Third time the charm? An­a­lyst says a mar­ket­ing de­ci­sion is “im­mi­nent” for Sarep­ta’s Duchenne drug eteplirsen

Every­thing that hap­pens at Sarep­ta – re­al or imag­ined – is grounds for de­bate and ram­pant spec­u­la­tion on Twit­ter. So it’s no sur­prise that when Baird an­a­lyst Bri­an Sko­r­ney is­sued a note late last week say­ing that the FDA’s de­ci­sion on Sarep­ta’s con­tro­ver­sial drug eteplirsen is “im­mi­nent,” the on­line ker­fuf­fle that fol­lowed in­clud­ed plen­ty of taunts, tantrums and tears.

Some nec­es­sary back­ground: Sarep­ta’s NDA for eteplirsen has fa­mous­ly been de­layed twice. The first de­lay came af­ter FDA in­sid­ers round­ly crit­i­cized the drug for fail­ing to show signs of ef­fi­ca­cy. The sec­ond came with their sec­ond sal­vo that took apart Sarep­ta’s coun­ter­at­tack on a point-by-point ba­sis. Both re­views cas­ti­gat­ed the biotech for fail­ing to heed re­peat­ed ad­vice on run­ning a big­ger, bet­ter study. And then there was an ex­pert pan­el vote against an ap­proval, based on the agency’s over­whelm­ing­ly neg­a­tive view.

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