Replies to post #274387 on Avid Bioservices Inc (CDMO)

[JJ1223]

Has a company ever failed a phase III and said they are not going to review the data?

No.

It is safe to say that no company has ever participated in a PIII trial (success or failure) that has not reviewed the data. It is part of the process of understanding the science.

[Protector]

corporal, yes. Probably 100% of them don't say that they will review the data if they failed phase III.

Then again, almost 100% also do as does PPHM and say that they are going to review the data BEFORE they say the trial is failed. And that is normal, because the DMC only gives an advice and data might contain errors in there advantage or disadvantage (see PII 2012).

Therefore also 100% of the those that think their trial succeeded do review the data because again, THEY ALSO still have to male their case for the FDA.And we saw for instance with Intercept Pharma that what is said or claimed first is not always what comes out later, even if as they were the trails was stopped early for EFFICACY.

Again, the DMC gives an advice based on sponsor guidelines and couldn't care less what these are as long as the FDA approved them as part of the clinical trial protocol. It is the SPONSORS responsibility to decide.

And a good thing PPHM did review the data otherwise the would have believed that the trial might as failed, as some on here believed fro a while by lack of understanding what a DMC advice actually ONLY is, while now it seems that have statistical significant improvement of overall survival of the Bavituximab+Doce patients over the Placebo+Doce patients.