Avid Bioservices Inc (CDMO)

[biopharm]

The FDA would NEVER approve ANY drug for an indication where the pivotal phase III trial was stopped for futility at the first look in.

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.

Guess what happened to those thoughts? They were wrong and 100% completely wrong.

Now that the SPOTLIGHT is on certain ones, the FDA would seriously have to consider Sunrise Phase III, as long as the Bavi arm was a success (already confirmed by Peregrine) and as for the other arm? Heck... maybe all Garnick has to do is submit his case and the valid reasons why the control arm did things not possible back during the phase III Opdivo trial : )

The SPOTLIGHT is ON