BioMarin says the FDA game clock now ticking on their blockbuster hopeful pegvaliase
BioMarin $BMRN has taken a big step toward a final FDA decision on its latest rare disease drug to reach regulators. The agency accepted the biotech’s application for pegvaliase, handed it a priority review to speed the process, and then likely shoved it back down the line with some special requests on CMC.
Officially, the PDUFA date for the drug is February 28, but the new CMC information demanded by regulators will most likely cause a delay of a few months, says the company, putting a decision back to the end of May.
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