Tuesday, March 27, 2018
=Antares Pharma (ATRS) : XYOSTED regulatory update
Antares Pharma receives official minutes from Type A meeting with FDA regarding XYOSTED NDA
Based upon this meeting and the FDA minutes, Antares believes that it does not need to conduct any new clinical studies to support the resubmission. The Company anticipates that the resubmission will include re-analyses of existing data, and address labeling and potential post-approval risk mitigation strategies. The Company anticipates submitting the complete response in the second quarter of this year. Under FDA's policies, thirty days after FDA's receipt of the resubmission, the Agency will determine whether the filing constitutes a complete response that addresses all deficiencies in the CRL and, if so, assign a target action date which the Company expects will be within six months of FDA's receipt of the resubmission.
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