Michele Garufi, Chief Executive Officer of NicOx, commented, “We remain confident about naproxcinod’s medical value and in the strength of the data we have accumulated in our extensive clinical program. We look forward to hearing further feedback from the FDA. We also continue to work with the EMA in Europe, where naproxcinod was filed for approval in December 2009. NicOx is a well-funded company with more than €138 million in cash at the end of March 2010, no debt, a robust pipeline of nitric oxide-donating New Molecular Entities and a strong network of first-class partnerships, including Merck, Bausch + Lomb and Ferrer.”
The Company will seek to continue discussions with the U.S. Food and Drug Administration (FDA) in the review of the New Drug Application (NDA) for naproxcinod following the May 12 FDA Joint Advisory Committee meeting, and looks forward to receiving the overall evaluation, including the Advisory Committee comments. The European Medicines Agency (EMA) is also currently reviewing the Marketing Authorization Application (MAA) for naproxcinod, which was submitted in December 2009 and validated in January 2010. The Company will evaluate opportunities for regulatory submissions for naproxcinod in other countries.
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