Intar­cia may fi­nal­ly get its post-CRL re­view, al­though FDA points to Covid and an­oth­er hear­ing as tak­ing pri­or­i­ty

Intar­cia Ther­a­peu­tics, once val­ued at more than $5 bil­lion and at­tract­ing in­vestors like the Bill & Melin­da Gates Foun­da­tion, is now tus­sling with the FDA’s drug ad­vi­sors over a last-ditch hear­ing to dis­cuss the agency’s sec­ond re­jec­tion of the com­pa­ny’s lead type 2 di­a­betes drug since 2017.

Back in De­cem­ber, Intar­cia’s lawyer sent a let­ter to the FDA re­quest­ing that the agency set up a hear­ing to dis­cuss this com­plete re­sponse let­ter, which laid out clin­i­cal de­fi­cien­cies and de­vice and prod­uct qual­i­ty-re­lat­ed is­sues for the drug, known as IT­CA 650.

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