Acorda Therapeutics Inc. shares dropped 26% Tuesday on news that the Food and Drug Administration won’t let it file for approval of its Parkinson’s disease treatment.

The FDA’s decision, in the form of a refusal to file letter, means that Acorda’s ACOR, -26.95% drug application wasn’t complete enough for the regulator to review it—an embarrassing development for a drug company.

The refusal to file is “surprising, puzzling, disconcerting” and a “very significant surprise,” said Leerink analyst Paul Matteis, adding that “even after speaking with the company, the [refusal to file] is mysterious to us, and we expect the stock to be under pressure until opacity is lifted.”

Related: Acorda Therapeutics shares crater 26% premarket after FDA rejects application for Parkinson’s treatment

The FDA’s refusal to file letter had to do with the date that the manufacturing site for the drug, Inbrija, would be ready for the regulator’s inspection and a question about the drug master production record, which ensures uniformity between batches of the drug.

The FDA also asked for more information when the drug application is resubmitted, though it was not the basis for the refusal to file letter, Acorda said.

The regulator didn’t ask for more efficacy or safety studies, which would set the timeline for approval back even further.

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Very informative
05-03 04:23 by Liam
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