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Tuesday, 07/25/2017 11:40:21 AM

Tuesday, July 25, 2017 11:40:21 AM

Post# of 464993
FYI...Fast Track designation allows for a more frequent dialogue with the Neurology
Division at FDA on the company's drug development plan, data requirements and
clinical trial design, throughout the drug development and review process,
with the goal of getting important new drugs to patients more rapidly. Through
the Fast Track program, a product may be eligible for priority review at the
time of a New Drug Application (NDA) filing and may also be eligible to submit
completed sections of the NDA on a rolling basis, before the complete
application is submitted.
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