Replies to post #267945 on Avid Bioservices Inc (CDMO)

[unpathedhaunt]

Bavituximab worked as expected in SUNRISE. No futility for the future as we commercialize Talceptrx. GO PPHM!

[entdoc]

Vinmantu, I was not hedging, but leaving open the small (small to the vanishing point) chance that Bavi could be used in combo with other immunology-oncology agents for advanced lung cancer. As usual (and as said before), the people who really understand what is going on are those who have the postmortem target tumor on a slide, stained appropriately, under a microscope. That tells a story that theorizing on the number of -PS receptor sites left open after Bavi dosing will not tell. Cheers!

[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