Avid Bioservices Inc (CDMO)

[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!!!