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m_yossi

m_yossi
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  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    The Pump Stopper,

    Contrave is "safe" ? ? ?

    Please read:

    http://bit.ly/1q8nfnk

    http://bit.ly/1q8ngHQ
    Jun 7 07:21 PM | 1 Like Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    Jim,

    Victoza is an injectable drug!

    For Diabetes you need to use 1.2 mg to 1.8 mg per day,
    BUT for weight loss you'll need 3 mg ! ! !

    Author failed to mention that!
    Jun 7 07:04 PM | 5 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    phemale60,

    It's about Google Trends.

    Just compare BELVIQ and Qsymia in the US during 2014.
    Jun 7 06:49 PM | 3 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    HT,

    http://bit.ly/1pQXQBc

    http://bit.ly/1pQXOta

    It's an issue only regarding rats.
    Jun 7 06:42 PM | 1 Like Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    Jim,

    If you are asking me the whole rat issue was a non-issue from the very beginning.
    It was a mistake of the FDA.

    The details as far as I recall:

    • Tumors developed only in one kind of mammals - Rats which are known to easily develop tumors (many times irrelevant to many other mammals including humans).

    • Tumors were (statistically) significantly higher than the control group only in the highest dose group (about 70 times the therapeutic dose).

    • Tumors were (statistically) significantly higher than the control group only when all kinds of tumors were combined together (even malignant and benign in one group!) - NOT DONE imo!

    • As far as I can recall the experts' committee included mainly Endocrinologists.
    • I think only one Statistician and one Cardiologist were in the room (not including Arena's experts).

    It's absurd!

    Endocrinologists decided regarding Valvulopathy and regarding Carcinogenicity...

    They are CLUELESS about these issues!

    They needed at-least one Oncologist, at-least one Veterinarian, and most important - at-least two Histopathologists ! ! !
    They also needed more Statisticians and more Cardiologists IMHO!

    While checking the tumors once again (after the CRL) it turned out that results were even better than what Arena's experts thought!

    Please note that the FDA did receive ALL the data.

    Since it was pre-clinical Tox data, and since the FDA gave them OK to move forward to human clinical trials - Arena was sure that there is NO Carcinogenicity issue regarding the FDA (since they've asked for many more results regarding Valvulopathy but NONE regarding Carcinogenicity! Even not more animals’ studies!).

    Now, since it's almost impossible to sue the FDA - frustrated investors sued Arena.

    BTW, even if they did something wrong about 4 years ago, it's totally irrelevant for now.
    If this issue was solved and closed then it's finished;
    And IF something is still ongoing who said that court will decide that Arena is guilty? Pump Stopper?

    Bottom line is that BELVIQ was approved by the FDA!
    Jun 7 04:20 PM | 7 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    The Pump Stopper,

    Your target of $1.25 (-80%) means market cap is LESS than cash + TaiGen value!

    What about NOLs value?

    So BELVIQ + the amazing pipeline and very strong IP worth zero IYO?

    Dear Pump Stopper,

    BELVIQ is going to be a blockbuster for sure ! ! !

    ARNA is a VERY Strong BUY at the moment ! ! !

    (Easy double next 5 months IMHO)

    BTW, better cover ASAP...
    Jun 7 01:10 PM | 5 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    The Pump Stopper,

    OREX? ? ? - The new VVUS?

    Two generics and weak IP?

    What about the debt?
    Jun 6 03:30 PM | 11 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    The Pump Stopper,

    IF Contrave is so potent and safe then why it is NOT approved until now ? ? ?
    (Unlike Qsymia and BELVIQ...)

    Are you sure it will be approved?

    The main issue now is that they've recruited much older patients and high percentage of T2DM patients to the last trial.

    That is why they've reached interim so quick!

    This way the control group receiving placebo had enough cardiovascular events in a VERY short time.

    The problem is that since "interim" occurred so quick, the real drug group did NOT receive Contrave for long enough time to get the adverse effects!

    The interim results of the requested study are NOT good enough for safety study (it was too short!).

    OREX has only interim results and the FDA should NOT accept that - they should complete the requested trial before approval!

    We have LESS info regarding safety compared to last study since it's INTERIM results!
    (Too short time on drug!)

    Capisce?
    Jun 6 03:27 PM | 13 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    The Pump Stopper,

    Contrave is safe ? ? ?

    Naltrexone (Contrave):

    Please read what Jim from IV wrote:

    "I'm an investor in arena and mostly a lurker on this board, but I have some thoughts about the patient acceptance of Contrave ( if approved ) vis a vis Belviq, which I haven't seen addressed. Patients taking naltrexone present a serious problem in the event they need narcotic analgesia. Naltrexone has a relatively long half life. I think it would be incumbent upon the physician prescribing Contrave to inform the patient that in the event of injury or the need for emergency surgery that narcotics will be ineffective for several days after the last dose of Contrave. I suspect that this information would cause some second thoughts in both the prescriber and the patient especially when considering a long term medication. The reports to WebMD of what the experience was like with a long bone fracture, other surgical emergency , MI , GABG etc while taking Contrave may be interesting. Compared with the benign side effect profile of Belviq I can't fathom Contrave becoming the market leader".

    WOW ! ! !
    Jun 6 03:21 PM | 15 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    The Pump Stopper,

    Contrave is safe ? ? ?

    Bupropion (Contrave):

    http://bit.ly/1olcu1w

    http://bit.ly/1olcvCM

    http://bit.ly/1olcu1E

    http://bit.ly/1olcu1G

    http://bit.ly/1olcui0
    Jun 6 03:15 PM | 12 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    The Pump Stopper,

    Lorc/Phen is going to "kill" Contrave!

    Study ends July and docs can prescribe it already.

    Looking for amazing results:

    95% responders (above 5% weight loss);
    70% will have above 10% weight loss (in just 12 weeks);
    50% above 12% weight loss;
    and 25% above 15% weight loss.

    1. It is possible according to anecdotal results;
    according to Phen alone results (it should be better);
    and according to Fen/Phen weight loss results.

    2. If so then Lorc/Phen for 3 months is BETTER (AND safer) than Qsymia AND Contrave for 12 months ! ! !

    3. You'll get LESS side effects than adding the side effects of Lorc and Phen together.

    4. Secondary endpoints such as HbA1c and dyslipidemia improvement are going to be much much better than Phen alone!
    Jun 6 03:13 PM | 16 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    The Pump Stopper,

    Qsymia is dead!

    http://bit.ly/SgT01D

    http://bit.ly/SgT01H
    Jun 6 03:05 PM | 13 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    The Pump Stopper,

    List of short term and long term catalysts:

    During next 6 months:

    Lorc/Phen study results,

    Mexico and Canada approvals,

    script increase x 4 (at-least IMHO),

    TaiGen will pop,

    partnering agreements regarding Australia, New Zealand and Israel,

    2-3 celebs recommending BELVIQ (I hope and believe).


    Next 12 months:

    Smoking cessation study results,

    70%-80% insurance coverage (about 25% more than today),

    Korea and Brazil,

    filing for approval in another 6 countries,

    EU re-submission,

    vanity market.


    Next 18 months:

    Patients on anti-psychotic drugs,

    CAMELLIA-TIMI 61 first year interim results (important regarding T2DM patients),

    3-4 pipeline phase II studies’ results!

    Taiwan,

    At-least one more pre-clinical project will complete phase I,

    BELVIQ once a day new formulation will be approved.


    Next 24 months:

    ROW approval (at-least 70% of countries),

    PPAs, and royalties moving up from 31.5% towards 36%.

    Partnering at-least two more new drug candidates during phase III (ARNA has a VERY promising pipeline).
    Jun 6 03:00 PM | 17 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    The Pump Stopper,

    Why shorts are covering ? ? ?

    http://bit.ly/1whb2Bb
    Jun 6 02:58 PM | 12 Likes Like |Link to Comment
  • Arena Pharmaceuticals: Strong Sell On Multiple Red Flags [View article]
    The Pump Stopper,

    Contrave ? ? ?

    Contrave affects liver, kidneys, AND HEART much more than Lorc!

    It is LESS potent than BELVIQ regarding (BELVIQ’s) Responders, and BELVIQ is much safer.

    Regarding T2DM patients BELVIQ is much better even if we talk about completers (not about Responders).

    Blood pressure was lower than baseline but higher than the control group after 52 weeks (despite weight loss!).

    Weight loss after 9 months treatment is very similar to Lorc (even when including non-responders).

    Dropout rate was double than control group (because of adverse effects) unlike BELVIQ that dropout rates were similar in the placebo and real drug groups.

    We have NO data regarding two years.

    MACE rate was almost double and safety study was not completed (until now).
    Two Generics = Weak IP (just like Qsymia...); and it is LESS potent than the dead Qsymia...
    Jun 6 02:54 PM | 16 Likes Like |Link to Comment
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