Replies to post #261142 on Avid Bioservices Inc (CDMO)

[nh]

I keep wondering that too, but then stop to think 'why am I questioning a renowned expert' in trial successes. But I do wonder why the narrow margin of separation with so much at stake and so much would have gone into the trial at that point such that an extra margin would have been some cheap insurance.

[exwannabe]

1. Given the MOA of Bavi, why would the first look-in be scheduled at it was? Why not wait to make sure separation had occurred/reduce risk that it hadn't occurred?

That is a question I also would like to know the answer to. 2 looks this early, at 33% and 50% is strange. Even though there will be some points out 1-1/2 years, the data will be so thin there as to be unreliable.

50% and 75% or 60% and 80% would seem a bit more reasonable.

I doubt we will ever know the answer to this question (unless down the road Bavi gets approved and it shows up in some FDA document).

2. Is there any reason in the world that Garnick may have wanted the trial to unblind early??

No.

The only early data they (it was PPHM's call) would want would be in case the pre-planned efficacy halt was triggered. Any other halt makes the trial data useless for establishing efficacy with the FDA.

Ironically enough, if Garnick did want this result, the best explanation would be that he really was the saboteur :-)