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Dr Bala

11/17/22 6:09 PM

#534475 RE: dennisdave #534473

The walls are closing in. He is moving the goal posts.
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survivor1x

11/17/22 6:28 PM

#534491 RE: dennisdave #534473

MIC DROP - FDA approves drugs all the time based on just single Arm studies without a control group for improvements much less than survival benefit at 5 years. The fact that we have so many patients alive at 5 years (real GBM patients, the new definition) when most doctors know how unlikely this is in real life. Below is an example, I can post countless others. So stop your yapping.

"The approval itself was based on a single-arm study showing an overall response rate of 31.7% in 106 ovarian cancer patients who’d received between one to three previous systemic treatments. Researchers saw five patients achieve a complete response and a median duration of response of 6.9 months."

https://endpts.com/fda-bestows-accelerated-approval-on-immunogens-ovarian-cancer-drug-with-confirmatory-answer-coming-soon/