New Corporate presentation
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- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
Re: New Corporate presentation
Is it normal for it to be released in advance? I don't recall them doing it at this conference before.
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Re: New Corporate presentation
Yes, I have definitely seen them do this in the past. bp
Re: New Corporate presentation
Fast Track was achieved much earlier in MDS Phase II because the goal of Transfusion Independence was achieved quickly for patients. Now the MDS indication is moving into late stage for patients with specific biomarkers, and again these TIs could come quickly. Within 6 months we could (*should) have numerous patients experiencing therapeutic effects, and achieving the TI goals...
Fast Track obviously took a lot longer with MF, obviously because the therapeutic effect in this case is life. Living longer, much longer than expected. So the world renowned experts and Geron experts are marching into the FDA with a ‘regulatory strategy’, which is essentially don’t make us wait another 4 years to measure out the longer lives experienced by these patients, get these to R/R patients with no other decent options at all NOW.
...and, Imet just needs *1 indication approved to start seeing both off-label use and a massive increase in academic / clinical studies in combo.
Fast Track obviously took a lot longer with MF, obviously because the therapeutic effect in this case is life. Living longer, much longer than expected. So the world renowned experts and Geron experts are marching into the FDA with a ‘regulatory strategy’, which is essentially don’t make us wait another 4 years to measure out the longer lives experienced by these patients, get these to R/R patients with no other decent options at all NOW.
...and, Imet just needs *1 indication approved to start seeing both off-label use and a massive increase in academic / clinical studies in combo.
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Re: New Corporate presentation
Ryan, good points, thank you. I believe eventually combo is the answer to patients needs much more effectively, and will accelerate Geron's success.