Yes, the FDA did just slap down PTC’s Duchenne MD drug for the third time
Whatever last shred of hope remained that PTC could turn things around and win a miracle approval at the FDA for their Duchenne muscular dystrophy drug ataluren ended with a terse statement Wednesday morning noting that the agency has rejected their marketing application.
According to PTC, the FDA has demanded more data from a new clinical study, along with some CMC input along with additional info that the biotech says it is in the process of providing.
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