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Forest Laboratories Inc. Message Board

frankposting 19 posts  |  Last Activity: Jun 11, 2014 11:58 AM Member since: Feb 27, 2006
  • frankposting by frankposting Jun 11, 2014 11:58 AM Flag

    Seven green-days in a row approaches 50 DEMA, $1.54, without any public news.

  • frankposting by frankposting Jun 7, 2014 2:23 PM Flag

    On iHub, someone published estimated MACE # from REDUCED-IT based on different incident rate with V 4 g/d (with 5.2% for placebo as revealed in FDA's AdCom briefing). 967 MACE events will trigger an interim analysis. Summary as follows:

    Rate w V 4g/d____Total MACE Event # (V + Placebo)
    2.60%__________967 as of 7/28/1026
    3.38%__________967 as of 4/16/2016
    4.42%__________967 as of 12/27/2015

  • Reply to

    One Person's TG

    by frankposting Jun 1, 2014 9:09 PM
    frankposting frankposting Jun 1, 2014 11:01 PM Flag

    mm/yy___V g/d_____TG___LDL___HDL
    May/13_____0______327__104___51 (w/o V)
    Sep/13_____2______520__210___37 (starting V 2g/d)
    Dec/13_____3______303__130___54 (switching V from 2 to 3 g/d)
    Mar/14_____1______194___95___44 (switching V from 3 to 1 g/d)
    May/14_____1______89___119___37 (maintaining V 1 g/d)
    (on low dose statin since 2003)

  • frankposting by frankposting Jun 1, 2014 9:09 PM Flag

    mm/yy___V g/d_____TG
    May/13_____0______327
    Sep/13_____2______520
    Dec/13_____3______303
    Mar/14_____1______194
    May/14_____1______89

  • Reply to

    We run the show

    by patchen76 May 22, 2014 11:40 AM
    frankposting frankposting May 23, 2014 12:28 PM Flag

    PTX's Profile: "Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, develops, manufactures, markets, and sells branded and generic pharmaceutical products. The company’s product include CEDAX, a oral cephalosporin used for the treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis, middle ear infection due to haemophilus influenza, or streptococcus pyogene; REZIRA, ZUTRIPRO, and VITUZ, which are oral solutions for the relief of cough and nasal congestion; and OMECLAMOX-PAK to treat patients with H.pylori infection and duodenal ulcer disease. Its products also comprise SILENOR, a prescription medicine used to treat insomnia characterized by difficulty with sleep maintenance; KHEDEZLA, a prescription medicine for the treatment of major depressive disorder; and NATROBA, a prescription medicine used to treat head lice. In addition, the company offers various generic pharmaceutical products in the areas of nutritional supplements, analgesics, urinary tract, women’s health, pre-natal vitamins, and dental health, as well as allergy, respiratory, iron deficiency, nephrology, and pain management. It serves drug wholesalers, retail drug stores, mass merchandisers, and grocery store pharmacies in the United States." PTX itself looks like a grocery store, actually.

    With estimated $220M sales in 2015, in fact, the expect EPS is -$0.06 (still in RED). Seemingly, low margin products still dominate their product portfolio. They need more high margin products. However, remember that the acquisition of Treximet costs about $300M debt to PTX.

  • Reply to

    What Is Needham Meeting For

    by frankposting May 21, 2014 11:41 AM
    frankposting frankposting May 22, 2014 1:02 PM Flag

    The ANDA filer is one of the biggest generic drugs maker in the world with very successful track records. FDA has accepted the ANDA -- I.e., the bioequivalence has been already established -- just waiting the court.

  • Reply to

    What Is Needham Meeting For

    by frankposting May 21, 2014 11:41 AM
    frankposting frankposting May 22, 2014 12:27 PM Flag

    The meeting is ongoing. The PPS is fluctuating. The closing price will give up a hint: how is the meeting. Anyway, the chance of a successive Treximet is slim. A challenger already filed an ANDA against the Patent 7332183, and they employed "mixture" against "multilayer" to avoid any "infringement".

  • Reply to

    What Is Needham Meeting For

    by frankposting May 21, 2014 11:41 AM
    frankposting frankposting May 21, 2014 12:57 PM Flag

    It is obvious now that Needham is behind the tradings (yesterday, today and tomorrow).

  • Reply to

    What Is Needham Meeting For

    by frankposting May 21, 2014 11:41 AM
    frankposting frankposting May 21, 2014 12:43 PM Flag

    Without enough collateral will be counted (smoking lounge).

  • frankposting by frankposting May 21, 2014 11:41 AM Flag

    My two cents:

    1) $300M debt facility in order to be acquiring Treximet on time. The problem is that PTX doesn't have enough assets to be collateral. BTW, a 12% annual interest means $36M annual payment for interest alone.

    2) Working Capital for commercialization of two products (Treximet and Silenor, 70 Reps): the best is a $100M by selling shares, but I doubt PTX has the power to support that.

    Seemingly, PTX still has a glimmer of chance by extend the patent protection of Treximet to 2025. It is about the POZN patent 7332183 "Multilayer dosage forms containing NSAIDs and triptans." POZN won a patent lawsuit on Treximet, a long time ago. It was about the fixed dose combination of Treximet and expiring 2017. Fixed Dose Combination is a kind of strong patents. But Patent 7332183 is a formulation patent. Generally, formulation patent is a kind of weak patents.

    Just my two cents.

  • Reply to

    something is up

    by caseykasem67 May 20, 2014 11:38 AM
    frankposting frankposting May 20, 2014 1:20 PM Flag

    Red day is not in favor to real sellers -- volume tells.

    BTW, a strong stock is never afraid of short. "No shares for short," means PTX is afraid of short. But shorts will keep coming later. Dogs cannot get rid of fleas.

  • Reply to

    something is up

    by caseykasem67 May 20, 2014 11:38 AM
    frankposting frankposting May 20, 2014 1:02 PM Flag

    Brokerages: "No PTX shares available to short for today." Someone needs to sell shares but don't want to borrow to shorts -- real sellers.

  • Reply to

    Needham: Go Big or Go Home

    by frankposting May 18, 2014 3:46 PM
    frankposting frankposting May 18, 2014 9:05 PM Flag

    The patent you are talking about is the patent 7332183 "Multilayer dosage forms containing NSAIDs and triptans." The ANDA challengers are prepared well to overturn it by their new formulations. The "line extensions" are only on the paper not on the court.

  • Reply to

    Needham: Go Big or Go Home

    by frankposting May 18, 2014 3:46 PM
    frankposting frankposting May 18, 2014 4:41 PM Flag

    By the way, generic Treximet will definitely enter the market in 2017. Such that, there will be only two full years, 2015 and 2016, for PTX's Treximet sales. The $250M debt plus AG&S expense exchange for about $250M sales. Where is Doug Drysdale's calculator?

  • frankposting by frankposting May 18, 2014 3:46 PM Flag

    PPS of PTX recently moves like crazy based on Needham's analysis.

    In fact, Needham's note is well balanced "Go Big or Go Home."

    The good news is that Treximet will bring $80M+ annual sales to PTX. Two bad news are: 1) $250M debt, and 2) expensive marketing infrastructure (70 Reps in CNS field). No details on the structure of $250M debt. In general, this kind of sizeable debt could drag PTX into the water later. The proposed marketing infrastructure may cost PTX expending $80M annually.

    I have to say that the picture is not so rosy. "Go Big" or "Go Home"? We will see.

  • The primary endpoint of REDUCE-IT (RI) is MACE (major adverse cardiac event, including heart attack, stroke, cardiovascular surgery, hospitalized angina). In OCT 2013, FDA’s estimate of MACE rate in RI population was 5.2%. The rate should go up gradually in patients with placebo (due to high-triglyceride progressing) and go down gradually in patients with Vascepa 4g/d (due to treatment effect proven by ANCHOR). The RI protocol requires the size of 8,000 patients with high triglyceride. MACE cases target 1,726 to distinct placebo from treatment by statistical significance, and an interim analysis will happen as MACE reached 976 cases.

    Counting on the size of 6,400, the annual total MACE cases is expected to be 333, based on 5.2% rate. RI started in Nov 2011, and the size gradually reached 6,400 in Dec 2013. Assuming, conservatively, there were 350 cases MACE occurred in RI prior to the end of 2013, thus there will be 683 MACE cases accumulated at the end of 2014, and 1,016 accumulated cases at the end of 2015. Therefore, an interim analysis of RI would be occurring in late 2015.

    However, deaths may change the timetable. In ANCHOR Study (702 patients in total), there were four CVE in two patients (including one death caused by MI) with placebo, one CVE with Vascepa 2 g/d, and 0 CVE with Vascepa 4 g/d, in a 12 Week timeframe. Converting to annual death rate, it was 0.6% (a point estimate, not reliable). Whenever, death number can distinct the two arms (placebo and Vascepa) with statistical significance, FDA will terminate RI and announce the conclusion.

  • Reply to

    Where We Have Been

    by frankposting Apr 13, 2014 8:44 PM
    frankposting frankposting Apr 13, 2014 11:18 PM Flag

    The above study was done way after the AdCom (actually in Jan 2014)

    I am a calm guy. Never "ALL IN". And I employ trading Options. There are always "bottoms" and "peaks," and I never put my chances into one basket.

    Anyway, appreciate your concerns -- hopefully, you can make some real money than just bashing with empty hands.

  • Reply to

    Where We Have Been

    by frankposting Apr 13, 2014 8:44 PM
    frankposting frankposting Apr 13, 2014 8:50 PM Flag

    The primary endpoint of REDUCE-IT (RI) is MACE (major adverse cardiac event, including heart attack, stroke, cardiovascular surgery, hospitalized angina). In OCT 2013, FDA’s estimate of MACE rate in RI population was 5.2%. The rate should go up gradually in patients with placebo (due to high-triglyceride progressing) and go down gradually in patients with Vascepa 4g/d (due to treatment effect proven by ANCHOR). The RI protocol requires the size of 8,000 patients with high triglyceride. MACE cases target 1,726 to distinct placebo from treatment by statistical significance, and an interim analysis will happen as MACE reached 976 cases.

    Counting on the size of 6,400, the annual total MACE cases is expected to be 333, based on 5.2% rate. RI started in Nov 2011, and the size gradually reached 6,400 in Dec 2013. Assuming, conservatively, there were 350 cases MACE occurred in RI prior to the end of 2013, thus there will be 683 MACE cases accumulated at the end of 2014, and 1,016 accumulated cases at the end of 2015. Therefore, an interim analysis of RI would be occurring in late 2015.

    However, deaths may change the timetable. In ANCHOR Study (702 patients in total), there were four CVE in two patients (including one death caused by MI) with placebo, one CVE with Vascepa 2 g/d, and 0 CVE with Vascepa 4 g/d, in a 12 Week timeframe. Converting to annual death rate, it was 0.6% (a point estimate, not reliable). Whenever, death number can distinct the two arms (placebo and Vascepa) with statistical significance, FDA will terminate RI and announce the conclusion.

  • frankposting by frankposting Apr 13, 2014 8:44 PM Flag

    Since many new comers here. It is worth to pick up some old researches in this board to show people how deep we have been reached. In this post, I would like to use ACHOR data to show the dynamics of a successive REDUCE-IT.
    Scissor-Type Dynamics

    Serum Triglyceride vs Time, ANCHOR Study

    _____________|_______________________*____*
    _____________|__________________*
    _____________|_____________*
    _____________|________*
    _____________#____*
    ____#____#___*
    #___*____*___|
    *____________|
    _____________|
    _____________|
    _____________|___#
    _____________|
    _____________|
    _____________|
    _____________|
    _____________|________#____#____#____#____#
    Screening (6W)_|_Randomized Treatment (12 Weeks)

    * Serum Triglyceride Level with Placebo (N = 227)
    # Serum Triglyceride Level with Vascepa 4 g/d (N = 226)
    | vertical bar division of screening phase and treatment phase

    All ANCHOR patients are statins takers. The placebo data demonstrated that high triglycerides keep progressing, about 100 mg/dL increment per year averagely, beyond statins’ control. Vascepa 4 g/d data demonstrated a rapid reduction of triglyceride, about 20% averagely, in the first four weeks, then triglyceride keep gradually declining thereafter.
    REDUCED-IT and ANCHOR are in the same population
    The placebo data of ANCHOR Study revealed that triglyceride keep elevating, about 100 mg/dL per year in a linear pace averagely, in patients with mixed dyslipidemia and residually high serum triglyceride levels (200-499 mg/dL). The patients supposed to be in REDUCE-IT for 4-6 years. Therefore, triglyceride in most patients with placebo in REDUCE-IT will shoot up above 500 mg/dL. Even though “FDA stated that it no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL” (I believe that FDA will change their tune soon), they already recognized that serum triglyceride greater than 500 mg/dL causing greater cardiovascular risks. Therefore, no doubt MACE (major cardiac event) keep elevating in REDUCE-IT patients with placebo.
    BTW, in ANCHOR (702 patients in total), there were four CVE in two patients (including one death caused by MI) with placebo, one CVE with Vascepa 2 g/d, and 0 CVE with Vascepa 4 g/d, in a 12 Week timeframe.

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