US FDA Granted Fast Track Designation to Medicure’s MC-1 for PNPO deficiency

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US FDA granted Fast Track designation to Medicure’s MC-1 for seizures associated with PNPO deficiency. Also received Rare Pediatric Disease Designation and ODD by US FDA; ODD by EMA
Medicure is in launch phase of P-III study, daily dose of MC-1 will be administered to approx. 10 PNPO patients in US and Australia
If FDA approves NDA for MC-1, Medicure will receive Priority Review voucher which can be redeemed or sold

Ref: Medicure | Image: Medicure

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