OPEXA Forum: Community User: rich

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Acer Therapeutics Receives Notice of Allowance of Key US Patent Application Covering EDSIVO(TM) (celiprolol). Notice of allowance of celiprolol method of treatment of vEDS patent application strengthens proprietary position in U.S. until 2038 "the US Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Acer's patent application No. 16/930,208, exclusively licensed from Assistance Publique--H?pitaux de Paris, for claims related to certain methods of treating vascular Ehlers-Danlos syndrome (vEDS) with celiprolol. The allowed patent claims in the application titled, "Method of Providing Celiprolol Therapy to a Patient," include the dosing regimen in Acer's ongoing Phase 3 DiSCOVER (Decentralized Study of Celiprolol on vEDS-related Event Reduction) clinical trial of EDSIVO(TM) (celiprolol) for the treatment of patients with COL3A1-positive vEDS." Acer's patent is expected to be issued in Q4 2022 and expire in 2038. If it receives marketing approval for EDSIVO(TM) after completion of the DiSCOVER trial and NDA resubmission, Acer intends to submit the patent for listing by the FDA in its Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

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Acer Therapeutics Says FDA Has Issued Complete Response Letter Regarding NDA For ACER-001, citing 'the need to inspect a third-party contract packaging manufacturer'; Says 'pharmacokinetics of ACER-001'

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Acer Therapeutics Announces Agreement With FDA On Special Protocol Assessment For Its Phase 3 EDSIVO Trial In Vascular Ehlers-Danlos Syndrome Patients