$LJPC Monday is Day 74 in the NDA acceptance Timeline. Artesunate has both Orphan Drug and BTD status. “The benefits of Breakthrough Therapy designation include eligibility for Priority Review and Rolling Review, plus an organizational commitment involving the FDA’s senior managers to provide more intensive guidance regarding the development program.” Although assignment of a PDUFA date for May is possible, it does seem unusual to wait this amount of time and hopefully the outcome becomes clear this week.
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