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Zogenix, Inc. Message Board

  • davidosterhout Apr 1, 2013 9:17 PM Flag

    Has everyone given up?!

    OK team ZGNX. Everyone has really dropped off lately. This is my first time buying into a stock to the level I have with this stock. I took a loan against my 401K and now have 13,800 shares. I do not mind sharing because I am confident Zohydro will be approved! So does anyone want to guess what the outcome will be and when? I will go first... Approval 4/11/2013. Trading will be stopped that AM and resume after the PR from Zogenix. This is justy a wild guess.

    Sentiment: Strong Buy

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    • I have , don't think this will get approval

    • Cramers words of wisdom: "Bulls make money, Bears make money and Hogs get Slaughtered!!

    • I have not given up because the stopp act is still sitting in the house and has no date set in the committee and also april 15 which is so near is the date that oxcotin hits the streets in generic form and i assuming fda is waiting for the fed to make a decision to see if this bill passes and what will happen on april 15 so i just assuming that come april 15 and generic oxy cotin hits streets and the housebill has not gotten any support that they will approve zohydro. That just my opinion and not trying to convince people to buy or sell.

      Sentiment: Strong Buy

    • 1) Any day or time before May 10 ; can not be beyond May 10. May be as soon as today.
      2) It looks like FDA would favor approval if it could decide out of its own free will, but FDA is facing lots of pressure from ENDO and congress. 3) To say abuse-resistant is easy, but to decide on the definition, test procedures and approval standards of abuse-resistant from a regulatory position is not that easy. It needs time to develop and apply this abuse-resistant idea to policies. But some people seem to want to rush the FDA to make a hasty change when FDA itself seems not ready in terms of policies, standards,etc.

    • i expect the decision to be announced anytime this week. ive been through these decisions before and when a company files for a secondary it means the decision is imminent. It is likely Zogenix has ended their discussion with FDA and is awaiting the decision.
      As for a possible halt... the stock will only be halted if the decision is announced during regular market hours. if it is announced premarket or afterhours there is no need for a halt.

      in any case making exact predictions about when and how this decision will unfold is really useless discussion. Its entertaining I agree, but there is simply no way to know what will happen.

      As for me, Ive done quite a bit of due diligence and i expect an approval. I read over the FDA quick minutes of the adcom and it appears that the panel did not base their votes on the data. Rather, they said they voted "no" because the fda should not approve zohydro without tamper resistance and that the FDA needs a more restrictive standard REMS program. The FDA currently does not have requirements for tamper resistance, and the standard REMS is the FDAs problem, not Zogenix's. Therefore, I believe there are simply no grounds for denial here.

      Sentiment: Strong Buy

      • 1 Reply to sumyunguy85
      • 1) I wouldnt read into the secondary too much. Clearly this is not a "typical situation" and there really is no precedent here.
        2) I'm almost positive shares will be halted ahead of a PR from ZGNX, no matter whether its pre- or post- market. This happens all the time. Pre and post markets trades matter too ya know.
        3) You're position here is flawed because you are missing the fact that abuse is a matter of safety. Safety is not just limited to what the drug compound does to the body in terms of adverse effects. In the pain space, safety has come to include societal position as well. It's a reality that we can't depend on our doctors, pharmacies, or even the DEA to curb the rapid growth in opioid abuse in our country (so much that it has literally become an epidemic). At some point, alternative routes need to be explored. The most recently explored has been the use of tamper resistant or abuse deterrent technologies. Have they been effective? The jury is still out. Is this whole situation Zogenix's fault? Of course not. But the FDA has to establish a new position when it comes to its management of the opioid products on the market, both new brands applying for marketing approval and with the opioid products already on the market. To say that Zohydro will be approved because there are "simply no grounds for denial" is very much a stretch.

    • Dude, I am so with you. I feel like I am at a roulette table with all my money on Black. I have invested all my "extra" cash I could find with ZGNX.

      I really hope the FDA gives us a decision soon. I don't know why there has been so much insider buying this past yr if they didn't know something we don't. *shrug*

      GO ZGNX!!!
      LONG 32,500 shares.

      Sentiment: Hold

    • It's 50/50 chance that it will be are not's like you are gambling here..u are not investing ....If i were you...i go buy NAVB, NAVB is better choice than ZGNX.

      Also, ZNGA is another good choice is you buy under 3/share b/cit will launch online casino in June. IT WILL a good home run

    • I have a little over $20K invested in ZGNX and even with the current lull I see some potential with this stock. I have no guesses as to when and if it will get approved. I have always given this stock a 50/50 chance of being approved or a CRL.

      I personally would not dip into my 401K but everyone to there own. I hope that your are correct but several weeks is usually more than 2 but less than a lot. This is the only issue I have with the companies PR because they should have quoted what the FDA told them instead of inferring what they thought the FDA meant.

    • Glad to see someone on this desert island here. I am with you! We should here something positive from the FDA before May.

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