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.
You may also be interested in...
Coronavirus Notebook: Fauci Calls For Restraint In Disclosing Early Data; Bipartisan Lawmakers Want Warp Speed Audit
Dispatches from a world turned upside down also include the conditional approval of remdesivir in South Korea.
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.