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  • The IBB Likely To Move Higher Along With These Biotechs With Catalysts Upcoming [View article]
    All Mann has been "guiding" for a long time about speaking with partners which I take as a bunch of noise, because he has not delivered on it. While I believe Afrezza will see approval, I also believe REMS will be attached. Additionally, Mnkd's company structure is a mess, especially on the financial end with all the convertibles.. Be careful here with this one as I believe an investment in MNKD is extremely risky and perhaps even unwise. GL!
    Jun 2 09:19 AM | 3 Likes Like |Link to Comment
  • Orexigen's Weight Loss Drug Will Be Approved Soon And Will Lead Market - Here Is Why [View article]
    SPA was revoked as $AMRN did not meet requirements nor did they ever PR that they met the requirements.
    May 28 01:20 PM | 1 Like Like |Link to Comment
  • Orexigen's Weight Loss Drug Will Be Approved Soon And Will Lead Market - Here Is Why [View article]
    Yes, I have done the research. Off label subs are a very small part of doctor presciptions, and even smaller with Obama care that subsidizes both patients and insurance companies, which is why we are seeing more of these formulations coming to the market -- to take advantage of Obama Care. This is also in great part why biotech has been flying since 2009.
    May 28 12:24 PM | Likes Like |Link to Comment
  • Orexigen's Weight Loss Drug Will Be Approved Soon And Will Lead Market - Here Is Why [View article]
    because im not a licensed broker dealer under series 7 and 57. If I do not use a disclaimer, and someone buys or sells and loses, they can sue. It's called legalities -- please look that up, thanks!
    May 28 12:22 PM | Likes Like |Link to Comment
  • Orexigen's Weight Loss Drug Will Be Approved Soon And Will Lead Market - Here Is Why [View article]
    and EU approval for Contrave in an open market means? Belviq and QSYMIA have no shot at that now. Orex has said the interim data meets the SPA, if they are lying, they can be sued. If it does meet, it gets approved.
    May 28 12:21 PM | Likes Like |Link to Comment
  • Orexigen's Weight Loss Drug Will Be Approved Soon And Will Lead Market - Here Is Why [View article]
    there are risks with every drug. 4k per 1 million is very low. There are more adverse effects with viagara and SSRI's.

    Every drug out there has side effects. The FDA determines this risk on cases. 4k is low. If this was a factor, this would be part of the SPA, and it's not.
    May 28 12:19 PM | Likes Like |Link to Comment
  • Orexigen's Weight Loss Drug Will Be Approved Soon And Will Lead Market - Here Is Why [View article]
    point by point.

    1. If SPA is met, the FDA is required to approve -- please learn what a SPA is. REMS would be mentioned in the SPA as agreed to clinical testing. since a SPA was granted, if met, there will be no REMS.

    2. VVUS and ARNA do not have positive data in any way showing their solutions do not cause either birth defects or cardio issues, which is why EU said no to VVUS and Arena withdrew their app for Belviq

    3. Jury awarded damaged are not a fine, please get your facts right. While a jury awarded 9m in damages, the case is being appealed, so until that process is complete, we do not know if there is real wrong-doing here. Furthermore, based on this logic, every large pharma should be sold short as BMY, GSK and others have paid billions in damages -- part of big pharma

    4. QSYMIA and Contrave are already made up of generic drugs which can be off labeled prescribed but are done so infrequently. both of the drugs have their own patents in combo similar to Belviq in terms of time frame.

    Belviq has no hope of EU approval, where as Contrave does because of the light study which equates to an open market. Please get the general facts right. Failure to do so could create big monetary losses if short!
    May 28 12:18 PM | 3 Likes Like |Link to Comment
  • Orexigen's Weight Loss Drug Will Be Approved Soon And Will Lead Market - Here Is Why [View article]
    correct, I submitted the changes to reflect this. My point was that it's complete as far as what is needed to meet the SPA agreement for approval. My bad, this was not intentional
    May 28 12:10 PM | 1 Like Like |Link to Comment
  • Orexigen's Weight Loss Drug Will Be Approved Soon And Will Lead Market - Here Is Why [View article]
    SPA designation required that Orex showed positive interim data from Light study. Since company has complied with these requirements, the FDA is bound by their own reg to approve. Are you aware of this? Also, according to your view, Belviq would be worthless since doctors can off label prescribe a contrave combo now. and since Contrave is more efficacious and safer.

    The real fact is that off label prescriptions are mostly reserved for patients that do not have the needed insurance to cover the cost of the more expensive Contrave when approved. Obama care affords this insurance to patients, and also enriches big pharma, which is why Pozen and others are in fact formulating solutions readily available to the public. In Pozen's case, their PA is available over the counter, yet big pharma is glad to shell Pozen significant money for the product. Conclusion - most patients are not self educated nor have the time to get self educated. Off label subs are a small part of most doctor prescriptions, Futhermore, if your point is followed to the fullest, investors should dump Arena. Is this the case?
    May 28 12:08 PM | 2 Likes Like |Link to Comment
  • Orexigen Will Run: Here's Why [View article]
    Yes, I stated my comment about compound Pharmas was off base, but the FDA has been clamping down on them
    May 27 09:44 PM | Likes Like |Link to Comment
  • Orexigen Will Run: Here's Why [View article]
    Finally, the above comment from someone who makes some sense. See, now what is the REAL purpose of Obama care? I bet you know Doc -- to enrich insurance companies via government subsidies -- like big oil. This is why Pozen, Orexigen and many others exist -- they know there is a large supported market out there. Additionally, Contrave is likely to be approved in Europe where the others have either failed or in Arena's case, withdrew app because they knew they would fail. This brings a huge market into play for Orexigen. These Arena people need to stop comparing the 2 drugs. Arena has greater value in its earlier pipeline, which could make it a legit mid cap pharma in time. Orexigen is likely to never become more than a small cap unless they come up with more stuff. Therefore, as a company, Arena has far more potential, but Orexigen clearly has the better weight loss drug.
    May 27 09:42 PM | Likes Like |Link to Comment
  • Orexigen Will Run: Here's Why [View article]
    oh please, this is stock and money, get on the sympathy wagon on the appropriate board! My dad was 100 pounds overweight and he changed his diet and lost it. He did not need any legal "speed" to do it.
    May 27 09:37 PM | Likes Like |Link to Comment
  • Orexigen Will Run: Here's Why [View article]
    Oh, I'm sorry, that's right, Arena withdrew the EMA app. Still equates to the same, not approved in EU, whereas because of CV data, Contrave is likely to be approved there. Stop comparing both companies. The fact is that Contrave has much higher potential than Belviq and Qsymia, regardless of whether patients can get it off labeled prescribed. U need to read up on Obama care. btw, I did mis speak about compound pharmas. Contraves 2 ingredients are not compounded anywhere.

    I will let the market decide. I agree with this author here. Orex has very good upside run up potential.
    May 27 09:35 PM | Likes Like |Link to Comment
  • Orexigen Will Run: Here's Why [View article]
    heh? Is Belviq approved in Europe? If so, may I see the link? Additionally, wasnt Belviq shot down in Europe? This equates to a failure, same as any company that gets a CRL. It's possible in the future Belviq wins future EMA approval, but as of right now, Belviq is not EMA approved and has been rejected by that organization.

    "Their drug?" Pozen's solution can be bought over the counter, so consumers don't even need a prescription, yet many analysts are bullish on it and see a nice market.

    Get off the Belviq kick, Arena has better stuff going for it with their earlier pipeline, << this is where the real value is, not in Belviq. I like Arena, but not Belviq so much.

    scripts this quarter for Belviq freebies are up 300% btw.
    May 27 09:32 PM | Likes Like |Link to Comment
  • Orexigen Will Run: Here's Why [View article]
    I did not delete anything Doc, I do not have that power, I only write for SA, I do not edit. I'm sorry SA deleted a post, Please post again, thanks!
    May 27 09:06 PM | Likes Like |Link to Comment
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