Did Sarepta Need To Tell Investors About Its Vyondys 53 Dispute Resolution Request?
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
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A look back over FDA actions during the past 10 years shows the evolution of its policies on opioids, preemption, off-label promotion and use of real-world evidence.
Formal dispute resolution was key element in four-month turnaround from rejection by US FDA to approval for golodirsen, the second Sarepta DMD drug to clear the agency after appearing to have minimal prospects.
More companies are turning to CDER’s formal appeals process when presented with a review division’s regulatory decision or advice. Even though few appeals are granted in full, many sponsors get valuable clarity on a path forward; some appeals, like that for Amarin’s Vascepa SPA, are turned away at the door.