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learningcurve2020

12/11/24 10:33 PM

#736952 RE: tunnelvisionofplenty #736897

I doubt DCVAX falls under "Highly personalized".  That's likely reserved for therapies targeted to a patients genetic makeup. DNA, Crispr for rare disease.  


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Doc logic

12/12/24 11:54 AM

#737082 RE: tunnelvisionofplenty #736897

tunnelvisionofplenty,

Common sense is not so common these days so glad to see you using some as well as keeping an eye on the right places to look for clues as to what is going on behind the scenes. Reminds me of the due diligence that led to the uncovering of the 2015 annual report from Fraunhofer that indicated the Phase 3 L trial was only enrolled to the point statistically necessary. That comment helped explain why 17 SOC/placebo patients were left out or kept out by obvious regulator intervention. This halt, which ended up lowering the powering of the trial, would have put the regulators in a bad spot if the halt and under enrollment was not for a good reason. That good reason of course was confirmed by JAMA Oncology peer review. Best wishes.