AcelRx Pharma (ACRX) Reports In-Line Q4 EPS

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Go back to AcelRx Pharma (ACRX) Reports In-Line Q4 EPS

AcelRx Pharma (ACRX) Receives Type A FDA Meeting Minutes and Plans to Resubmit DSUVIA NDA in Q2

March 8, 2018 4:11 PM EST

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced the receipt of the official January 2018 Type A meeting minutes from the U.S. Food and Drug Administration (FDA) relating to AcelRx's DSUVIA New Drug Application (NDA).

At this meeting, AcelRx proposed potential resolutions for the two main points identified in the Complete Response Letter (CRL) received from the FDA in October 2017. These main points were: (1) collect additional data in 50 patients with postoperative pain sufficient to... More