Avid Bioservices Inc (CDMO)

[Protector]

EndtheFed, that are two questions.

1) PPHM vs CSM

- the trial is scheduled for OCT 2015, not SEPT (see cheynew's updates)

- we all hope your assessment is correct but a Jury is a Jury! There is an unpredictable factor in it. Although at least one element that PPHM will for sure bring to the table, if not settle up-front, should take all doubt away, it still remains a Jury that will vote.

2) Statistical Significant

- you need to separate TWO things. The raw results (the beating of the SOC by x% where can be 1mg, 3mg or combined arms result) and the measurement of what the probability is to do this again under comparable circumstances.

- Math guys often use 0.05 for p-values to claim something is statistical significant, the FDA uses > 0.02 which is more severe. (actually SMALLER NUMBER is BETTER, NULL-Hypothesis stuff). I think there is your error and the answer to your question. You reversed the 0.02 (FDA stat.sig) with the 0.05 (not FDA stat.sig).

- You are correct 0.02 does NOT represent a % itself it can be translated into a % and is indeed not as close to 100% as the small p-value may let believe. But that doesn't matter because the FDA has set this boundary so they knew that relation upfront and judged it to be satisfying.

- PPHM achieved stat.sig WITH COMBINED arms. And we KNOW that the placebo control arm got BAVI and the 1mg Bavi arm got Placebo. Therefore performed BETTER then it should have and the 1mg Bavi arm performed less good then it should have. We also know that n was 41/40/40.

- For SUNRISE we have n=291/291 (randomizing is 1:1 for 582 patients) and we are aiming for 50% SOC improvement or 7.5 months which is LOW compared to the PII results.

So the SUNRISE stat. sig. will profit from the increased n, the much higher probability of being able to beat SOC by 50% vs 100+% and from the fact that the arms are not polluted by sabotage in a counter productive way. The ECOG is what can differ but in all cases we get very sick patients for BOTH arms.