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jjjorgen

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  • Athersys Should Gain At Least 50% [View article]
    Strategic partnership on Weight-Loss to be entered into 1st Quarter of 2013! You heard it here first!
    Athersys:
    In addition to our regenerative medicine programs, we have earlier stage pharmaceutical development programs are also focused on addressing significant unmet medical needs, such as obesity, related metabolic conditions, such as type 2 diabetes, and certain neurological indications. Over the past few years, obesity rates in the United States and many other countries have increased dramatically, especially among children. Obesity contributes directly to elevated rates of heart disease, diabetes, cancer and a range of other conditions, and is estimated to affect more than 100 million Americans.

    Despite the growing magnitude of the obesity problem, there are no safe and effective weight loss drugs approved for use. We believe that we have established a best-in-class program that could enable us to develop safe and highly effective new therapies to treat obesity and potentially other conditions.
    Dec 27, 2012. 07:43 PM | Likes Like |Link to Comment
  • A Comprehensive Analysis Of NPS Pharmaceuticals [View article]
    Well put, Sir!! God bless your child, as I can not personally understand yours, and your childs pain, I can only pray for your family!
    Dec 27, 2012. 04:43 PM | 1 Like Like |Link to Comment
  • A Comprehensive Analysis Of NPS Pharmaceuticals [View article]
    NPS Pharmaceuticals, Inc. (NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that it has established a patient-centric distribution and clinical service network for Gattex® (Teduglutide [rDNA origin]) for Injection, for subcutaneous use. The network is comprised of leading specialty home infusion providers, including Accredo Health Group, Inc.; BioScrip; Inc.; Coram, LLC; ThriveRx; and Walgreens Infusion Services. In addition to dispensing Gattex, the company’s contracted providers will provide clinical services to support the use of Gattex in reducing dependence on parenteral nutrition (PN) and intravenous fluids (IV) for patients with short bowel syndrome (SBS). Gattex was approved by the U.S. Food and Drug Administration (FDA) on December 21, 2012 as a treatment for adults with SBS who are dependent on parenteral support. Gattex is the first-and-only FDA-approved therapy for the long-term treatment of SBS and the first major treatment advance for SBS in nearly 40 years.
    Dec 27, 2012. 08:41 AM | Likes Like |Link to Comment
  • A Comprehensive Analysis Of NPS Pharmaceuticals [View article]
    Really Biomaster? Can you place yourself in these people's shoes? How many drugs are out there with numerous labels on them? Do you watch TV? I get sick of hearing all the deathly warnings spewed out on the many drugs advertised. Do you understand this statement?:
    There is no complete therapeutic cure for this disorder, and this disease is listed in the database of rare diseases that is maintained by the National Organization for Rare Disorders (or NORD) as well as Orphanet (orphan number ORPHA104008) which is a portal for rare diseases and orphan drugs.
    Where there is no medicinal cure now, do you believe these few thousand patients won't take a little risk for some physical benefit?
    Get Real!
    Dec 26, 2012. 05:36 PM | 1 Like Like |Link to Comment
  • A Comprehensive Analysis Of NPS Pharmaceuticals [View article]
    Thank You, well written article!
    Dec 26, 2012. 04:32 PM | 1 Like Like |Link to Comment
  • 4 Highly Shorted Stocks Under $5 Being Bought By Insiders [View article]
    Once 4Score is on the market in the U.S., value will begin to be seen, shorts will begin to cover.

    December 18, 2012
    OPKO Health Completes Acquisition of CLIA Laboratory
    MIAMI--(BUSINESS WIRE)-- OPKO Health, Inc. (NYSE: OPK) announced that is has completed the acquisition of Prost-Data, Inc., doing business as OURLab, a Nashville-based CLIA laboratory with 18 phlebotomy sites throughout the U.S. and an experienced national sales force calling primarily on urologists.

    In addition to operating as a stand-alone laboratory testing service, OURLab will provide OPKO a commercial platform to support the near-term U.S. commercial launch of its novel panel of kallikrein biomarkers and associated algorithm (4Kscore™) for the detection of prostate cancer.

    Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer, commented, "We look forward to working together with OURLab's talented personnel to support the U.S. launch of the important 4Kscore™ prostate test."

    Merry Christmas!
    Dec 25, 2012. 10:47 AM | Likes Like |Link to Comment
  • Stimuvax Trial Failure: A Value Opportunity In Oncothyreon [View article]
    Oncothyreon is toast, Sorry! Better Bio Bets out there!
    Dec 24, 2012. 01:47 PM | Likes Like |Link to Comment
  • NPS Pharma Drifts Higher On Potential Orphan Drug Approval [View article]
    $9/share after approval. I am expecting a few upgrades, and a drift back to $11/share by January. Longs should accumulate at $9/share, and hold till at least $11/share.
    Dec 22, 2012. 09:04 AM | Likes Like |Link to Comment
  • Hemispherx's Ampligen Is Unlikely To Receive FDA Approval [View article]
    I feel so bad for those with the disease, and lost money on the trade, but Feurstein makes a good point:
    http://bit.ly/SOuq7R
    Dec 18, 2012. 06:08 PM | Likes Like |Link to Comment
  • Tuesday's Small-Cap Biopharma Catalyst Trade List [View article]
    OK, I got out of this one today at $.44/shr. I did lose, and will look to recoup on another trade. What I read today finished it. Last note, we both can be thankful for not having the disease. God Bless those!
    Dec 18, 2012. 06:05 PM | Likes Like |Link to Comment
  • Hemispherx's Ampligen Is Unlikely To Receive FDA Approval [View article]
    I think Ampligen has a chance, much explained in the comments above. I feel this past trial will play a large role in the decision. CFS really have very little else to choose from:

    A Sick Group – with Karnovsky scores from 40-60 this group was pretty ill. The median Karnovsky score for the group was 50 which translates out to ” requires considerable assistance for daily care”. (Hemispherx called the study members ‘severely debilitated’). Most were middle-aged women (67-77%) (average age 43 years) who had been ill for about 9 years. Given the quality of the doctors participating in the study there was no question about whether they had CFS or not.

    This was a big study over 200 people starting the study and with 194 patients completing it.

    The Test – the participants were asked to walk until they could walk no more on a treadmill which tilted up and got harder to walk on the longer they walked.

    The Results

    Exercise Tolerance – At the end of 40 weeks, the patients on Ampligen were able to stay on the treadmill about 108 seconds longer while the patients not on Ampligen were able to stay on the treadmill about 27 seconds longer. This translated to an 16.6% increase in exercise tolerance – far surpassing their goal of at least 6.5%. In fact, according to the study, the 16.6% increase makes Ampligen the best exercise intolerance reducer yet tested by the FDA. (The next best result was posted by Tracleer for pulmonary hypertension (10.6%) and then Remodulin (8.0%).)
    Safety Issues -Few serious side effects were seen in this study and with earlier data suggesting that Ampligen may, in fact, have positive effects on the heart, hopefully the FDA’s fears have been allayed.
    Decrease In Other Drug Use – Hemispherx was eager to show that taking Ampligen enabled patients to reduce their use of other drugs. Interestingly, most patients in both the saline and Ampligen arms of the study reduced their medication usage but patients on Ampligen reduced their drug use more than those on the placebo. (Some of the drugs that were reduced when Ampligen was being used may have contributed to the heart issues the FDA was concerned about.)
    Well-being Scores – Ampligen treated patients increased their Karnovsky scores from a median of 50-55 (requires considerable assistance for daily living to requires less assistance for daily living), their vitality score doubled and their activity score went up somewhat (but was ‘significant’). Interestingly their SF-36 scores, a common measure in CFS studies to measure perceptions of general health, did not budge at all.
    Check Them Off – Ampligen increased exercise tolerance, reduced medication usage, improved most well-being scores and was safe.

    Conclusion -Hemispherx has taken two extensions, the latest coming earlier this year, from the FDA for its response to the FDA concerns. This study looked to be that response but it appears that this study simply analyzes data taken from a 2004 study….Hemispherx appears to hope that this analysis of the old study results will help them with the FDA.

    Will it be enough? Disorders for which no drugs are available can get a break with the FDA but Hemispherx has not yet responded to several of the FDA’s concerns; it did not do a 300 person study, did not assess responses to different doses and did not do a rodent study.

    Is Ampligen the cure for ME/CFS? Not according to this study but it does appear to have passed several FDA criteria for approval. While the results weren’t stunning we know that some people do very well on Ampligen and if the FDA approves this drug determining who it works for will be important and could ultimately help to subset this disorder. Hemispherx believes the work its doing with a biotech firm called Chronix (see below) will allow it to pinpoint individuals who will benefit from the drug.
    Dec 18, 2012. 10:12 AM | Likes Like |Link to Comment
  • 10 Recent CEO Insider Purchases To Consider [View article]
    OPK ~ January, we bust up over $5. Good things coming
    Dec 17, 2012. 06:55 PM | 1 Like Like |Link to Comment
  • Tuesday's Small-Cap Biopharma Catalyst Trade List [View article]
    $650?? to gamble on a double! No-brainer, I'm in for 10,000 shares, no risk, no reward. Most bio's are a gamble no matter how you look at them.
    Dec 17, 2012. 06:12 PM | Likes Like |Link to Comment
  • 3 Small Pharma Companies With Major Catalysts In 2013 [View article]
    Long on ACRX!! Three Arch Partners discloses a 17.5% stake.
    Thanks for the quality write-up!
    Dec 17, 2012. 06:07 PM | 1 Like Like |Link to Comment
  • 3 Pharmaceuticals With Promising Growth Catalysts To Consider Now [View article]
    When will the 4kScore actually get launched in the U.S.?? Is Europe mentioning usage at this point? Thanks for your article! Opko should have a great 2013.
    Dec 15, 2012. 01:59 PM | Likes Like |Link to Comment
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