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Fly News Breaks for August 29, 2017
ACOR
Aug 29, 2017 | 08:33 EDT
Leerink analyst Paul Matteis notes that Acorda Therapeutics announced that it has received a refusal to file letter for its CVT-30 NDA. The analyst says this comes as "a very significant surprise," given strong phase 3 data, 505b2 application and the device's decade long development. FDA questions are not related to clinical/safety data, but instead are conveyed as two asks regarding manufacturing, he points out. The analyst reiterates a Market Perform rating on the shares.
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