Avid Bioservices Inc (CDMO)

[Protector]

exwannabe, I think that calculation needs a slight change. This is how I see it.

PPHM is expected to get 33% (1st look-in), 50% (2nd look-in) and 80% (final unblinding) of the # of patients needed for calculating the unblinding 80% as specified in the trials protocol between PPHM/FDA.

We know from the PPHM PR that when 90% of the 582 patients were enrolled (in DEC 2015) the number of REQUIRED patients to unblind were enrolled already. So that number, required by the FDA, is MAXIMUM 582*.90=524 (rounded up).

That is a MAXIMUM because PPHM did NOT say they needed the FULL 90%. They just said that with 90% enrolled all needed patients to unblind were enrolled.

33% of 524 = 173 events for 1st look-in
50% of 524 = 262 events for 2nd look-in
80% of 524 = 420 events for total unblinding

So I think the 466 number is incorrect if the reasoning above is correct, which I think it is.

Question: How can they not have assigned an alpha? The FDA, if not specified otherwise, uses 0.02 as the alpha. So p<0.02 would be stat. sig. In math-stats it is often 0.05.

When did SK say there was no alpha? If that would be correct the 2nd look-in cannot check for efficacy because it would not be possible to see if that result was statistical significant.