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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