Provectus Breakthrough Denial Is Symptom Of a Different Breakthrough at FDA
This article was originally published in RPM Report
Provectus Pharmaceuticals raised a few eyebrows by raising the curtain on FDA’s rejection of its Breakthrough status application for its malignant melanoma drug. By making the letter public, the company shed light on the broader issue of how seriously FDA is taking symptom improvement as a component of clinical meaningfulness in some cancers.
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