Replies to post #267948 on Avid Bioservices Inc (CDMO)

[vinmantoo]

I remember the same thought process back after the dose swapping of phase II between 2 of the 3 arms and some never thought the FDA would and could never accept anything from that phase II and it was said that phase II would have to be repeated by Peregrine again.

Please stop. Getting the go ahead to run a phase III is far different from getting FDA approval. Doxcetaxel was in all arms of the phase III trial and no safety signals were obvious in the combination. There would be no reasons for the FDA to not give permission. If some here had a different view, that was their misunderstanding.

I said it was a stupid move by PPHM to try and go to phase III and that they should rerun the phase II because PPHM didn't even have a solid phase II trial to base their phase III design on. As far as the FDA, my point stands. The FDA would NEVER approve a drug that failed at the first futility look-in of the pivotal and only phase III trial of that drug.