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Zogenix, Inc. (ZGNX) Message Board

caty_ceaser 10 posts  |  Last Activity: Jul 13, 2014 5:49 PM Member since: Aug 10, 2012
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  • Reply to

    Zohydro has exclusivity until Oct. 25, 1016

    by tdappello Jul 13, 2014 11:41 AM
    caty_ceaser caty_ceaser Jul 13, 2014 5:49 PM Flag

    bitesr - "BUT both of those exclusionary rights are not relevant to Purdue."

    Why do you make this claim? Doesn't exclusivity mean exclusivity. Why would Perdue be considered special?

  • Reply to

    Nothing but Psychological!

    by eleventotwo Jul 9, 2014 10:12 AM
    caty_ceaser caty_ceaser Jul 9, 2014 1:59 PM Flag

    Portly, remember who ran the clinical trials and owns the data required for approval without someone else running trials. The data ownership = value.

  • caty_ceaser caty_ceaser Jun 28, 2014 7:02 AM Flag

    Well said.

  • caty_ceaser caty_ceaser Jun 27, 2014 10:20 PM Flag

    This state choose to ignore the directions of the judge and decided to impede the sale of a single drug ignoring the larger drug class as a whole. This state is trying to only stop Zohydro, not protect its citizens.

  • caty_ceaser caty_ceaser Jun 27, 2014 1:12 PM Flag

    Purdue messed up.
    - They tried mis-informing politicians and abuse groups and even got the Advisory Panel to dis-approve.
    - They tried a low-ball buy-out. (They ignored the market exclusitivity value of Zohydro.)
    - They then flamed/stirred the fear of Zohydro trying to get it pulled by the FDA.
    - They recognized their drug could not be approved with just an ADA application so they submitted it as an NDA. Their hope now is an ADT formula creates enough political pressure for their false NDA to be accepted.

    By accepting the Purdue application as an NDA would set a precident not previously defined. Zogenix would then file suit to protect their market exclusitivity right and which would stall the NDA from being approved until resolved in the courts. By that time, Zogenix would have their ADT version available and Purdue would still loose.

    The mis-info fear Purdue promoted to discourage Zohydro approval would even be applied to their drug which contains twice as much hydrocodone as Zohydro with no deterrance to oral abuse which is the primary abuse method.

    Zohydro's market exclusitivity will make ZGNX a premium buy-out candidate once the Purdue NDA is finally
    shot down.

  • Reply to

    Payback

    by caty_ceaser Jun 5, 2014 5:03 PM
    caty_ceaser caty_ceaser Jun 5, 2014 6:52 PM Flag

    The attacks already have been intense. I've never seen the level of attack Z has withstood. A denial of the Purdue NDA based upon the reasons they hurled at Zohydro seems a reasonable first move by the FDA since the Purdue ADT solution provides such poor benefits with double hydrocodone amounts.

    Sentiment: Strong Buy

  • caty_ceaser by caty_ceaser Jun 5, 2014 5:03 PM Flag

    Once the Altius ADT technology is deployed for the ER version of Zohydro, which would secure/extend the Zogenix "hydrocodone only" patent protection, I would like to see Zogenix use the same technology to develop and IR version of hydrocodone which could allow the FDA to force the removal of Mylan, Purdue, etc IR versions containing an APAP. That would make Mylan and Purdue regret their attack on Zogenix.

    Sentiment: Strong Buy

  • caty_ceaser caty_ceaser May 8, 2014 1:15 PM Flag

    Purdue has screwed the pooch. By waging war against Zohydro, they have created focus on the amount of hydrocodone in a single pill. The Purdue pills contain more hydrocodone than Zohydro since they are designed for a longer 24 Hr extended release than a 12 hr Zohydro. Abusers could take multiple Purdue pills (oral abuse is the primary method of abuse) as easily as ant other pill.

    Zogenix currently has pure hydrocodone market exclusivity granted by the FDA for a couple more years.
    Even if the politicians could force a ban on Zogenix, and request priority on the Purdue 24 hr version, the focus on the amount of drug in a single pill will be used to delay any FDA approval of Purdue until Zogenix can get an anti-deterrent version of Zohydro available. Zohydro is design for a 12 hr extended release. An immediate release burst from even a flawed 12 hr pill is much safer than an immediate release burst from a flawed 24 hr Purdue pill. It short, the FDA will likely want additional data from Purdue from multiple compromised versions of their pill. I would want to see that information.

    Purdue is just noise at this point to me.

  • Reply to

    Roll Call

    by papetebmd May 1, 2014 10:09 AM
    caty_ceaser caty_ceaser May 1, 2014 12:16 PM Flag

    Been on-board 2+ years. Still have shares from Day 1 and now longer than ever.

    It appears to me this has not been about stealing shares since they are not letting ZGNX price run-up and then crashing the price, but rather just trying to prevent any ZGNX traction at all. It appears all about market share to me.

    Purdue, Mylan, and TEVA are desparate to keep the new guy from getting any steam which would cuts their their revenue streams. They act just like a drug-cartel. It has been frustrating/interesting to watch/endure through their Plan A (FDA Advisory disapproval), Plan B (Misinfo hype/scare and impending other Big Pharma plans), Plan C (Congress action), and Plan D (State actions.) Who know what they will try next.

    Gotta hand it to Z though, they have fought some battles which would have taken out some other companies.

    Fortunately for me/longs, they have been working with the FDA instead of trying to push something through like big Parma has done previously. It is unbelievable to me that the FDA is taking actions to assist Z.

  • caty_ceaser by caty_ceaser Apr 25, 2014 2:16 PM Flag

    Been in this since Jan 12. Bought going up, bought going down, bought gowing up, bought going down. I've bought just to buy, but I've not had to sell. My truck, train are now full. I am now waiting for the train to depart. I just never expected to see these numbers again.

ZGNX
1.60-0.08(-4.76%)Jul 24 3:59 PMEDT

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