The recent controversy surrounding Replimune Group’s melanoma therapy has quickly become a proxy battle over the U.S. Food and Drug Administration itself. In the face of complex and sometimes conflicting clinical evidence, reasonable people can disagree about the merits of a particular therapy. But focusing on whether this one drug should be approved risks missing the more important issue. For innovators, the central question is not whether the FDA has strict standards. It is whether the agency applies its standards consistently.
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