Complete Response Letter for ITCA 650 (exenatide implant) for the treatment of type 2 diabetes.- Intarcia Therapeutics.
Intarcia Therapeutics, Inc., announced that the 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 activities in order to satisfy the requirements of the FDA. The Company received clear and constructive guidance from the Agency regarding manufacturing aspects of the CRL and is on a clear path to move forward.
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