https://www.youtube.com/watch?v=EfI-CqCMubw
https://www.youtube.com/watch?v=EfI-CqCMubw
Rami says ADCOM in April
Other salient feature, Grade 3-4 neutropenia in 68 % (manageable and transient) but notably only 1% with febrile neutropenia. It’s a stretch and a guess but regarding the need for hospitalization to manage an adverse effect, that 1% sounds very favorable (if it’s accurate). I am trying to get confirmation from Geron but it’s not going well so it’s possible that number could be higher. Could be way off base here. ADCOM and FDA will certainly have to make public and address. If hospitalization rate low and short term for those who need it, could be another ace in the hole. Imetelstat at 6:30.
Hat tip again to Kaz YMB
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Re: Hat tip again to Kaz YMB
Someone on Twitter from the investing side of the world said the ADCOM was in April - and he posted this a few weeks after the announcement of standard review was made public - I think I posted that here
The FDA had boots on the ground at the EHA - wonder if they could have spoken with thr KOL’s and gathered what they need to make a decision without the ADCOM - scarlet said it may not be necessary
I think the FDA must be planning on approval and that is what compassionate use was granted
The FDA had boots on the ground at the EHA - wonder if they could have spoken with thr KOL’s and gathered what they need to make a decision without the ADCOM - scarlet said it may not be necessary
I think the FDA must be planning on approval and that is what compassionate use was granted