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  • pharmaman58 pharmaman58 May 3, 2013 11:38 AM Flag

    diabetic nephropathy IND

    For anybody that missed,it. QCOR had two INDs going--ALS and DN.
    DN was called out in the press release but not mentioned in the conference call.
    Both of these are game changers.

    Sentiment: Strong Buy

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    • I agree this will confirm the 1952 data if indeed ACTHAR has efficacy or not
      and if so many doctors were lying when they said trial and error

    • I know ALS is lou Gehrig's but what is DN

      Sentiment: Strong Buy

      • 3 Replies to longs_will_be_rewarded
      • The below is copied from clinicalkeyDOTcom--one of my favorite sources for medical info. In my opinion, this IND is more likely and more important than ALS in terms of revenue, but it will not bring an extension of orphan drug status due to the large population of patients suffering from DN.

        Same drill as other Acthar prescriptions--there is a certain percentage of DN patients that fail existing therapies.

        Diabetic nephropathy is a clinical syndrome characterized by albuminuria, hypertension, and progressive renal insufficiency
        Approx. 20-30% of patients with diabetes (type 1 and type 2) develop nephropathy
        The earliest clinical manifestation is the presence of small but abnormal levels of albumin in the urine (microalbuminuria)
        Microalbuminuria generally precedes overt proteinuria by 5-10 years. Once proteinuria is detected, renal function gradually deteriorates over 10-15 years
        Diabetic nephropathy may result in end-stage renal disease (ESRD) requiring dialysis or kidney transplantation. Diabetes has become the most common cause of ESRD in the US and Europe
        Considerably fewer people with type 2 diabetes progress to ESRD
        Microalbuminuria is a risk factor for premature coronary artery disease in diabetics
        Coexisting hypertension accelerates the development of renal failure

        Sentiment: Strong Buy

      • facepalm

      • in the title? diabetic nephropathy?

    • QCOR has tons of "proven" potential. But for those paying attention, the DN & ALS possibilities are equivalent to having "free" call options on these potential game-changers! These call are NOT built into the current price of the stock, which makes the current share price even more attractive.
      Tremendous value at these levels.

      Sentiment: Strong Buy

    • worth knowing.

    • Thanks again for reminding us, this should eventually cause a ruckus.

    • ALS would be huge

      • 1 Reply to phi349
      • Phi, ALS would (IF) be huge for a few reasons:
        1. No meaningful current therapies (1) and that ONLY extends life by an average of 2 months.
        2. Death sentence and pure torture progression from mid-stage on is 100% prognosis with death from disease complications a certainty.
        3. Small population, but because no available treatment could easily become a world-wide population for Acthar. I believe US stats are 2500 new cases per year (but Google ALS statistics for details). Could be an 80% or more coverage once proven and most likely a multi-vial and continuous use scenario. Using 2000 patients incrementing each year (layering in year after year) and say 8 vials per patient per year even this small population would dwarf current usage results for Questcor...WITH NO CURRENT COMPETITION.
        4. All this makes ALS (IF successful) a PERFECT CANDIDATE FOR ANOTHER 10 YEARS OF ORPHAN STATUS PROTECTIONS...Questcor has ALREADY FILED THE ACTHAR FOR ALS ORPHAN APPLICATION WITH THE FDA. Reasonably bullish move at this stage of clinical research.
        5. Acthar for ALS, (again IF successful) would not only be a medical and financial game changer for Questcor, but a MEDIA GAME CHANGER AS WELL. The publicity that would surround success in this area would virtually guarantee much greater awareness for Acthar in the other indications it currently serves, both within the medical and patient communities.
        6. NET-NET---Acthar for ALS success would have a massive impact on Questcor's stock price immediately at the point of results of clinical trials (even pending final FDA Approval which would give it another surge because that conclusion would be likely given the ALS Rx scenario currently established). Independent of other +/- results this alone could be worth well over $100 boost in share price for reasons cited above. So it is NOT, nor should it be, materially reflected in current share price and not likely until first clinical indications available to public.

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