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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