Ob­sE­va im­plodes on warn­ing that the FDA has set up a road­block for its flag­ship drug

Just weeks af­ter scor­ing an ap­proval for its flag­ship drug in Eu­rope, Ob­sE­va has run in­to a reg­u­la­to­ry mael­strom in the US that has evis­cer­at­ed its mar­ket cap and forced it to seek a court-ap­point­ed ad­min­is­tra­tor in Switzer­land while re­struc­tur­ing the com­pa­ny and con­sid­er­ing what “strate­gic op­tions” it might have.

The biotech re­port­ed ear­ly Wednes­day that the FDA has raised is­sues “re­gard­ing de­fi­cien­cies in the New Drug Ap­pli­ca­tion (NDA) for lin­zagolix for uter­ine fi­broids. These re­view is­sues pre­clude dis­cus­sion of la­bel­ing and post-mar­ket­ing com­mit­ments at this time. “

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