Replies to post #249430 on Avid Bioservices Inc (CDMO)

[exwannabe]

...if Bavi can come through in Sunrise and the TNBC trial, I like to think the FDA and the BPs will react promptly and positively.

The FDA will act on a BLA submission, not react to some trial data floating around in the universe.

SUNRISE could do well and get an early halt this summer at the second look, if so then yes, the FDA could have a BLA plopped on their desk by EOY for them to start chewing on.

W/o a halt on the second look, I am hightly skeptcal of an unblinding before summer '17. The numbers just do not work. I know what SK has said (unblind this year), but I simply do not beleive it. Whatever the final expected number of events is planned for, they expect to be 1/2 way there by summer. Just does not add that the second 1/2 of those events come in 6 months when the rate will be slower (less at risk).

As far as TNBC, that trial is looking for the first phase (P2) results EOY '17. Then they will initiate the pivitol P3 phase. So one would be looking at several years before the FDA would have anything on their plate.