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The Application was submitted on July 19, 2024, and passed the initial FDA Administrative Review. The FDA informed the Company that the FDA placed the Application on hold pending a complete response to the AIR.
The FDA has informed the Company that the Company has 180 days from the date of the AIR to provide a complete response to the AIR or the FDA will consider the Application withdrawn.
As the Company works to respond to the AIR, the Company, in parallel, will pursue a submission for its active modality with Outside the United States ("OUS") clinical data as it continues to work through the AIR for its semi-active system.
Posted In: MGRM