Avid Bioservices Inc (CDMO)

[exwannabe]

Why do so many and especially Biovalue board guys harp on stat stig for phase II trials.,are most phase II trials designed to be stat sig? I thought most were designed to show safety and and enough activity to be approved to go to ph III.

Has there been anything that has shown to be effective for pancreatic that isn't some form of chemo agent? My guess is if Bavi shows good lung data and partners then we will see Bavi down the road for pancreatic based on subsets or in combination with Gem and Abraxane

I generally agree with your post, I was really disputing the overall tone of CPs post (I had to post the first one quickly because I somehow hit submit as soon as I posted the title).

I suspect the OS endpoint on pancreatic was chosen so as to have a moonshot on approval if it hit stat sig. But it is always hard to be stat sig of OS in a trial of this size.

The published numbers on the trial really were not bad. Hell, let me rewrite the PR:

"Unfortunately the trial was not able to be statiscally significsnt on the overall survival endpoint, but it did show a solid trend with HR=.75 (P=.12). Additionally the key pre-specified secondary of ORR was nearly double that of the SOC arm".

I would be quite satisfied with such results. As a matter of fact, a bio I own had almost exactly such and the drug is being taken into P3 trials.

The most negative item in the PR was the last paragraph were PPHM makes clear they fo not have a direct path to P3 based on this trial.