Amicus chief John Crowley is snubbed at the FDA on his latest pitch for quick drug review. He'll be back, but analyst sees big delay
Amicus CEO John Crowley’s latest pitch to put a new drug on a pathway to accelerated approval has run into a hurdle at the FDA. Crowley acknowledged in a statement out early Monday that a meeting with regulators failed to generate much enthusiasm for a quick review of AT-GAA (ATB200/AT2221) based on what they’ve seen so far in a Phase I/II trial.
But Crowley $FOLD, who recently overcame the odds in winning a reversal of the FDA’s decision to initially reject Galafold, isn’t about to stop now. The company says it plans to keep pressing, just as it did earlier this summer after the EMA also held up a stop sign to a conditional approval.
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