EndtheFed, you either are looking at the wrong PPHM documents or your conclusions are wrong over the complete line.
Since you are new I'll do an extra effort to point you to the correct information. Also know that CJ's IHub PPHM board intro section has a gold-mine of links and info for the newcomers.
But pls in the future refrain from using 'accusing' language when you don't understand something by presenting it to this board as if I, at purpose, provided wrong information, which is not the case. That doesn't mean I don't make errors, but if detected I correct them or at least acknowledge them if someone else corrects them. That is not the case here.
P-value ------- The requirement of the FDA for 0.02 to be stat. sig was posted in the FDA guidelines and the slides. I don't remember who posted it. You are probably mixing up RATIO and P-VALUE.
MOS 5.6 months 11.1 months 13.1 months 12.1 months
Ratio (p-value) -- .512 (.0286) .539 (.0714) .524 (.0154)
...the study has now translated into a statistically significant extension in overall survival for patients,...
The combined arms with p-value 0.0154 are statistical significant. If your theory would be correct the 1mg/Kg arm with 0.0286 (which is lower then 0.05 that you claim the FDA needs but higher then the 0.02 I said) would have been stat. sig. on its own yet it wasn't. It was almost impossible that an individual arm would have been stat. sig given we know now that the control arm got 25% Bavituximab.
It are the Sept 7th results that are of importance to us and not the conservative FDA filing with 60% SOC improvement. That is because we know NOW, what we did not know at the time, that the sabotage was in the DISADVANTAGE of Bavituximab and that the Spet 7th results did IN NO WAY BENEFIT from any advantage by the sabotage but on the contrary had a disadvantage. So the Sept 7th 2012 data was in practice even better since the control arm got 25% Bavi and that impacts BOTH Bavi arms because they BOTH compare to the control arm. On top of that in SUNRISE we have an n=291/291 vs n=41/40/40 in PII.
In regard to statistical significance, you got a few things wrong. ... Why did you state something so erroneous?
The above shows I am not wrong but you are. Pls do more D&D before writing sentences like the above.
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.
You are either looking at the wrong PII or you misread. The above link is the link to the PPHM PR. The Chicago presentation is in CJ's information section and confirms the PR.
Pls do your D&D because in the above you are confusing the board. I start to wonder if you are working with the combined arm results instead of the Sept 7th results. 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.
You have said repeatedly that Peregrine showed statistical significance in their P2 trial. You have not given a cogent explanation.
As shown above, wrong. Pls do better D&D. Sept 7th 2012 was mentioned as a source (that is again the link above) and the answer was in it. This is common knowledge here on the board too.
I have asked you to explain how you arrived at this conclusion. You have not given a cogent explanation.
Yes I did, you just didn't look into the related details in the docs. I am not going to copy complete PR's in my posts. The links are present.
I also don't take orders very well. Pls refrain from such constructs in the future when you ask for help on this board. I am glad to help, as will many, but don't mistake me for the sheep while I am trying very hard to be the shepherd and not the wolf.
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.
Of course you are entitled to your own views, even if they are wrong. No problem there as long as you don't try to confuse the PPHM board.
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