ImetelChat

Happy Groundhog Day It appears to me that March 14th will be the first day of Spring for Imetelstat (41 days from today). Everyone is still a bit apprehensive about the outcome, with words such as "shenanigans" being introduced into the conversation. Unless the 'sky falls down', Imetelstat is soon ...

ODAC & CDER ---- Webcast of March 14th ODAC (Imetelstat) meeting =========================== Webcast Information CDER plans to provide a free of charge, live webcast of the upcoming advisory committee meeting (ODAC, March 14). If there are instances where the webcast transmission is not successful,...

Imetelstat in focus and subject of Oncology ADCOM (ODAC) meeting on March 14, 2024 =================== SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. The Committee wil...

Imetelstat--safe, unique, effective My thought is that the data is convincing and the EAP (JS said---could be considered a phase 4) is ongoing. The trials (with minimal safety concerns) have shown positive results in transfusion independence, survival time, disease modification, and quality of life...

ODAC has awakened (The meeting will be held on March 14, 2024, from 9:30 a.m. to 3 p.m. eastern time.) This is the last hurdle to get over before NDA (Imetelstat) approval, that we have all been waiting for. This meeting, as I understand it, is open to the public. The KOLs, patients, and other prof...

Information Management and the Price Per Share This is a chatroom. This thread has to do with the PPS of Geron, which is obviously tied to what the FDA's advisory committee (ODAC and their KOLs) is thinking. Everything looks good medically, as far as I can tell (trials, KOLs, publications, etc.), s...

January 2024 -- From Geron 1/Geron is On Target for a Successful Transition to Commercial Company in 2024. 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. 2/Imetelstat Ph3 dat...

PPS to be Determined by NDA Approval by FDA It has been suggested that, because of Imetelstat's huge potential in combinations, oral forms (aspirin like preventative), IMET2.0 (new formulations), EAP (ongoing) and NDA approval (coming soon), that Geron is in the driver's seat. Obviously, Geron's ne...

MAIA, after Geron, will be the #1 beneficiary of Imetelstat's NDA approval (from ODAC & FDA). 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 cancers across the spectrum, from b...

There is not much to do until the Oncology ADCOM (ODAC) speaks about Imetelstat in one format or another. We know that the EAP continues, and the NDA is under review. Also, John Scarlett has told us that this is his 'quiet-time'. Medically, as far as I can tell, everything looks very positive, with...

I hope Geron posts this fireside chat, so we can all listen and update. =========================== Thank you hunter (YMB) In case you didn’t catch the conference yesterday, it was actually kinda interesting as the analyst firm did their own survey with doctors active in the field that geron is see...

Comparing the Stifel fireside chat (Nov. 14, 2023) & the B. Riley chat (Jan. 18, 2024 -- when available) The chatroom today at B. Riley will add new information. All interested parties need to listen. ===================== by LWS » Tue Nov 14, 2023 10:15 pm Here is an outline of the fireside chat (...

"I have not felt this good or had this much energy in over 5 years. I can only speak for myself but this drug has worked wonders for me with very little side effects --- " -- from Paul C. [/b] ---------------------------------------------------------------- In these days of misinformation, it is ha...

ODAC and CDER are both parts of the FDA. IMHO, with the EAP in place (can be considered a phase 4 -- John Scarlett) the NDA Imetelstat approval is a done deal. CDER considers Imetelstat to be one of the top 10 medicines of 2024. ================= The Center for Drug Evaluation and Research (CDER) i...

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 =================== NO. 10. Imetelstat ▶ Company: Geron ▶ Indication: Lower risk myelodysplastic syndromes (MDS) ▶ Status: PDUFA date of 16 June 2024 ...

Anyway, I believe in Imetelstat now (alone) and look forward to off label uses, combinations, synergies, oral Imetelstat, and IMET2.0 (new formulations). from LWS ================================================================= KTA --- Let's keep this board focused on Imetelstat and its progress w...

KTA --- What is your point? Information, properly presented, is a composite of various points of view, including background information, old thoughts and new thoughts. Some people do not have all the information. I am trying to provide some text that I believe is correct, but certainly can be edited...

ODAC's positive recommendations are critical now. KTA --- You seem to miss the point completely. The point is, as JS has already told us, that ODAC is now operating in a different mode (Vertex example), where, when the data warrants it (which seems to be the case with Imetelstat's unique trial data...

Whatever is being done in the short-run to hold down Geron's PPS, the inevitable outcome is that ODAC (with their KOLs) will overwhelmingly and convincingly recommend approvable to the FDA, which they will certainly accept. NDA approval will follow the functioning EAP, which JS told us can be consi...

EAP and NDA The FDA has a continuing database of information from the EAP (one form of FDA approval). Also, there are no medical negatives that are serious enough or important enough to slowdown the process now. It appears that the FDA (ODAC) has already decided on approval of the NDA. Certainly, G...