After facing a 16-month sojourn during Covid to overcome a stunning CRL, little Enzyvant says it's back on track — expects marketing decision later this year
Back in late 2019, Enzyvant CEO Rachelle Jacques was shocked when the FDA issued a CRL for its therapy to treat ultra-rare cases of pediatric congenital athymia — a condition marked by extreme immune deficiency and an early death. Like a lot of older, bigger organizations, Jacques discovered that regulators were not eager to OK the CMC setup at Enzyvant, though she told me at the time that she believed that with no demands for new clinical data, she felt that it could all be resolved in “a few months.”
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