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Re: jbainseky post# 274365

Tuesday, 10/04/2016 7:27:43 AM

Tuesday, October 04, 2016 7:27:43 AM

Post# of 347009
jbainseky, I have the RAW PPHM TEXT to support what I claim. What you just posted isn't even CLOSE to what King said and full of speculation.

About:

No, you are jumping to the wrong conclusion when you believe he suspected a portion of the patients caused the triggering.



While we are deeply disappointed by this early outcome from the SUNRISE trial, we plan to take a deliberate and detailed approach in reviewing and verifying all available data from the trial in order to understand what subgroups or other patient characteristics may have impacted the performance of the study.



How much more clear could this have been said?

They are going to look at "all available data from the trial" which proved they didn't yet "in order to understand what subgroups or other patient characteristics may have impacted the performance"

Why are they going to look at all available data? In order to UNDERSTAND what SUB-GROUP or PATIENTS CHARACTERISTIC (tow way to say: NOT ALL PATIENTS) have impacted the performance.

Say WHO? Apparently ONLY YOU because the nature of a 1st look-in is that you look only to a PORTION of the Median Table. So apparently your statement is wrong per definition.

It was the futility of the entire patient population that caused the triggering.


And the word futility is used completely wrong in the above sentence. The advice was that it would be FUTILE to further enrol patients NOT that the patient population was futile.

And where do we know this from.

King (as any biopharm would do) went in to analyze the data and found a nugget of positive data. on the 10th, we will learn how big that nugget is, but we know it isn't across the entire patient population.


CEO Kings last PR statement said nothing anymore about sub-groups. And even if they would have removed patients that had 3rd line treatment then that was with UPFRONT agreement of the FAD.

Remember, last comments on my posts on this topic were that Sunrise data was to be buried and never heard from again (something with dust, I don't remember exactly who said it). Now PPHM PRs that they have statistical significance and that kind of "buried comments" would sound ridiculous in the light of this new evolution and know the findings must be based on nuggets while PPHM in the same PR writes explicitly that they have collected THOUSANDS of patients samples to come to their conclusion.

I hope we at least agree that you cannot come to any biomarker conclusions on patient samples that where in the biomarker set and NOT in the statistical significant overall survivor set otherwise the word CORRELATE would not be at its place.

And since there were only about 582 patients and the FDA needs 5000 samples and PPHM claims that they have a biomarker correlation based on thousand of samples analysys I also hope we agree they didn't take these thousands of samples of a NUGGET size sub-group of patients because those poor people would have any blood left!

So I have certainly plenty of grounds from my statements but I find NON, not even a small one, in the texts that supports your IMO.




Peregrine Pharmaceuticals the Microsoft of Biotechnology! All In My Opinion. I am not advising anything, nor accusing anyone.

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