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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