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PDUFA set to July 7, 2021 for Chimerix's(CMRX) Brincidofovir as a Medical Countermeasure for Smallpox

Source Link:
https://ir.chimerix.com/news-releases/news-release-details/chimerix-announces-fda-acceptance-new-drug-application

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Additional Information

Additional Relevant Details Brincidofovir, an investigational therapy, is a nucleotide analog lipid-conjugate that has demonstrated antiviral activity as a medical countermeasure against smallpox under the FDA’s Animal Efficacy Rule, which allows for testing of investigational drugs in animal models to support effectiveness in diseases which are not ethical or feasible to study in humans.
Chimerix has developed BCV as a potential medical countermeasure for smallpox under an ongoing collaboration and funding provided by the Biomedical Advanced Research and Development Authority (BARDA).
https://ir.chimerix....
Additional Relevant Details Update on Feb 25, 2021: PDUFA initially expected April 7, 2021; the Prescription Drug User Fee Act (PDUFA) goal date for review of brincidofovir (BCV) as a medical countermeasure for smallpox has been extended three months to July 7, 2021.
https://ir.chimerix....
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Catalyst Date
Occurred on:
Jun 04, 2021
Occurred Source:
https://ir.chimerix.com/news-releases/news-release-details/chimerix-receives-us-food-and-drug-administration-approval
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Related Keywords Brincidofovir, Smallpox
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