In a regulatory filing, Eagle Pharmaceuticals (EGRX +5.2%) discloses that it expects to resubmit its U.S. marketing application for Ryanodex (dantrolene sodium) for the treatment of exertional heat stroke “shortly.”
The company received a CRL in July 2017 citing the need for an additional clinical trial. In its Q3 earnings press release, it stated that it planned to seek FDA sign-off on the adequacy of data on 41 people who participated in Hajj pilgrimages in 2015, 2018 and 2019. Target enrollment for the Phase 3 study launched in August 2018 was 100. The estimated completion date was August of this year.
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