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AcelRx Pharmaceuticals, Inc. (ACRX) Message Board

  • piper_jefferies_1 piper_jefferies_1 Nov 8, 2013 2:17 PM Flag

    ACRX NDA acceptance and PDUFA date

    Just to clear some things up:

    They submitted NDA on September 27. Using the 60-day period that the FDA has to review and accept or reject; the agency will have to make a decision by November 26 or 27, depending on whether you include the submission date or not.

    Assuming the FDA accepts NDA, ACRX will receive a Prescription Drug User Fee Act date, or PDUFA date, to review the drug/device combo in the third quarter of 2014 or possible earlier in 2014

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    • NDA decision any day now.

    • So how would you play this because it went exponential today on an up grade of a holder in the stock and we know it'll get the NDA designation but the 3rd quarter of 2014 is far away yet here comes Xmas rally. I'm just kicking my #$%$ for not buying at the close yesterday and all those other times when it was lower than that. I don't think this is going to close below $ 7.40 to $7.50. I guess I should be happy I didn't but at $10 and jump in now. I even missed this in the morning waiting for it's usual drop but to no avail. Frustrated with myself and I know this is a winner, damn.

      • 2 Replies to ambiancerecords
      • I WOULD NOT PLAY THIS IF I WERE YOU. The entire management has succesfull experiences in buyouts, so when good news shows up, you could sell BUT you would kick your head against the wall if there was a buyout announcement one week later at 80% premium.

        Sentiment: Strong Buy

      • NDA acceptance is not guaranteed but most likely it will get accepted in this case as the results were outstanding vs morphine. I am long term and will not be touching this for at least a year. you could trade it and buy now and sell once you get a pop for NDA acceptance. or you could buy now and wait for the pop that you will get on a European partnership. regardless, you should see this rising in price into next year on speculation of FDA approval and a European partnership. in addition, the market selloff in biotech and small caps has hit this stock particularly hard. should be at least a $10 stock at this point

 
ACRX
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