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Re: TomP1 post# 58985

Tuesday, 04/12/2016 8:36:09 AM

Tuesday, April 12, 2016 8:36:09 AM

Post# of 458250
ODD provides significant incentives.

Therefore, obtaining it is 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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