Am­i­cus ex­ecs get back up smil­ing af­ter be­ing scuffed again by lat­est set­back

Am­i­cus $FOLD is con­tin­u­ing its se­ries of painful prat­falls as the biotech re­peat­ed­ly trips its way to­ward what ex­ec­u­tive chair­man John Crow­ley con­tin­ues to see as an easy layup at the FDA.

Un­der the light cloak of a Fri­day evening news drop, Am­i­cus re­vealed that the FDA had yet again de­layed an ap­proval de­ci­sion need­ed for AT-GAA — their treat­ment for Pompe dis­ease — af­ter they were un­able to com­plete a man­u­fac­tur­ing in­spec­tion in Chi­na. Covid lock­downs have been play­ing hell with in­spec­tions in the mas­sive Asian mar­ket.

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