In stun­ning about-face, FDA in­vites Eli Lil­ly to quick­ly re­file block­buster hope­ful baric­i­tinib

Just a few weeks ago Eli Lil­ly $LLY made it clear that the FDA was de­mand­ing a new clin­i­cal study to clar­i­fy the safe­ty pro­file of its would-be rheuma­toid arthri­tis block­buster baric­i­tinib, de­lay­ing any re­sub­mis­sion by at least 18 months and per­haps years.

But this morn­ing the phar­ma gi­ant and its biotech part­ners at In­cyte $IN­CY say they’re fil­ing a new mar­ket­ing pitch in just 5 months in an at­tempt to bull their way to an ap­proval by mid-year.

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