Replies to post #107572 on Avid Bioservices Inc (CDMO)

[Bungler]

If being statsig doesn't carry any weight of importance at the FDA to make their decision . . . I am confused

Statistical significance carries much more weight when the FDA is being asked to approve a DRUG, than when the FDA is being asked to approve a next phase STUDY of the drug. At this stage, the safety profile is of more importance that statistical significance of efficacy.

[exwannabe]

If being statsig doesn't carry any weight of importance at the FDA to make their decision then we actually have super results because in that case the 3mg arm is under no dispute delivering a super MOS and it was not affected by the error.

Yes, there is some dispute.

First, there were 6(?) patients in the 3mg arm who at 6 months were neither dead nor alive, they were reported as lost. If the reason these patients were LTFU was because they were dead and convienty not recorded, this would nullify the improvement in OS.

The number of LTFUs was high and unbalenced. To ignore this is a mistake. Does it mean the drug failed? No. But it dooes mean there is more reason for uncertainty.

Second, many will not trust data comming out of this company until it can be vetted. They spin. The primary endpoint of the 2nd line trial (as defined by PPHM) was ORR. This failed. Then they tried OS for the 1+3 vs 0 arms blended. This data turned south, so now it is non stat-sig OS for 3 vs 1+0. Seriously, take enough measures and you will always find something positive.

Bavi may or may not work, but this "gold standard" trial certainly did not do much to prove it.