Replies to post #243037 on Avid Bioservices Inc (CDMO)

[md1225]

As I noted in my article Opdivo was approved on first look weeks after BMY announced fully enrolled in Check 57 Opdivo only increased mos 11 weeks over doce alone.

http://seekingalpha.com/article/3657006-peregrine-pharmaceuticals-the-art-of-the-deal

[hayward]

sunstar

I previously posted that IMO total enrollment at this point is unnecessary considering the life expectancy/eventing of patients. If we believe Steve that enrollment is on track I feel we have enrolled more then number of patients required for the two lookins. At this point it is only credibility of management to fully enroll that is at stake.

Michael

[exwannabe]

That is based on the 2:1 Bavi Doce ratio that we saw in the phase2 trial.

Huh? However one wants to parse the P2 data, never saw a HR of anywhere near .5, and even that will not lead to a 2:1 event ratio (other than at day 0).

The First-Look-in, 33% eventing of the 582 enrollment would be about 192 events.

No, it is not. The 1st look is at 33% of the planned final event count. The company has not released that number, but likely around 500 events. So IA one would be closer to 166.

If 127 events (66%) are from the Doce arm, and 65 events (33%) are from the Bavi arm, what might the IDMC recommend?

Well, your numbers are absurd. But regardless, why would PPHM want to stop the trial while it was non stat sig? A single trial not run to plan and not stat sig is not going to be looked at well by the FDA. Would it not make more sense to run another 4 months or so and have proper data?

If Bavi works as most longs here hope, then mid '16 (IA 2) is a reasonable timeframe for Christmas. If it works moderately, then mid '17.