I may be naive (oh, really)

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biopearl123
Posts: 1670
Joined: Fri Jul 20, 2018 5:13 pm

I may be naive (oh, really)

Post by biopearl123 » Tue Jan 30, 2024 8:09 pm

I may be naive but I view the upcoming ADCOM meeting as a positive (the market doesn’t seem to). This will provide a forum for not only a transparent review of the data, but an opportunity to hear from, well, just about anyone. You can be sure that list will include patients, their families, physicians, KOL’s and perhaps include some analysis of how the critical shortage of blood available for transfusion (the largest in 20 years) might be positively impacted. And it’s not just about blood, it’s about donor quality, collection, storage, administration, burden of travel on patients and families, transfusion reactions, blood borne pathogens (minimal risk there but not 0) etc. The FDA has been working on reviewing rolling submissions so after the ADCOM (if it goes well) they might not need all the time between March and June to make a determination. In the meantime, show us the bone marrow not just the markers!

jayfish101
Posts: 128
Joined: Tue Feb 23, 2016 5:48 pm

Re: I may be naive (oh, really)

Post by jayfish101 » Tue Jan 30, 2024 10:21 pm

I agree with you biopearl. I hope its just a matter of the market slow to digest the news, as often is the case with geron. The March evaluation and recommendations fit better with Geron plan to launch product in June. Hmm. Never understood how they could plan for that with PDUFA in mid June, but now I see how it could happen.

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