Avenue Therapeutics Inc

NASDAQ:ATXI   12:15:06 PM EDT
3.86
+0.02 (+0.52%)
Products

Avenue Therapeutics Receives Complete Response Letter From The FDA For Iv Tramadol

Published: 10/12/2020 10:42 GMT
Avenue Therapeutics Inc (ATXI) - Avenue Therapeutics Receives Complete Response Letter From the FDA for Iv Tramadol.
Avenue - Crl Stated That Although Pivotal Phase 3 Trials Showed Statistically Significant Outcomes, FDA Cannot Approve Application in Present Form.
Avenue Therapeutics Inc - Crl Stated That Iv Tramadol is Not Safe for Intended Patient Population.
Avenue Therapeutics Inc - Crl Stated That FDA Requires Adequate Terminal Sterilization Validation Prior to NDA Approval Planned for Later This Quarter.
Avenue Therapeutics Inc - Other Than Potential Safety Concern, FDA Did Not Identify a Safety Signal in Avenue's Clinical Development Program.