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Sarepta Shares Tank 44% On Negative FDA Outlook For Eteplirsen

On Thursday shares of Sarepta Therapeutics (SRPT) tanked by 44% after the FDA posted a negative briefing for the company's drug eteplirsen. The drug eteplirsen is being developed to treat patients with a rare muscle wasting disorder known as Duchenne Muscular Dystrophy -- DMD. The FDA noted that it was willing to review the drug, but was very reserved in the manner they spoke about Eteplirsen. This quote sheds some light:

"Although FDA is prepared to be flexible with respect to a devastating illness with no treatment options, we cannot approve drugs for which substantial evidence of effectiveness has not been established"

As observed above, the FDA has a major problem with the way the trial has established...


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