Cowen’s healthcare analyst Boris Peaker weighed in today with a few insights on AcelRx Pharmaceuticals Inc (NASDAQ:ACRX), after the company provided a regulatory update on Zalviso, which is designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The FDA division restated a request for clinical data to complement other data AcelRx has developed to assess the overall performance of the Zalviso device.

Peaker noted, “We do not believe the choice of a surgical model will have a meaningful impact on the outcome as the primary endpoint for this study is the device error rate rather than efficacy. In addition, we believe the study will likely enroll between 100 and 400 patients though ACRX will confirm the protocol with the FDA before initiating it in 1Q16. Based on the time required for the prior Phase III studies, we expect that topline data for this trial will be available around year-end 2016.” The analyst rates Acelrx shares a Market Perform.

According to, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Boris Peaker has a total average return of 21.4% and a 46% success rate. Peaker is ranked #106 out of 3772 analysts.