Avid Bioservices Inc (CDMO)

[EndtheFed1776]

CP,

So they just changed the trial date. Thanks for the information. You saved me a visit to Pacer. It will be interesting to read the judge's decision on the motion for summary judgment.

In regard to statistical significance, you got a few things wrong. First, the FDA requires a P value of 0.05 or less to show that the drug is responsible for meeting the end point. The FDA does NOT require a P value of less than 0.02 (~98% probability) like you said. The FDA will or may only require a P value less than 0.05 when there is only one controlled trial showing efficacy. Why did you state something so erroneous?

Second, the number 0.2, which I posted, (not 0.02, which you posted) was taken from PPHM's press release on the P2 trial. This number was NOT statistically significant. It only represents something like an 80% probability that the drug is working. But like we have both said, bavituximab was competing against itself since the control arm included the 1 mg vials. The number 0.2 does SUGGEST the drug MAY be working, but it does not meet the statistical significance threshold. Therefore, it represents a null hypothesis.

You have said repeatedly that Peregrine showed statistical significance in their P2 trial. I have asked you to explain how you arrived at this conclusion. You have not given a cogent explanation. Thus, I am presently of the view, which is in accordance with PPHM's press release, that P is 0.2. We have a null hypothesis and will continue to have one until such time as the statisticians look at the trial in the interim or at completion.