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Heron Therapeutics, Inc. Message Board

  • crewrider61 crewrider61 Mar 8, 2013 8:04 AM Flag

    Has the company answered or corrected all issues within the CRL?

    Can anyone tell me, with references, if this company has actaully addressed all the issues? I'd hate to witness another DSCO.

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    • yes

    • You are late getting in, they are going to run it back up today, just look at the level 2 ask side... you missed the boat, but there is still money to be made if you buy quick this morning.

      Sentiment: Strong Buy

    • Hello? Anyone? How about just one reference, to just one issue, being resolved to FDA satisfaction. I really do want to buy, but have found no assurances of reconsiliation of issues except for the syring.

      • 3 Replies to crewrider61
      • Crewrider, you can find all the answers to your questions on the companies website and via SEC filings. APF530 will receive approval this time around IMO and the company has been hiring about 10 key personal to get this product moving.

        APPA is way oversold right now and has experienced a full technical correction. This stock does trade on the OTC markets which I personally hate due to the manipulation that can be done in this market. However, that being said, if you don't freak out and give up your shares like they want retail to do, no one will be able to hold the share price down on approval.

      • At the FDA’s request, A.P. Pharma conducted a trial that compared moxifloxacin, which is known to cause QT interval prolongation, with subcutaneous APF530 and IV high-dose granisetron. On March 26, 2012 A.P. Pharma, Inc. issued a press release announcing positive safety results. This study was a four arm cross over design conducted in 56 healthy patients that compared the effects of four treatments:

        twice the proposed therapeutic dose of APF530 (1 g subcutaneous, 20 mg granisetron)
        five times the therapeutic dose of granisetron (50 μg/kg IV over 3 minutes)
        400 mg oral moxifloxacin, and
        placebo (0.9% normal saline)


        The primary endpoint was to show that APF530 has no clinically meaningful effect on QT interval prolongation as defined by QTc

      • There was no question on the efficacy. Some minor issues raised by FDA and company spent 2-3 years resolving that issue. Company is 100% confident on the Approval this time and has been doing key recruitment for the successful launch of the product immediately after Approval.
        All the analysts believe this will get Approval.

        Well, i am confident !

        Sentiment: Strong Buy

 
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