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Re: TomP1 post# 58988

Tuesday, 04/12/2016 8:50:13 AM

Tuesday, April 12, 2016 8:50:13 AM

Post# of 458315
ODD provides incentives during the trials as well as after approval. Even if 3-71 doesn't gain approval(heaven forbid), AVXL still benefits from the designation.

Significant -

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.

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