Avid Bioservices Inc (CDMO)

[eb0783]

Since you are still posting stuff that I don’t understand, let me repeat in another way.

On 7-16-12, Rob Garnick said this about the ongoing Bavi+Doce randomized 2nd-Line NSCLC Ph.2B N=121 trial (which was going to double+ MOS vs. Doce ctl-arm): “I’ve seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I’ve ever seen. So, I’m very comfortable proposing an [EOP2] meeting with the FDA for Q4’12.” Then after the sabotage was fully researched, it turned out that the data was even better than he had seen (since around 25% of the control arm got some bavi). Not only does nothing in this hindsight look reckless but it is already paid for (a lot of people here said they could never pay for it themselves).

you said

PPHM management is horrid. I stated on this board after it was revealed that the small NSCLC trials was corrupted and had significant numbers of dropouts/lost patients, that the prudent move would have been to rerun the phase II using a larger number of patients. Instead PPHM was reckless and moved into a large phase III trial without either solid data to base in on or a partner to help finance it.

This "small" N was BIG enough that the FDA could have accepted it for approval since it was designed as a registrational trial. We did not submit it for approval since it had been sabotaged but management used the data (which all of the naysayers declared, as fact, that it would never be accepted) and miraculously got a Phase III approved and miraculously acquired Fast-track designation. You can belittle them all you want but the facts say otherwise.

I have a "LITTLE" more respect for Garnick's opinions and statements than those I read here.