Thursday, November 17, 2022 6:28:25 PM
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/
"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/
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- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/01/2025 09:04:38 PM
