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Zogenix, Inc. Message Board

  • aicdeftone aicdeftone Dec 14, 2013 1:45 AM Flag

    FDA cannot legally pull Zohydro

    without pulling all other opiates otherwise they are in violation of disrupting a free market. They even stated as much when explaining their decision to approve it against the opinion of the board. Go back and read it.

    Sentiment: Strong Buy

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    • Any guesses on when the Justice Dept will address the attorney generals concerns? That "unknown" is the only thing fueling the shorts. "Unknown" since it's painfully obvious what they'll say when they finally decide to say it. No reversal, go back and read the FDA's statement during approval in regards to ignoring the panel's opinion not to approve it. My guess is before year's end.

      Sentiment: Strong Buy

    • Hydrozo is not good. I think FDA should pull this drug right now

      Sentiment: Strong Sell

    • The other opiates aren't as powerfull as Zohydro, a drug that is every junkie's dream come true.

    • Great point. This was just a scare tactic that is all. The AG had to do this -- but the reality is that the abuse of a few is not fair to take this important product away from millions of patients that need real pain therapy without the side effects. The very fact that this company is ensuring that they are responsibly addressing abuse is a testament to the integrity of ZGNX.

      Sentiment: Strong Buy

    • Straight from Bob Rappaport, a director at the FDA in regards to questions as to why the agency approved Zohydro despite the boards recommendation not to:
      "Punishing this company and this drug because of the sins of the previous developers and their products, from a regulatory standpoint, that's something we CAN'T do." "We are OBLIGATED at the agency to operate within the regulatory framework and that includes providing a level playing field for industry. We don't have a choice by that. IT"S THE LAW."
      shorts and bashers, does this make sense?

      Sentiment: Strong Buy

      • 1 Reply to aicdeftone
      • [Purdue was involved in measures against prescription drug abuse, particularly of Oxycontin. In 2001, Connecticut Attorney General Richard Blumenthal issued a statement urging Purdue to take action regarding abuse of Oxycontin; he did note that, while Purdue seemed sincere, there was little action being taken beyond "cosmetic and symbolic steps."[8] After Purdue announced plans to reformulate the drug, Blumenthal noted that this would take time, and that "Purdue Pharma has a moral, if not legal, obligation to take effective steps now that address addiction and abuse even as it works to reformulate the drug."[9] The company has since implemented a comprehensive program designed to assist in detection of the illegal trafficking and abuse of prescription drugs without compromising patient access to proper pain control.
        In May 2007 the company pleaded guilty to misleading the public about Oxycontin's risk of addiction, and agreed to pay $600 million in one of the largest pharmaceutical settlements in U.S. history. Its president, top lawyer, and former chief medical officer pleaded guilty as individuals to misbranding charges, a criminal violation, and agreed to pay a total of $34.5 million in fines.[10][11] In addition three top executives were charged with a felony and sentenced to 400 hours of community service in drug treatment programs.]

        Some AG admit it was not the drug itself that caused the problem but the actions of the company Prudue. Note that Blumenthal also stated that it "would take time." Well, the AGs can't give others the competitive advantage by letting them continue to market painkillers that are not proven to stop abuse while shutting others out of the markets. This is especially true when the new formation will provide a additional benefit and reduced risk to patients.

    • "Disrupting a free market." We will see exactly if this case takes a precedence over the free markets. The shorts are also increasing their present in this sectors. It also appears that they are trying to put pressure on the FDA decision making process. Chances are they contacted legislators who are clueless about short selling and the free markets. They just allowed a group of short sellers to gain by interfering in the free markets with their negative report.

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