Avid Bioservices Inc (CDMO)

[exwannabe]

Why isn't all the data from those patients considered blinded?

The analysis of all 592(?) patients up to Feb(?) was the final analysis of the formal blinded trial.

At that point in time, the trial was unblinded. Patients were told if they were on treatment or not. PPHM continued to follow the patients (as is normal), but that data is follow-up, not the formal data endpoint.

But all this is a nit on the story. The trial endpoint was OS in the entire population. That failed, and failed badly (OS 10.7 vs 10.8 months).

At that point searching through bunches of subsets is worthless for FDA approval. And despite what CP says, 200-240 was a subset. And likely one of several dozen. With 20+ such, you would be reasonably likely to find one with P<.05. Just like the blue jelly beans.

There was never a SUNRISE BLA in the cards. Garnick gave the correct answer to that idea when he laughed.