The first big hur­dle on the Cel­gene CVR ar­rives to­day. Can Bris­tol My­ers clear a low bar in the mid­dle of a pan­dem­ic?

Can the FDA ap­prove a close­ly-watched drug in the mid­dle of a pan­dem­ic?

We’ll find out to­day just how se­vere­ly the pan­dem­ic has af­fect­ed the FDA. A bevy of an­a­lysts have been fol­low­ing Bris­tol My­ers Squibb’s progress with ozan­i­mod and most are giv­ing this drug high chances of suc­cess — pro­vid­ed there’s no last-minute hitch to get hung up on.

Ozan­i­mod — or Zeposia, as it will be called if it makes it to mar­ket — was fa­mous­ly kicked back to Cel­gene af­ter the biotech lame­ly failed to put to­geth­er an ap­pli­ca­tion worth in-depth con­sid­er­a­tion at the FDA. Cel­gene then took an­oth­er 2 years to prep for an FDA-wor­thy ap­pli­ca­tion, which Bris­tol My­ers picked up in the ex­pec­ta­tion that it could dri­ve the mul­ti­ple scle­ro­sis drug over the fin­ish line.

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