Replies to post #112443 on Avid Bioservices Inc (CDMO)

[asmarterwookie]

FTM, thanks. If I understand correctly, it is all or none. PPHM could/would be accused of picking patients that favored a good outcome. Choosing all those affected will remove bias.
Thanks Again. That was bouncing around my head. : )

wook

[jakedogman1]

the bottom line is whether the fda approves a phase 3. kinda like the olympic medal race. how you qualify doesn't matter. are you running for a medal or not. fda yes or no

[Drumstick7591]

Thanks. but once again we are basically no where with all this conjecture and projections and analysis.
We seem to know nothing more than it could be this or it could be that. but we will have to wait to know for sure.

[Thurly]

...I also still feel that one incorrect dose in many patients would have a very small effect on
the outcome of the control arm.

Stepping back from the data, it would seem apparent that the effect was small, but that's not likely to pass muster with FDA biostatiticians like Flemming who is known to be a stickler for data integrity. Drs. Pazdur and Hussain are also sticklers on data integrity. Pazdur will likely be involved in any bavi decision. I wouldn't expect Flemming to remain silent if PPHM tries to make use of the misdosed control and 1mg/kg arm data.

I'd bet bavi makes it to PIII based on the 13.1 months survival in the 3mg/kg arm, the historical data and the sum total of the bavi safety data.