Replies to post #218523 on Avid Bioservices Inc (CDMO)

[bidrite]

See also Dr. Brekken's NYAS presentation and Q&A in which he confirms that the PII results are BETTER then what PPHM filed with the combined arms 60% (that is of course ALSO based on the TODAY's knowledge of what happened with the sabotage) or he could not have made that statement. The statement was made AFTER nodding approval of Shan and CEO King was present.

I can personally confirm this as I witnessed it live. Dr. Brekken was asked the question if the results should have been better. Brekken looked at Shan who nodded his approval to talk about it. You can also check my posts on that day as I reported to this board as it was happening.

[itsabouttime]

CP thanks I can stop scratching my head now. Figured a response was in the works.

[EndtheFed1776]

CP,

We don't seem to be understanding one another. I apologized in an earlier post, but it must have been taken down because I don't see it on the board anymore. Don't know why anyone would have done that. But back to the statistical significance discussion.

You say "The requirement of the FDA for 0.02 to be stat. sig was posted in the FDA guidelines and the slides."

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. Are you saying that the FDA is requiring a P value or 0.02 or better for P3 SUNRISE? Or are you saying the FDA wanted a P value of 0.02 or better in order for Peregrine to claim statistical significance for the P2 trial? If it is the former, that is a much higher hurdle for PPHM to meet even with n being much higher. If that is the case, that the FDA wants P = 0.02 or better, why is the FDA demanding a higher threshold for this P3 trial? If it is the latter, that is the first I have heard of such a thing in a phase 2 trial. In any case, I was totally ignorant of the FDA requiring a higher threshold whether it be in the P2 or in the P3. Please accept my apologies.

In my post that was taken down, I pointed out how I was in agreement that the 9-7-12 press release P values should have been higher but for the vial mixing. There probably was statistical significance shown there, but because of the all switching and relabeling there is no way anyone can conclusively state that statistical significance was demonstrated. The company is not taking that position, and it knows the matter fairly well I'd assume.

The P = 0.02, which I was referring to, was taken from the February 3, 2013 press release:

TUSTIN, CA -- (Marketwire) -- 02/19/13 -- Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), today reported data from its randomized, double-blind placebo-controlled Phase II trial of bavituximab in patients with second-line non-small cell lung cancer (NSCLC). Data from the trial has been updated based on completion of an earlier review of discrepancies in the trial and the most current survival data from the trial. Updated results from this Phase II trial indicate a meaningful improvement in median overall survival of 11.7 months in the 3mg/kg bavituximab + docetaxel arm compared to 7.3 months in the control arm (HR=0.73; p value=0.217).

This number, 0.217 to be exact, was taken after the mixup/sabotage was discovered and the data was given its most thorough assessment. Now clearly this is not statistically significant.

So what everyone who is long this stock is betting is that, with a larger patient pool and with no patients in the comparator arm getting bavi, the P value should move from 0.217 in P2 to 0.02 in SUNRISE. I was thinking it would only have to go from 0.217 to 0.5, the latter being the commonly excepted value for FDA approval. But if you are saying, the FDA now wants 0.02, we've got a fairly good hurdle to meet. Are we both in agreement now?