The FDA has granted Rare Pediatric Disease Designation to Ovid Therapeutics’ (NASDAQ:OVID)
OV101 (gaboxadol) for the treatment of Angelman syndrome, a rare
genetic condition characterized by a variety of signs and symptoms,
including delayed development, intellectual disability, speech
impairment, problems with movement and balance, seizures, sleep
disorders and anxiety.
Rare Pediatric Disease Designation provides for
the issuance of a rare pediatric disease priority review voucher
following FDA approval. The voucher can be used for accelerated approval
of a future application or it can be sold to a third party.
With this designation, the company may be eligible to receive a priority review voucher from the FDA.
https://seekingalpha.com/news/3584512-ovid-nabs-rare-pediatric-disease-designation-for-ov101-for-angelman-syndrome
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