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  • Omeros: This Small-Cap Biotech Stock Makes The Grade  [View article]
    Celgene
    Sep 13, 2015. 04:15 PM | Likes Like |Link to Comment
  • Understanding The Volatility In Esperion Therapeutics  [View article]
    Yes ETC1002 acts upstream, BEFORE statin action.
    Clinical trial shows effect.
    For many if not most, dietary cholesterol is minor to the overall burden.
    Aug 24, 2015. 08:52 PM | 2 Likes Like |Link to Comment
  • Understanding The Volatility In Esperion Therapeutics  [View article]
    You have no understanding of cholesterol biology and biochemistry.
    Cholesterol production is not a simple equilibrium driven process.
    Aug 22, 2015. 07:58 AM | 2 Likes Like |Link to Comment
  • BioMarin: Expect First-Pass Drisapersen Approval  [View article]
    The title of the article read “Expect First-Pass Drisapersen Approval” It would have been nice to explain why I should expect that, beyond a few lines of well-known facts.
    Mar 17, 2015. 08:47 AM | Likes Like |Link to Comment
  • Pharmacyclics: Is A $19 Billion Valuation Reasonable?  [View article]
    So ABBV paid $261.25/share. Well above 230!
    Mar 5, 2015. 10:49 PM | Likes Like |Link to Comment
  • Pharmacyclics: Is A $19 Billion Valuation Reasonable?  [View article]
    No! you wrote "The competition is to be very fierce in the next few years."
    Again look at label and tox!
    PCYC is running several combo studies, so competition running both ways.
    GS4059 has a long way to go before combo clinical.

    By the way I am long both PCYC and GILD.
    I am long GILD for HIV and HepC.
    I am long PCYC for more B cell leukemias (look at all clinical trials) and autoimmune.
    Mar 1, 2015. 05:21 PM | Likes Like |Link to Comment
  • Pharmacyclics: Is A $19 Billion Valuation Reasonable?  [View article]
    How one can claim that Zydelig represents a fierce competition when sales are flat while that of Ibrutinib is still growing. To understand this modest performance look at Zydelig label and tolerability: diarrhea/colitis.

    Ibrutinib works on B cell type of leukemia. At this time 3 types have been approved, more to come.
    Autoimmune disease represent an interesting avenue to further expand the market for this drug.
    Feb 28, 2015. 09:07 PM | Likes Like |Link to Comment
  • Pharmacyclics: Is A $19 Billion Valuation Reasonable?  [View article]
    Again another strange review of PCYC.

    How one can claim that Zydelig represents a fierce competition when sales are flat while that of Ibrutinib is still growing? To understand this modest performance look at Zydelig label and tolerability: diarrhea/colitis.

    Ibrutinib works on B cell type of leukemia. At this time 3 types have been approved, more to come.
    Autoimmune disease represent an interesting avenue to further expand the market for this drug.
    Feb 28, 2015. 06:41 PM | 1 Like Like |Link to Comment
  • Any Pharmacyclics Deal Is Not Likely To Come To Fruition  [View article]
    I find your review of the current Ibrutinib clinical trials rather quick and the idea of dismissing value due to lack of certainty rather uninformed. Value in bio or pharma is necessarily forward looking, yet with some risk

    You will find certainties in US government bonds.
    Feb 26, 2015. 06:12 PM | 2 Likes Like |Link to Comment
  • Celgene: Do The Revlimid Polymorph And Use Patents Matter?  [View article]
    I do not disagree with anything written by the author.

    But I would like to augment it.


    Polymorph are often less stable that crystals:

    1- Chemically, these form sometime decompose to produce impurities, some of these could be toxic or, more often, reduce potency because there is less drug


    2- As indicated polymorph are more soluble, some polymorph, over time, transform to crystals that are less soluble.


    Solubility is very important:


    1- Bioavailability relates to the proportion absorbed in the blood


    2- The rate of dissolution indicates the speed at which the drug gets in the blood. Too fast or too slow may be a problem even if the bioavailability is the same. This leads to toxicities (if too fast) or less efficacy (too slow)


    In general none of the above is a killer. Definitely a core competency of generic manufacturer is formulation of drug product.
    May 5, 2014. 04:01 PM | 1 Like Like |Link to Comment
  • Proof of Olysio + Sovaldi?  [View news story]
    Combo SOF/SIM most cost effective against HepC G1

    http://1.usa.gov/RmNTgN
    Apr 15, 2014. 04:29 PM | Likes Like |Link to Comment
  • Intercept Pharmaceuticals: 6 Different Insiders Have Sold Shares This Year  [View article]
    Dr Karmaswimswami, you seem to suggest overvaluation here.
    You are a medical doctor with a PhD and familiar with hepatic conditions, would you care to suggest the number of NASH patients that could benefit from OCA? And perhaps could you shed some light on the current cost for NASH patient support (since there are no current treatments)?
    Jan 21, 2014. 02:17 PM | 1 Like Like |Link to Comment
  • Summer Street not giving up on Ariad's Iclusig despite suspension  [View news story]
    Here is a quote from the USFDA statement on the issue:

    “Patients who are currently taking Iclusig and responding to the drug and whose health care professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA’s safety investigation continues. FDA will work with the manufacturer on a plan to quickly transition these patients to a program that will allow access under an IND or expanded access registry program”
    So from a patient perspective not all is lost.

    Also from the same USFDA statement we learn that in a Ph1 with patient median duration of 2.7 years, 48% of patient had “experienced serious adverse vascular events”, there are more details in the statement.

    It seems fair to say that in general the toxicity appear to be proportional to duration and dose.

    From a shareholder perspective, this is bleak.
    I was long Ariad.
    Nov 1, 2013. 11:29 AM | Likes Like |Link to Comment
  • Summer Street not giving up on Ariad's Iclusig despite suspension  [View news story]
    Some readers may remember the TYSABRI story; following news of patient deaths the drug distribution was suspended. The story may be a good comparator for timing purpose.

    Here is the TYSABRI time line

    February 28th 2005, the drug commercial distribution was suspended

    July 24th 2006, the drug became available again but with a substantial risk management plan and new label

    So, 17 months.
    TYSABRI is a Biogen drug for MS
    Oct 31, 2013. 04:02 PM | Likes Like |Link to Comment
  • Ariad slides again as FDA details adverse event reports  [View news story]
    Well, I am not sure as to the meaning of the word “principle”.

    The patent (5,521,184) expired on 28may13 and was extended for 586 days under 35 USC 156. The patent is a composition of matter patent or, more plainly said, on the molecular structure and synthesis of the drug active.

    So, no new molecule need to be invented here.

    Other patents have been awarded on formulations and crystal polymorphs. These types of patents are usually recognised as “weak”: Not only difficult to defend in court but can also be formulated around. Generic manufacturer have a lot of expertise here.
    Oct 11, 2013. 09:59 PM | 1 Like Like |Link to Comment
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