Avid Bioservices Inc (CDMO)

[exwannabe]

Crap article . Very very funny to read, writer says drug basically doesnt work BUT fda will approve for ph3!!!!!

The linked artical seams to be fairly reasonable, and certainly higher quality than most of the blogosphere junk.

Half the artical is explaining the process, and he gives several examples to support his point that the FDA is not a gatekeeper for enterring P3. And there are many other such examples where companies have gone with poor data (subsets, no P2 at all, ...).

The FDA does insure that a trial has enough justification for risking patients. The FDA will advise about a trial being suitable for a submission. But they are not blessing the P2 data as being strong enough to demonstrate that the drug works.

On to where he comments on Bavi.

He calls the P2 data a "mess". Is that description that far off? I would think that by far the most important item for "clean" data is knowing who is in what arm. If they lose track of this, that seams like a mess.

He notes that the 4.4 mos advatage might have been adversly effected by the arm combination, so the "real" number might have been bigger. He mentions the data was not stat sig. Sounds close enough for a quick summary.

Then he calls the P3 trial a crapshoot. Trials have risks. Novel drugs with unknown MOAs are risky. Certianly the strength of the P2 data plays into how much risk. There are plus points to be made (at least they ran a randomized trial, even if the dog ate the homework). But there are minuses, mainly a totaly unknwon of what the F happened along with a general distrust of management.

Craps is about 50-50 (pass line). That is not an irrational number to toss out right now. The bear case is certainly lower, and the bulls is certainly higher. Qho really knows?

BTW, nowhere did he state or imply that bavi does not work.