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Re: 1990 post# 67

Tuesday, 01/16/2018 12:00:41 PM

Tuesday, January 16, 2018 12:00:41 PM

Post# of 468
Encouraging Update on Orphan drug designation:Based on the above, the FDA was unable to grant us our request. We intend to respond promptly and provide the missing information. There is no assurance that we will successfully obtain orphan drug designation for Tourette Syndrome, although we believe that we can provide adequate data to address all issues raised by the FDA.

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