FDA review raises some serious questions for Puma, but shares rocket up on positive notes
Puma Biotechnology will face some tough questions from regulators during Wednesday’s long-awaited panel review for its experimental cancer drug neratinib.
Not only did the FDA review, out this morning, raise pointed questions about the many changes that were made to Puma’s study for early-stage ERBB2-positive breast cancer, it also highlighted — as expected — the high rate of serious diarrhea experienced by patients in the study.
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