Avid Bioservices Inc (CDMO)

[tradero]

Nice thoughts Danny, wish they become true.
However I have my big doubts about getting Bavi approved at the 1st look-in.

If 156 events are needed for the 1st look-in and let's say that at 1st look-in Bavi Arm had only 20 events.... you are right that the 136 to 20 ratio may be there (and it is outstanding to say the least!) but the Placebo Arm would need 167 events to mark its Median. Not to mention the other statistical parameters that seem to have to be considered for a proper statistical measurement of the trial procces.

My idea of the FDA is of a merciless and cold agency that would not take a step outside the established protocols unless some political pressure steps in. So I doubt the trial would be stopped at that point... However in mid-April the Placebo Arm could have passed the 167 events which at least would have established its MOS.

I dont know if such a review can happen between look-ins. I am afraid we would have to wait until 2nd look-in, where with a possible ratio of 203 to 30 and the rest of statistical parameters in place... I believe the FDA will do something about it (around July?).