Late this afternoon the FDA two major decisions. Per a press release from Intarcia;
“Intarcia Therapeutics, Inc., a privately held biopharmaceutical company committed to developing innovative therapies to enhance treatment and prevention outcomes in serious chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for ITCA 650 (exenatide implant) for the treatment of type 2 diabetes. The Company looks forward to meeting with the FDA and working closely together on next steps. Intarcia does not anticipate the need to conduct new pivotal trials or any long lead-time CMC . . .
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