AcelRx Finally Has An AdCom Date. Time For A Run Up? [Seeking Alpha]
AcelRx Pharmaceuticals, Inc. (ACRX)
Last acelrx pharmaceuticals, inc. earnings: 3/16 07:35 am
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US:NASDAQ Investor Relations:
ir.acelrx.com/investor-relations
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Source: Seeking Alpha
Summary Early on Tuesday, September 11, AcelRx Pharmaceuticals (NASDAQ: ACRX ) announced that an FDA Advisory Committee meeting will be held for the company's lead drug candidate Dsuvia on October 12. In so doing, ACRX essentially places Dsuvia's fate in the hands of the Advisory Committee - the FDA will likely echo the AdCom's vote on or before the PDUFA date of November 3. Clinical Status After the unexplained cancellation of last year's AdCom meeting for Dsuvia, the confirmation of an AdCom meeting this year is actually a major milestone for ACRX. With regards to the AdCom itself, I see no reason to believe that Dsuvia will not perform well and receive a strong vote of approval. Although the safety concerns mentioned in the drug's CRL intially created doubt among investors regarding Dsuvia's ultimate potential for approval, the company announced in March that it had conducted a very productive Type A meeting with the FDA. To address the FDA's concerns over max
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