Replies to post #218744 on Avid Bioservices Inc (CDMO)

[biopharm]

My advice to you would be to forget about the 9-7-12 numbers.

I disagree 100%. Dr. Rolf Brekken certainly did not forget about these numbers and I hear that he was at NYAS last year and was specifically asked about those Phase IIb NSCLC stats and guess what he said ?

It has been posted here several times that Dr. Brekken "CONFIRMED" that the phase II stats were "EVEN BETTER" than reported.

so shall we forget about the Sept 7 2012 numbers ??

Absolutely not.

Try digging deeper and I plan on attending to see Dr. Brekken this year because I'm sure the question and more specific questions will be asked and I want to hear it all first hand this year.

[eb0783]

Endthefed, Help me understand. You seem to be reasonable but you also seem to be ignoring FACTS. I thought you agreed to my post [which someone decided should be removed]:

"You got it right on!

Thank you for the explanation. What you wrote does imply statistical significance, at least it gives, what seems to me to be, a cogent reason for it. I still need some time, however, to digest "the results WOULD have been much better than P=.0154 IF the patients would have gotten the right drugs." It seems you are right though: if some placebo got bavi, that would have made less placebo patients die earlier and so the P would get larger, but it still turned out to be .0154. And conversely, when some 1 mg bavi patients got placebo you'd have less people getting better, meaning the P value should have gotten larger there too. Let me know if there is something wrong with this logic.

I have reproduced what you wrote below. I also noticed, in reading my original post 218219 in this thread that I erroneously wrote ".02" for the published P of the 3 mg v controlled arm (1 mg and placebo). That number was 0.2. My apologies to CP for this error and the resulting confusion.

EndtheFed1776

>>What you are mixing up is the stats given to the FDA AFTER the 1mg arm and control arms were combined but the original reported P-Value = .0154 for the 3mg +1mg arms combined vs control arm. That is way better than .05 in my book. The original was statistically significant even though some control patients got Bavi and even though some 1mg patients got placebo. Therefore, excuse my non-expert statistical level of understanding, the results WOULD have been much better than P=.0154 IF the patients would have gotten the right drugs.

The 9/24/12 PR simply stated: “In the meantime, investors should not rely on clinical data that the company disclosed on or before September 7, 2012 from its Phase II bavituximab trial in patients with second-line non-small cell lung cancer or any presentations or other documents related to this Phase II trial.”

Now that we know what happened, it is clear that the results should have been considerably BETTER than what was Originally reported on 9/7/12. As the superstar Dr. Garnick stated before he realized the results should have been better: "I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen." Hence the true longs here have no qualms about continuing to add to our pile of PPHM shares. "<<

[Now that we know what happened = Sabotage]

So what I’m saying is, I don’t care what PPHM decided to PR as to their target of 60% improvement for Phase III or what they reported for Phase II after they combined the control with the 1mg arms. I saw a 130+% improvement in what was published so I am VERY confident in surpassing 60% improvement. Thus…..I keep buying on a weekly-monthly basis.

[Protector]

EndtheFed, which proves point, thank you.

1) I posted the p-values that you throw now back on me and have been referencing them all the time.

2) The conclusion is PROVE that your claimed required p-value by FDA p < 0.05 is incorrect because in that case the 1mg/Kg with 0.0268 (which is WITHOUT ANY DOUBT) smaller then 0.05 should have been statistical significant. Yet PPHM had to combine bot arms to get 0.0154 (which is SMALLER then 0.02) to become statistical significant.

3) The conclusion that the Sept 7th results are worthless is wrong. Not only are they THE MOST VALUABLE because they express the closest what we can expect from Bavi in SUNRISE and we DON'T CARE what PPHM had to file to the FDA to ELIMINATE all risk that the FDA would not accept the results due to the dose switching (which was predicted by some the days after the Sept 24th 2012 PR, where the were WRONG AGAIN).

4) You forgot that Dr. Brekken that at NYAS with agreement of Shan and King confirmed that the REAL results were BETTER then those filed to the FDA and the ONLY other result set is the Sept 7th one.

5) AGAIN: IS THERE ANYONE WHICH HAS A REFERENCE TO RECENT FDA DOC RELATED TO THIS P-VALUE DISCUSSION SO WE CAN PUT THAT BEHIND USE ONES AND FOR ALL. THE SLIDES OF THE FDA WERE POSTED ON THIS BOARD. I want to know FOR SURE NOW , because if it REALLY IS p < 0.05 then I am throwing a party this very evening because then we are not just going to make stat. sig. but we will make it HANDS DOWN, possibly even in the first look-in.