Replies to post #155972 on Avid Bioservices Inc (CDMO)

[cheynew]

Thanks mojojojo. Very informative as always.

[asmarterwookie]

you da man mojojojo.. "a laboratory or physical sign that is a direct measure of how a patient feels, functions, or survives and that is expected to predict the effect of the therapy"

"surrogate endpoint"

May all the brave Sunrise patients and those who follow in subsequent trials "feel" better and ultimately be well.


wook

[Protector]

This is the BEST information about the AA, and in particular AA related to NSCLC PII and PIII, 1st ln and 2nd line that has ever been posted.

My dog understood it and the concierge will too in a couple of hours :)

Bottom line: We already qualified to request an AA in 2nd ln NSCLC PII (with our OR 17+% while only 8% was required). However we didn't have the Fast Track, but we have it now.

Garnick was correct, better no BTD but get an AA based on PII OR results once we have a Fast Track (He of course will have known that we had a FT application pending or intended to file one and he knew that the FDA's response period was 60 days).

He also must have figured (knowing for sure what is in the slides posted by you - mojojojo) that they would not have to wait for PIII interim results but could file based on the PII, so that when the interim results become available we already have the AA.

At that moment we can enter a scenario of Halting the clinical trial early and moving into the approval (now shortcut to 2 to 6 months because we have the FT).

I also understand now WHY we needed to hire those technical writers and regulation specialists for NDA, etc writing so early.

The FT grants us the opportunity to start filing parts of the NDA, and have the FDA process them right away, without needing to wait for the EOPIII meeting and submit the complete NDA filing in one piece.

I can see how this strategy, undoubtedly Garnick's idea, will lead MUCH quicker to commercializing then BTD would be, still leaving ALL DOORS open in that area for Bavi Breast!

mojojojo, this post of yours makes MORE then just my day. Best content contribution of the year, should be a STICKY!

Thanks, Thanks, Thanks!!!

[EYEBUYSTOX]

I would assume that ORR precedent you cited was assuming statistical significance, right? Even the original ORR data presented on Sept. 7, 2012 was not statistically significant (.2069).

And do you know why the placebo group didn't even have a p-value assigned to it? I found that strange.

http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=705521

I highly doubt payors would agree to reimburse a drug that uses a statistically insignificant surrogate endpoint that was approved under accelerated approval. What a mine field this process is with so much fuel for the shorts. Fargo screwed us royally. All IMO.

[exwannabe]

I can see the company now setting the wheels in motion for AA.

It would certainly be a legit option to use ORR in Sunrise to garner an AA.

But to do so, they need to make this the predefined primary endpoint. They most certainly can not define the endpoint to be OS, then say "hey look at this ORR data!".

But it really makes no sense for the company to try this path. They would save a year at best, and have a much less clear path.

PPHM has said time and time again that they bare taking the path of following the P2 trial with a P3 OS based trial. This is a reasonable position for PPHM to take. To change the trial design in order to gamble on another endpoint would be dubious.

P.S., I assume you are talking about AA forward going with Sunrise, and not AA on existing data (which is simply absurd).