Avid Bioservices Inc (CDMO)

[exwannabe]

exwannabe, you were adamant the coding error would invalidate the trial and keep it from being submitted to the FDA as support for moving bavi into phase III trial.

Now we know first hand pphm's goal is indeed to submit it to the fda.

So, where do you stand now?

cheers

I would have to reread my posts to see if I ever was adamant on the subject, vs. just having an opinion that it was unlikely.

I honestly have no idea what level of evidence the FDA expects to see before allowing a drug into P3 trials. On the safety side, I would expect the data would be salvageable. Many drugs have gone into P3 with poor quality P2 data (ONTY's recent failure was based on a P2 subset analysis), so the stsat validuty is not a blocker.

I am adamant that the data would never serve as proof of effeciveness. Would not even bee supportative data for a future submission.