Santhera's clinical data are in, but NDA delayed 4-6 months by third party manufacturer
Santhera Pharmaceuticals finished submitting the clinical portion of its rolling NDA yesterday, but the Swiss biotech’s regulatory ambitions are now pushed back four to six months because of manufacturing hurdles.
The biotech said its third-party contract manufacturer needs up to half a year to get ready for FDA inspections, Santhera disclosed Wednesday.
Santhera started submitting documents to the FDA in March for its drug vamorolone, which it hopes will get the green light for treating Duchenne muscular dystrophy. CEO Dario Eklund told Endpoints News earlier this month that the company was hoping for a PDUFA date in Q1 or Q2 of next year.
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