Breaking News

PLx Pharma announcedthat two chemistry and manufacturing control, CMC, supplemental New Drug Applications , one for VAZALORE 325 mg and one for VAZALORE 81 mg dose (referred to together as, were submitted to the U.S. Food and Drug Administrationin October for regulatory approval. The 325 mg sNDA provided information on a change in formulation and a new manufacturing site for the currently approved VAZALORE and also contains a bioequivalence clinical study report with the required data and analyses from the recently completed BE study. The submission for the 81 mg dose provided for a new product strength of VAZALORE and builds off the information in the original approved NDA and the recent sNDA submitted for VAZALORE 325 mg. The Company received acknowledgement letters from the FDA, officially confirming the receipt of the submissions and setting the estimated completion date for its reviews for VAZALORE 325 mg and VAZALORE 81 mg for the end of February 2021. If approved, the Company plans to bring both doses of VAZALORE to market in the third quarter of 2021. "We are delighted to have achieved this major milestone for the submissions of our two sNDAs to the FDA earlier than previously announced. This is a significant step for PLx and the millions of patients with vascular disease who can benefit from a novel aspirin therapy. We are highly confident our submissions are supported by strong and compelling data that FDA requires for CMC submissions and we look forward to their review," stated Natasha Giordano, President and Chief Executive Officer of PLx. "I'd also like to thank our teams and our partners for their extraordinary efforts preparing these filings and our shareholders for their support in advancing VAZALORE to regulatory review," concluded Giordano.