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In an interview Wednesday, he said he was baffled by the FDA's decision to approve the drug under a special mechanism known as an accelerated approval, which will require Biogen to confirm the drug works by running a follow-up trial.
"The FDA, in using the accelerated approval mechanism, they could not endorse any evidence of demonstrable clinical benefit. That's what their press release said in so many words. That seems illogical to me," he said. Perlmutter told STAT News that he resigned from the panel"due to this ruling by the FDA without further discussion with our advisory committee."
The FDA isn't required to follow the recommendation of its advisory committees, but typically does so.
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