The FDA has granted Sofpironium Bromide a standard review (as expected), and confirmed that an advisory committee meeting will not be required. Advisory committees are sometimes convened to assist in the review of complex applications.
In the meantime, an FDA mid-cycle review is due to be completed in Q1, which means we will get further feedback on the progress of the FDA review.
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The FDA has granted Sofpironium Bromide a standard review (as...
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