Avid Bioservices Inc (CDMO)

[Protector]

EndtheFed, I see where the problem is now.

You are referring to the PR were PPHM combined both arms 2013 (that was one of the POSSIBLE choices, they called it the CONSERVATIVE choice).

On this board, since we now know exactly what happened with the dose switching and that it was in the disadvantage of Bavituximab we reversed back to the Sept 7th 2012 results (PR and Chicago conference) because we know now that they are best representing Bavi's potential (while those for the FDA EOPII meeting were just to make sure that the FDA could NOT refuse the PIII design approval due to the dose switching. So PPHM entered the least advantageous, but also lowest risk, solution).

That is why I mentioned Dr. Brekkens NYAS in New-York presentation because there for the first time PPHM themselves indicated in public that the real results were better then the ones they filed with the FDA.

So you must work with the Sept 7th results if you are going to make any conclusions on Bavi's performance in PII or potential performance in SUNRISE.

The FDA needs P-value p < 0.02, not 0.05. 0.05 is very popular for statisticians, in maths etc but the FDA is more severe. Bavituximab in combined PII Arms was statistical significant because it scored BELOW 0.02 with 0.015. The two arms alone were NOT because they were above 0.02. We know today why they didn't have a chance.

The pollution of the control arm with 25% Bavituximab maid that arm exceptionally strong and BOTH as well the 1mg as the 3mg arm compare with the SAME control arm.

If you keep saying the FDA uses p < 0.05 as the rule then maybe that changed but I would ask you if you could substantiate that with an FDA document because the 0.02 has been substantiated here on the board with the FDA guidelines and the slides of their presentation. For now it is 0.02 until some prove that it is 0.05 surfaces but I have not seen any, but I could have missed it. But you must have seen it because you keep saying:

I am sure you know that the FDA commonly requires a P value or 0.05 or better to demonstrate statistical significance in clinical trials.

No, I don't know, I am only aware of p < 0.02 so please educate me with links to FDA regulation, because you seem to know, I honestly don't. I'd LOVE it to be 0.05 because then tomorrow I buy a few 100K extra PPHM shares because at 0.05 I think we get stopped at 1st look-in, at 0.02 I am not sure at all.