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Re: scottsmith post# 59244

Friday, 04/15/2016 11:24:34 AM

Friday, April 15, 2016 11:24:34 AM

Post# of 458465
Any FDA designation that speeds the approval process and cuts costs is significant and should be described as such in the PR. Most companies realize this.

FDA Orphan Drug Designation is evaluated for drugs from all classes that are intended for the treatment of rare diseases, defined as diseases affecting fewer than 200,000 people in the United States. The designation provides sponsors with development and commercial incentives, including seven years of market exclusivity in the U.S., prioritized consultation by FDA on clinical studies and certain exemptions from or reductions in regulatory fees.

AVXL closed down a whopping .05 the day of the hit piece.

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