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Re: dennisdave post# 598499

Monday, 06/05/2023 8:38:10 AM

Monday, June 05, 2023 8:38:10 AM

Post# of 708873
Someone keeps citing the 21st Century Cares Act as evidence that this can be approved in all solid cancers incorrectly. You need trials period. That all solid cancers talk without trials is just absurd. You can go apply for the RMAT or Break Thru and run some biomarker driven trials or single arm cohorts or even basket trials, but again you must run trials to get approved in other indications. That dude's credibility just goes out the window each time he repeats this nonsense.
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