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ContraVir Pharmaceuticals Reaches Agreement with the FDA on the NDA Package for TXL
Feb. 13, 2018 09:00AM PST
Pharmaceutical InvestingContraVir Pharmaceuticals (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the U.S. Food and Drug Administration (FDA) has agreed to allow the company to utilize the 505(b)(2) Regulatory Pathway to streamline the development and registration of TXL™ for the treatment of Chronic Hepatitis B. As quoted …
ContraVir Pharmaceuticals (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the U.S. Food and Drug Administration (FDA) has agreed to allow the company to utilize the 505(b)(2) Regulatory Pathway to streamline the development and registration of TXL™ for the treatment of Chronic Hepatitis B.
As quoted in the press release:
“We are very grateful the FDA supports our pursuit of the 505(b)(2) Regulatory Pathway,” said James Sapirstein, Chief Executive Officer of ContraVir. “This critical feedback will allow us to significantly shorten our non-clinical development program by at least 12-18 months, and will accelerate our clinical program towards registration.”
