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Zalicus Inc. Message Board

scistats 125 posts  |  Last Activity: Jan 13, 2015 7:58 PM Member since: Apr 5, 2009
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  • Coming soon.

    Sentiment: Strong Buy

  • Reply to

    scitats you moron

    by jq_dt Nov 15, 2014 11:51 AM
    scistats scistats Nov 18, 2014 2:35 AM Flag

    Go back to my post directing you to an online sample size calculator and a reference about stroke and sample size. Do the math, and get back to us with the details.
    Athersys is struggling to make ends meet with this underpowered study.
    They actually need a dramatically larger sample size to cut through the variation common to stroke trials.
    And no, I am not interested in odds ratios comparing different measures (Rankin etc.) of the same outcome. All I want is what they have defined as the primary outcome measure to be met so that we can prove success. To do this, I urge them to over-enroll.

  • scistats by scistats Nov 16, 2014 5:04 PM Flag

    It is estimated that nearly 23,400 new cases of primary malignant brain and central nervous system (CNS) tumors will be diagnosed in the United States in 2014; of those, approximately 2,240 will be diagnosed in children ages 0 to 14 years and 540 will be diagnosed in adolescents ages 15 to 19 years.

    Brain tumors are the leading cause of death from solid tumor cancers in children; brain and CNS tumors make up approximately 21 percent of all childhood cancers. The incidence rate of brain and CNS cancers in children has been relatively stable since the mid-1980s, but the death rate has dropped over this period.

    The causes of most brain and CNS cancers are not known. However, factors that may increase the risk of developing certain types of brain tumors include exposure to radiation, exposure to vinyl chloride, and having certain genetic syndromes. There are no screening tests for brain and CNS cancers. Standard treatments for adult brain cancer include watchful waiting, surgery, radiation therapy, chemotherapy, and targeted therapy.

    Newer treatments for adult brain cancer, such as biological therapy and proton beam radiation therapy are being studied in clinical trials.

    Assuming that incidence and survival rates follow recent trends, it is estimated that $4.9 billion will be spent on brain cancer care in the United States in 2014.

    Sentiment: Strong Buy

  • Reply to

    Dr. Scarlett said New Chapter...

    by scistats Nov 16, 2014 1:21 AM
    scistats scistats Nov 16, 2014 1:28 AM Flag

    Napo Pharmaceuticals, Inc. would also fit this new direction.
    Scarlett has something up his sleeve.

    Sentiment: Strong Buy

  • He's kind of one with nature on the reef and road...He's not actually going to buy New Chapter is he???

    Sentiment: Strong Buy

  • John A. Scarlett, M.D., Geron's President and Chief Executive Officer is playing his cards close, not revealing much if anything about Geron's future with Janssen other than moving Imetelstat to market for myelofibrosis.

    But, we already knew this. When pressed, Dr. Scarlett would only say that Imetelstat's dose would still need to be defined, but I suspect that one of the most respected doctors on the planet, Mayo Clinic's Dr. Ayalew Tefferi, might disagree. He has already perfected Imetelstat's dosing, side effects monitoring (LFT, etc.), genetic marker matching, and is now wrapping up duration and durability. We know that Dr. Tefferi is fast track phase 3 ready right now. Sure there is more to be done, but Dr. Tefferi has this under control, beyond this, he is the authority, not Geron and not Janssen.

    Piper Jaffary's Dr. Charles Duncan made a move to try to shake what might be the rest of the story from Dr. Scarlett. Imetelstat must make it to market for patients with MF, we know profit potential for this indication is responsible with orphan designation premiums and world-wide sales. But there is more.

    Take a look at what academia is #$%$ these days:

    Steven E. Artandi†, Stanford University, USA
    Telomerase in the 'Immortal' Germline

    Dirk Hockemeyer, University of California, USA
    Elucidating Telomerase Function in Human Tumor and Stem Cell Biology using Genetically Defined Cell Models

    Expect more cancer indications, likely in combination wtih what Janssen has on the table, specifically Imbruvica combinations. For example: AstraZeneca, Pharmacyclics and Janssen partner on immuno-oncology combination trials with IMBRUVICA® for haematological cancers.

    But, beyond haematological cancers, expect more. All of Geron's preliminary work points toward brain cancer, and I suspect this is what reallly got Janssen's attention.

  • Full steam ahead.
    No icebergs in sight.

    Sentiment: Strong Buy

  • scistats scistats Nov 14, 2014 11:46 PM Flag

    No you don't. Not right now.

    Let Janssen sit in the drivers seat for a while and smell the leather.
    Let them take the wheel and feel the acceleration.
    JAZZ on the surround sound.
    The supercharger kicks in at 7PPS with new indications.
    Listen to the high rev purr as dreams of Ibrutinib combos dance in their heads.
    Then watch the smile on their face when they open it up on the FDA fast track.
    Orphan turbos are an extra that cost more but, oh, are they worth it!
    Pop the hood so they can see the pediatric ependymoma tumor abolisher.
    Remind them of the five star driver and passenger side safety rating.
    Show them the "Car and Mayo" awards, tantamount to a cure.
    Then, when the time is right, discuss purchase and lease options again.

    Why pay low 20's when you can put this stallion in your stable out right.
    Or, Geron can be the next Angiotech getting royalties from Boston Scientific...just hope not to make the same mistakes that Wild Bill Hunter and Tom Bailey in spening a billion on AMI. What a saga that was! But it is vastly relevant on some scale to the story at hand.

    Scarlett's first rodeo this is not.

    Sentiment: Strong Buy

  • Nothing is off the table.

    Sentiment: Strong Buy

  • There is no "cap". 900 mil milestones are for costshare and not linked to the real payout which is royalty.

  • ASH
    Orphan/Fast track
    More indications
    International approvals

    Coming soon!

    Sentiment: Strong Buy

  • The United States likely will not be the first.

    Sentiment: Strong Buy

  • The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor.

    Fast track
    In 1997, the Food and Drug Administration Modernization Act directed the FDA to create a mechanism whereby important new drugs could get to patients more quickly than the standard and priority review programs already in place. Under this Act, drugs can be designated as "fast track" if they met two criteria:

    First, the drug must show promise in treating a serious life-threatening condition (such as AIDS, Alzheimer’s, heart failure, cancer, epilepsy, depression and diabetes), meaning that it will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.

    Second, the drug must have the potential to address an unmet medical need, meaning that no other drug or remedy either exists or works as well. If there are existing therapies, a fast track drug must show some advantage over available treatments, such as superior effectiveness or the ability to avoid serious side effects that occur with an already-available medication.

  • Looking forward to more indications.

    Sentiment: Strong Buy

  • MF is not the only game in town.

    Search PubMed:
    Telomerase inhibition abolishes the tumorigenicity of pediatric ependymoma tumor-initiating cells.

    Sentiment: Strong Buy

  • Naysayers crawling out of the woodworks.
    Get ready for FDA Fast Track, Breakthrough Therapy, Accelerated Approval.
    Get ready to run with the big dogs.

    Sentiment: Strong Buy

  • scistats scistats Nov 14, 2014 2:12 AM Flag

    Insurance companies.
    Imetelstat = CR and PR.
    It can cure in a treatment course.

    FYI: "BioMarin has slapped a price tag on its new drug Vimizim: $380,000 (PER YEAR, YES THAT IS PER YEAR, PER YEAR). That's hefty even for a rare disease treatment. But even at such nosebleed rates, Vimizim ranks in just third place on the list of the world's most expensive drugs."

    Per Form 8-K royalties range from mid teens up to low twenties on worldwide net sales.

    Please cross check my math.

  • I bet you are! I can hear collective head scratching. Yea, I am struggling too.

    Well, Janssen Biotech, Inc. knows what it is worth if Imetelstat is market approved.

    First, things first, Imetelstat will soon have orphan drug designation. No, this does not mean poor Oliver will be given Imetelstat by Fagin. It means the FDA will give orphan drug designation and approval after which time, Janssen can charge $1 million per patient treatment course.

    In the US, MF affects about 1.5 out of 100,000 people annually. MF is typically diagnosed in people between 50 to 80 years old, but can occur at any age.

    About 4740 patients annually in the United States alone. Since MD Anderson says " Each year, about 3,000 people in the United States are diagnosed with myelofibrosis", lets take an average. Make it 3870.

    Imetelstat can help about 25% of these folks. So, 967 folks per year. $967 million per year in United States alone. Lets say $2 billion world-wide for MF alone.

    Lets say Geron gets only .12 percent royalty. This is $240 million annually at peak estimated global sales.

    Trading at 20X earning would put us at 25 to 30 PPS for 25% of global myelofibrosis alone. Anything else is gravy on top of this.

    These are my quick back of the envelope number. Check my math please.

    Long live Ras Tefferi, Jah!

1.180.00(0.00%)Jul 15 3:59 PMEDT

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