NetworkNewsBreaks – Apricus Biosciences, Inc. (APRI) Intends to Re-submit Vitaros NDA Following FDA Feedback; Shares Sink
Apricus Biosciences (NASDAQ: APRI) dropped 12% in mid-morning trade after announcing that it has received feedback from the FDA regarding the previously announced Type B Meeting request to confirm Apricus’ strategy for addressing the deficiencies contained in the 2008 CRL. The FDA’s feedback suggested additional analysis of existing clinical and non-clinical data, though it did not indicate that new clinical studies would be required for re-submission. Importantly, the FDA determined that Vitaros, under current regulations, is now considered a drug-device combination. Apricus said it believes there is “a viable regulatory pathway for resubmission of the Vitaros NDA in the U.S.”…
