Af­ter 2 damn­ing CRLs and 3 de­nied dis­pute-res­o­lu­tion re­quests, an ail­ing, one-time uni­corn has on­ly a glim­mer of hope left with the FDA

Back in Sep­tem­ber 2017, the FDA is­sued its first com­plete re­sponse let­ter (CRL) for Intar­cia Ther­a­peu­tics’ lead, type 2 di­a­betes drug, call­ing on the com­pa­ny — the FDA now says — to ad­dress ex­ten­sive clin­i­cal de­fi­cien­cies, and de­vice and prod­uct qual­i­ty-re­lat­ed is­sues.

At the time of the CRL, how­ev­er, the com­pa­ny said in a state­ment that it did not ex­pect to be or­dered to con­duct “new piv­otal tri­als or any long lead-time CMC ac­tiv­i­ties.”

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