Sarepta timeline delayed on muscular dystrophy drug

October 27, 2014 11:39 AM

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Now, the company says the FDA is requiring additional data as part of the submission, including results out to 168 weeks from a mid-stage study of 12 patients. The company reported data out to 144 weeks in July. The FDA is also looking for three-month data from at least 12 to 24 newly exposed patients by the time of submission, according to excerpts from FDA meeting minutes provided by the company.

Now, the company says the FDA is requiring additional data as part of the submission, including results out to 168 weeks from a mid-stage study of 12 patients. The company reported data out to 144 weeks in July. The FDA is also looking for three-month data from at least 12 to 24 newly exposed patien...

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