2 annotations
If the FDA fails to approve the requested modification by the Prescription Drug User Fee Act (“PDUFA”) date of December 12, 2021, our third party contract manufacturer may not be able to supply us with sufficient ANNOVERA to adequately supply the market or generate sufficient revenue to meet the covenants under the Financing Agreement.
(No comment added)
10-Q
2021 Q3
12 Nov 21
There can be no assurance that such a modification will be approved by the FDA. If the FDA fails to approve the requested modification by the PDUFA date of December 12, 2021, our third party contract manufacturer may not be able to supply us with sufficient ANNOVERA to adequately supply the market or generate sufficient revenue to meet the revenue covenants under the Financing Agreement.
(No comment added)
10-Q
2021 Q3
12 Nov 21
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