Replies to post #92472 on Avid Bioservices Inc (CDMO)

[drragmop]

"I was at Genentech for 9 of his 17 years, and was in clinical development, not a dept mgr of regulatory(regulatory had no role in analysis of trial data). I can think of 10+ ph 2 trials at genentech that reached statistical significance during his time. Why would he say that?"

Maybe someone should resolve this at the meeting.

[unpathedhaunt]

How many times has Dr. Garnick been consulted by the FDA (and others?) to evaluate trial design and/or statistical significance?
Perhaps these are the trials to which he refers.
"Having personally been involved in the evaluation of over 30 Phase II trials over my career, none of which ever achieved statistical significance, including many of today's blockbuster biotech products"

[mojojojo]

I'm not here to defend Garnick's statement, I'm just trying to get to the bottom line of what's relevant. It's possible that he was referring specifically to the endpoint of survival. If he was, I think his statement would be accurate. Either way, it would be nice to get a clarification of it.

Getting back to relevance. This statement, taken by itself, bears no relevance on what bavi did in it's 2nd-line NSCLC trial.

1 of the original 3 avastin ph 2 studies were stat sig
The lucentis ph 2 in AMD was stat sig
xolair ph 2 was stat sig

I don't care what lucentis did in AMD. I don't care what xolair did in asthma. I've looked at avastin and don't recall seeing any phase 2 results as impressive as bavi's 2nd-line NSCLC results. If I had, it would be relevant.

I was looking at this discussion over on the BV board and found this by NP1986. #msg-79465393

We don't yet know that anybody is still alive because of bavituximab. If bavituximab shows a statistically significant overall survival benefit in a large, well-designed phase III trial, then we can be more certain that bavituximab actually increases survival.

So I think he's saying that in most cases the definitive viability of a drug can't be established until the phase 3 results are in and bavi falls into that category. I agree with that. On the other hand, I'm not sure how profitable an investment strategy that's based on this type of analysis would be.

All IMO,

mojo

[lurker100]

I can think of 10+ ph 2 trials at genentech that reached statistical significance during his time. Why would he say that?

Could it be that the stat sig above was for primary endpoints rather than MOS which is what Dr. Garnick may have been referring to. I haven't checked this out, but I wouldn't think Dr. Garnick would make a statement that could so easily be refuted.