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Zalviso NDA resubmission may slip beyond Q1 2015

Sep. 26, 2014 9:19 AM ETTalphera, Inc. (TLPH) StockBy: Douglas W. House, SA News Editor
  • AcelRx Pharmaceuticals (NASDAQ:ACRX) says it is targeting its resubmission of the NDA for Zalviso (sufentanil sublingual tablet system) for Q1 2015. The timing could be delayed, however, depending on the timing of the FDA's review of its response to the CRL and feedback on the proposed bench testing and human factors study.
  • The regulator issued the CRL on July 25, 2014.
  • ACRX is off 16% premarket on moderately high volume.

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