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11/20/20 11:03 AM

#2513 RE: Fosco1 #2512

FDA has hard a decision to make, on one hand, the data is
showing convincing efficacy, the science is solid
behind the data and the medical KOLs should ask and support
stopping the trial for approval, on the other hand, FDA
has to be flexible. I am betting on FDA making the right
decision and stop the trial to file for approval.

lidopete

11/20/20 8:26 PM

#2517 RE: Fosco1 #2512

Looks like Fosco1 was 100% right

Ahjon81

11/21/20 4:06 PM

#2519 RE: Fosco1 #2512

I’m so amazed reading your misleading post. The secondary endpoint doesn’t effect the filing of BLA. Also if the company resigned the trial 8k form must be filed.

Ahjon81

11/21/20 5:39 PM

#2520 RE: Fosco1 #2512

Very funny you actually act that you know about trials design. Venclexta was approved based on phase 1B non randomized trial, 114 patients enrolled. The overall survival was not even listed as secondary endpoint.