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photonic5

09/13/18 9:58 AM

#189288 RE: flipper44 #189286

Your insight here is appreciated and your work astounding. Thank you for your time

I believe your points all are validation of Dr. Liau’s overall implication that the longer this trial goes, the better the results will be. I believe process improvements, optimization, and insights continued to benefit patients as the trial proceeded. The question is whether the FDA viewed these as negative and confusing and implemented the hold to avoid additional optimization or changes. We’ll get more insight with final results.

Finally...good luck to investors, but more importantly, good luck to GBM patients. This vaccine still holds the promise of being a monster breakthrough technology in the fight against one of the worst cancers known to man. The scientific community is anxiously awaiting the study results. If this works on GBM, the next advance should be for it to work on all solid tumors.
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sukus

09/13/18 10:08 AM

#189290 RE: flipper44 #189286

Could not thank you enough Flipper. Great posts!
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meirluc

09/13/18 10:18 AM

#189291 RE: flipper44 #189286

Great summary flipper. Looks to me like the correct sequence of events. NWBO may want to get the maximum mileage especially from the last 31 who may be doing just great. We may therefore have to wait till November and a little beyond. Unfortunately plenty of time for the nefarious elements to walk the SP down.
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jammyjames

09/13/18 11:05 AM

#189299 RE: flipper44 #189286

"3. Exwannabe states it's not that clear. He thinks the quote up above meant kinda sorta there was a relationship between undiagnosed and the first 38 enrolled. I disagree. "

I think ex's point was that there were only 16 or 17 patients enrolled about a decade ago before the freeze. So those patient's can't account for the full 38.
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jammyjames

09/13/18 11:13 AM

#189301 RE: flipper44 #189286

There's also a big confounding factor here

the patients with undiagnosed MGMT status are likely to be the ones with less surgical resection as you usually need quite a lot of DNA for bisulphite treatment before MSP or sequencing. Hence these patients probably failed genotyping because of the lack of tumour material. And we know that greater surgical resection is associated with better prognosis
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Evaluate

09/13/18 1:02 PM

#189314 RE: flipper44 #189286

you wrote:

5. So we have three pieces of information that show the first 38 enrolled did not do well.

6. The premise to this, as posited by you, is that they were primarily MGMT unmethylated. We can't prove this but there must be a reason.



Could the White Blood Cell count have something to do with it?

Perhaps the early patients had relatively severely depressed levels of WBC?

And ... perhaps the clinical hold had something to do with WBC levels.
Perhaps the latest patients enrolled, whom may have had superior survival, had good levels of WBC. (so unrelated to any improvement of the DCVax-L formulation etc).
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xoma4578

09/16/18 2:37 AM

#189770 RE: flipper44 #189286

Post 189286 by Flipper.

Thanks.