpactMF. Luspatercept , as CKTC has pointed out is in the “sweet spot” but pretty soon three questions will be asked of Imetelstat: 1. Previous for reference: Imetelstat is a miracle blood cancer medicine that uniquely modifies that group of diseases, kills cancer stem cells (in 2 ways), brings about transfusion independence, and will effectively treat (PRs, CRs, possible cures) some cancers in combinations. I was a little surprised with the timing of the article given the upcoming ASH conference and some of ASH's restrictions and embargos. When it happens, Imetelstat becomes a factor in all telomere/telomerase (about 90. Mar 1, 2024 · Namebackwards could've been writing on Twitter and imetelchat from a local library or somewhere else with a common IP address. The NDA has been summitted, and soon will be accepted and approved. Then off-label uses can be explored including new combinations. In Q2 2023, Geron received $17. The FDA rep was intelligent and very data literate…. ODAC has spoken and the FDA always accepts their positive, overwhelmingly good recommendations (12 yes including blood cancer experts, 2 no ). ImetelChat is a forum where investors can discuss the latest news and developments of Geron Corporation, a biotechnology company focused on stem cell …. Furthermore, it's in a separate phase 3 which should produce interim data in early 2024. Sometimes there will be pre-market and post-market trading. Just today, Nov 13, 2023, the European Medicines Agency approved a modification to the Imetelstat Paediatric Investigation Plan to allow imetelstat to be administered to children between the ages of 28 days and 18 years with MDS, JMML, or AML. Here’s the relevant quote from Dr. Thanks for posting Jayfish, considering we have heard plenty from KOLs already, virtually all of which has been positive, I think an ADCOM is a positive event and will give voice to patient advocates, patients and physicians. In total there are 23 users online :: 0 registered, 0 hidden and 23 guests (based on users active over the past 5 minutes) Most users ever online was 379 on Thu Jul 29, 2021 4:50 am. Indices Commodities Currencies Stocks. Imetelstat is an inch from being an approved medicine by the FDA and others. Dec 2, 2023 · Imetelstat---It all seems to be tied together in one important cancer treatment package, that may lead to cancer cures (TBD by many years of research) --- transfusion independence, disease modification, telomerase, telomeres, ferroptosis, feeling better (fatigue, quality of life, etc. I think we have to remember how COVID dreadfully set back enrollment in many studies. Pfizer (NYSE:PFE) ran its first Super Bowl ad on Sunday, highlighting its efforts in oncology as the COVID-19 vaccine maker looks for post-pandemic growth following its recent acquisition of cancer drug maker Seagen (SGEN). Geron aims for FDA approval of imetelstat in June 2024 for hematologic malignancies, targeting an H1 2024 …. The LA-based venture firm that Brendan Wallace and Brad Greiwe launched less than seven years ago already has $3. The name and details of the European partner have the potential to move the price significantly - I think the FDA and European …. vr kanojo 2 From Imetechat - "Go Big Or Go Home - Pt. Iron studies, platelets, and white blood cell counts have been within. The FDA notes that the p-value of HI-E, according to the 2006 guidelines, is p=0. Comments after that date will be taken into consideration by the FDA. , (NYSE American: MAIA) (“MAIA,” the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that independent director Mr. CKTC’s theory about why the FDA came out with guns blazing is interesting. Re: Finally, disease modification? by Ryan » Mon Mar 11, 2024 7:54 pm. Once the Event Materials are posted, hopefully, today, the two PDF files everyone will want to look at are: • FDA Briefing Document. RISK: * A patient who experiences a Grade 3/4 event WITHOUT realizing an improvement in their A) transfusion frequency, B) transfusion burden, or C) Hemoglobin levels. Combos with Imetelstat will take this to a whole other level. model mayhem atlanta discuss new drug application (NDA) 217779 for imetelstat for injection, submitted by Geron. I'm seeing new underwriters in TD Cowen and Barclays. 2 billion in assets under management. 1549 Topics 6760 Posts Last post Re: PPS by LWS View the latest post Sat Apr 20, 2024 4:03 pm Login • Register Username: Password: I forgot my password. Well, hence the cytopenias that are “limited and manageable. Jan 10, 2024 · Imetelstat is a first-in class telomerase inhibitor for the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS). LWS, I have to strongly disagree with you. Material for ODAC (Oncology ADCOM) Imetelstat is listed as one of the "Top 10 Most Anticipated Drug Launches Of 2024" Release date：2024/1/9 14:13:59. Nov 24, 2022 · Belén Castillo - Clinical Trial Liaison at The Medical Affairs Company (TMAC) for Geron Corporation Barcelona, Spain Aug 2020 - Present 2 yrs 4 mos. estes express jobs near me Hi Saltrock and thanks for posting. While a fairly sizeable amount, it pales in comparison to the approx $200M/yr current burn rate. QT interval disorders and specifically "Torsades de Pointes" are of particular interest to EPs. Advertisement These heat pads are. pearson funeral home emporia virginia , June 29, 2023--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for. Thanks for the video link rccola3365! I thought this was one of the better interviews JS has ever given. by LWS » Wed Jan 31, 2024 7:15 pm. ), living longer, minimal side effects, combinations. AML study PII results will probably not be known until a scientific meeting. I don't see any problem for 6-thio-dG, but would like to hear any ideas on it. Imetelstat for Diseases other than Cancer. made an individual purchase of 170,940 shares of the Company’s common stock. The answer to that question is long and would take up an entire blank page. Fish Jr, Biopearl, kmall, and every. 13 that it achieved encouraging results when it turned its vaccine technology against cancer. With all of the handcuffs placed on docs these days (read "you need prior authorization for that") the fight to let doctors be doctors is valid and valuable. As we approach the NDA acceptance date, if you are feeling a little anxious, ask your self the following: 1. Just today, Nov 13, 2023, the European Medicines Agency approved a modification to the Imetelstat Paediatric Investigation Plan to allow imetelstat to be administered to children between the ages of 28 days and 18 years with MDS, JMML, …. These colors are caused by different proteins and pigments found in the blood. Syros Pharmaceuticals (NASDAQ: SYRS) announced initial data from its Phase 2 SELECT-AML-1 trial evaluating tamibarotene with venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia (AML) and RARA gene overexpression. by biopearl123 » Fri Mar 29, 2024 4:50 pm. Our KOL's have met this head on and reassured that they have plenty of experience handling these issues and of course they do as Dr. IMproveMF is a Phase 1 trial designed to identify a safe dosage regimen for the combination of Imetelstat + Ruxolitinib in a frontline MF setting. As someone else previously mentioned, at least the issuance & selling of new …. I didn't realize that even though Imetelstat works better on RS- than RS+, the RS- population outnumber RS+ about 3-1. Just the newer classification system that up's more patients out of lower risk categories and highlights that there is utility in more advanced classifications going forward. Rizo's unenviable position as CMO for Geron. (CMG) announced a profit for its fourth quarter that increased from last year but missed the Street estim (RTTNews) - Chipotle Mexican G. by LWS » Mon Mar 04, 2024 11:07 pm. erythropoiesis stimulating agents (ESA). by biopearl123 » Tue Jan 30, 2024 5:36 am. It appears however that the placebo group was also subject to these events although not all were cytopenic events. Open Public Hearings (FDA) Thanks bp--- It appears that we will have ample opportunity to interact with the FDA concerning their obligation to approve the NDA for patients' unmet blood cancer needs in a timely way. THE HEARING WILL BE HELD AT 450 GOLDEN GATE AVENUE, SAN FRANCISCO, CA 94102 IN COURTROOM 12, 19TH FLOOR ON MAY 9, 2024 AT 8:00 A. Re: A note from your board moderator. i was thinking the same thing - i believe Oct 25 was the deadline for submission - I would like to know the response from the lady in the news report, she sure seems happy with imetelstat. PDUFA date of June 16, 2024 for imetelstat in transfusion-dependent (TD) LR-MDS* MAA review completion expected by end-2024, with potential EU approval and launch in 2025. Additional Thoughts (Wizard --- YMB (6/15)) Investor conference was interesting. My guesstimate is Geron is at about $1. I would suggest you requesting Bp personally to have your post in this thread removed. Saturday, December 10, 2022: 2:30 PM. As you state, 30% of the patients have to die in order to trigger the first data look. HI, nothing new I have seen from the patient forum area. Phil predicts more winter far more often than he predicts an early spring. I'm also not aware if we're somewhat …. good penny stocks right now The way you start your morning can make or break the rest of your day. Abstract Approval of new agents to treat higher risk (HR) myelodysplastic syndrome (MDS) has stalled since the approval of DNA methyltransferase inhibitors (DNMTi). A mix of inflation, lingering international travel restrictions in some parts of the world and geopolitical tension in Eastern Europe will keep domestic hotel costs high this summe. Former employers: Novartis, GlaxoSmithkline. As far as I can tell from John Scarlett's comments, everything is on track and ready to go. Can ASH oral and poster sessions later this week present any new data/information on IMerge trial in addition to the Lancet publication. The (MOA) will be the subject of many research publications going forward. John Scarlett told us (fireside chat) that 2024 will be the time to think about partners and collaborators. Big implications for Imetelstat. This entity plans to compare metadata from the Luspatercept studies with IMerge with plans for this evaluation to. 0 (new formulations), EAP (ongoing) and NDA approval (coming soon), that Geron is in the driver's seat. by LWS » Wed Apr 17, 2024 7:43 pm. by LWS » Fri Dec 22, 2023 4:39 pm. I believe we can finally concentrate on the PPS. Jan 30, 2024 · On January 30, 2024, the FDA. by LWS » Mon Apr 17, 2023 5:39 pm. Mar 25, 2024 · CHICAGO-- (BUSINESS WIRE) -- MAIA Biotechnology, Inc. 2 days ago · In total there are 23 users online :: 0 registered, 0 hidden and 23 guests (based on users active over the past 5 minutes) Most users ever online was 379 on Thu Jul 29, 2021 4:50 am. In the beginning, Erythropoietin seems to work for my mother but now we are back to the same condition, her Hb is dropping in 2-3 months and she needs blood …. watching the webcast today I feel even more strongly that they are trying to hold off as long as possible on a european partner - I feel they are hoping to sell without the complication of having a european partner - the interim analysis for MF will be the first half of 2025 as will the. 1 Imetelstat is used to treat patients who are relapsed or refractory to or ineligible for erythropoiesis. Imetelstat--safe, unique, effective. Wow, when somebody writes “my life depends on it”, it gives you pause and makes you realize the gravity of this decision. Be nice to have some clarification here. Imetelstat is an investigational drug that selectively kills the malignant stem and progenitor cells in the bone marrow that cause blood cancers, such as MDS and MF. suzanne williams swift river by kmall » Fri Mar 01, 2024 12:14 pm. Michael Bloomberg, business magnate and former may. Imetelchat is for Imetelstat and Geron. Subforums are searched automatically if you do not disable “search subforums“ below. They didn’t come up with this themselves. Apr 11, 2024 · Rock Star status. While my topic may skirt the fringes in some folks opinions here, it is affected by the FDA. Today, job-hopping has become the new norm resulting in better benefits and a salary increase for Get top content in. Playboy News: This is the News-site for the company Playboy on Markets Insider Indices Commodities Currencies Stocks. Interesting item I excerpted from a continuing education quiz for doctors that I received via Clinical Care Options and Amer Zeidan. The fight to white out the black box. After posting the JNJ-74856665 CT patient profiles of Ben Bennett (LinkedIn) and Eliana Keeling (Daily Mail UK), it really baffles me why Geron IR hasn't done the same???. Also there is competition for patients, that’s just a sad fact of enrollment challenges. my mistake - have gotten used to disappointment - would be nice if we could get approved a couple months early. The meeting will be open to the public. by huntingonthebluffs » Sat Apr 06, 2024 8:34 pm » in ImetelChat. info Board index ImetelChat; Search; What’s bad is good? Forum rules - Comments must be civil and on topic. Joined: Thu Jul 14, 2016 2:00 am. 2024 should be quite the year for us. My name is Sharon Sams Chandler and I am a 59 year old woman who lives in Roanoke, TX. Most small biotechs would probably not announce when they file, only when they were accepted, for fear of subsequent rejection and the loss of face that would inevitably follow. Comments submitted before Feb 29th will be presented to the committee. The likely scenario is that Geron provided the numbers for the 2006 and 2018 guidelines and then made the case for why the 2018 numbers should be used. We know exactly what will happen. As outlined by other board members, these are substantial, many of which are tied to future company milestones. Re: Hundreds of views every day. by cheng_ho » Thu Feb 29, 2024 2:35 pm. transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic. Off-label uses will come into focus. info Board index ImetelChat; Search; New article Hat tip to YMB. by biopearl123 » Fri Mar 15, 2024 3:28 pm. Zhears - These 50 New positions with a salary in the $175-185,000 range translates to approx $9-10M/yr. This is based upon publications in prestigious medical journals, KOLs, and ASH2023 (December 9-12). The Price Per Share (PPS) will be the focus for a while. , June 29, 2023-- (BUSINESS WIRE) --Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that an Expanded Access Protocol (EAP) is available for imetelstat, the Company’s first-in-class telomerase inhibitor. Tefferri and temporally may have been related to the rupture in relationship with Dr. With the discussion of Ferroptosis comes the discussion of Imetelstat for diseases other than cancer. Will check my private emails as I think you have that address. tnt super fantastic forum My name is Sharon Sams Chandler and I am a 59 year old woman who lives …. 3 (3)" - June 1, 2020 "In conclusion, from the 3 indications mentioned (MDS, MF, AML) here we can now project anywhere from a $5. Mistergern, Thanks for the reply. Certainly, JS knows more than he is telling us about partners and buyouts. Just in from Rockefeller paper, everything we know is wrong. I just wanted to highlight the great preparation, composure, and representation by Faye and team. FYI for this October event, doubtful we’ll have the ability to view, or receive any video, transcript or notes for the meeting. The modular NDA has been completed, summitted, and has a very, very high probability of being accepted and approved. Nov 28, 2023 · Re: New Board Member.