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burnaka 716 posts  |  Last Activity: 4 hours ago Member since: May 19, 2010
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  • Interesting is that though Oppenheimer has one of the higher targets, their earnings projections lowered the projected EPS numbers as they were by far the lowest. This is curious because that is the exact metric zachs uses to determine their star rating system. POINT being zachs would not have chimed in recently if Oppenheimer didn't initiate coverage with a buy followed by their low eps estimates. So Oppenheimer lowered the bar to a bettter range, IMHO. Last year fully 1/2 the losses were paper losses, derivatives, hoping that pendulum swings both ways. The Average PT here is 12.83, OPP has 13.

  • burnaka@sbcglobal.net burnaka 14 hours ago Flag

    Full release: BOULDER, Colo., April 23, 2014 /PRNewswire/ -- Following the recent announcement by Novartis and GlaxoSmithKline that they have entered into a definitive agreement to exchange certain assets, Array BioPharma Inc. (NASDAQ: ARRY) reports that Novartis has indicated that it will continue to honor its obligations under the Array-Novartis agreement relating to binimetinib (MEK162), including obligations relating to support for ongoing clinical trials as specified in the agreement.

    In April 2010, Array entered into an agreement under which Novartis received exclusive worldwide rights to binimetinib. If Novartis' binimetinib development and commercialization rights are returned to Array, Novartis is required to provide support for ongoing clinical studies as specified in that agreement.

  • In April 2010, Array entered into an agreement under which Novartis received exclusive worldwide rights to binimetinib. If Novartis' binimetinib development and commercialization rights are returned to Array, Novartis is required to provide support for ongoing clinical studies as specified in that agreement.

  • Reply to

    Why invest in Opko, why now?

    by burnaka 18 hours ago
    burnaka@sbcglobal.net burnaka 15 hours ago Flag

    I believe both key and Ivax had multiple divisions too, where divisions could easily be spun out, but Frost elected not to do it. The structure here DOES make it EASY, which got me to think how Frost left himself a ton of options going forward. Then I thought, HE WILL NEVER RETIRE, but can generate a ton of investor wealth with spin offs. All really fantasy what ifs, he will do what ever in time, in Frost I trust,

  • Reply to

    Why invest in Opko, why now?

    by burnaka 18 hours ago
    burnaka@sbcglobal.net burnaka 16 hours ago Flag

    U R right, he has never done this before. My gut feeling is all. I think the sum of the parts, diagnostics, medical device, biotech could fetch more if pieced out. Lab corp buying diagnostics, PFE, Teva or whomever buying biotech, etc.. I expect the medical device section of opko to grow through mergers maybe trxc, which could be later sold to intuitive surg. Or as U say, if he sticks with the pattern he could sell all at once.

    I think he might not want to start a forth company but selling divisions he keeps busy building the remaining divisions, maybe to even compete with those he sold off.

    Spinning off divisions, then selling them is a sound strategy one my gut says is on the table as an option in time.

  • Reply to

    Why invest in Opko, why now?

    by burnaka 18 hours ago
    burnaka@sbcglobal.net burnaka 16 hours ago Flag

    Opko is still basically a start up, but it does generate 100 m in sales, not yet profitable. It is not a super buy out target yet. Frost will sell when OPKO is generating a few billion in sales. You might think, oh the pipeline this or that, but there are no cancer drugs, vaccines, etc that big pharma would consider must haves. The pipeline here is safe, with improvements on existing technologies, with very UNDER the radar potential. Give it 4-5 years for a buy out, well, my take anyway. I expect in time opko to spin off divisions as each generates about 1 billion or so in sales, just my theory.

  • Reply to

    Why invest in Opko, why now?

    by burnaka 18 hours ago
    burnaka@sbcglobal.net burnaka 17 hours ago Flag

    My PT is 30, but like your PT better. Now how does it get to 100. It can get to 30 if a few things break right, 5% global market share for Rayaldy, 300 million global 4k sales, plus the current near 100M sales gets us to 30 by eoy 2016. Now if Rayaldy does 40% market share you have your 100, we will see in about 30 months or so. 40% share is unlikely IMHO, 10-15% share is huge, opk to 40 if they get that penetration.

  • Reply to

    Why invest in Opko, why now?

    by burnaka 18 hours ago
    burnaka@sbcglobal.net burnaka 18 hours ago Flag

    4k WILL be bigger than many think. The Claros device bigger than many think, especially if short. Currently there is a PUSH in ENGLAND to have 4k become the standard diagnostic REPLACING biopsy. IF the NHS goes this route as many are advocating, other countries MIGHT follow.

    The chairman of Leighton Hospital Gary Steel who is at the forefront of prostate cancer testing in England stated " The former technique ( high PSA )meant biopsies were taken for people with elevated PSA readings, but the new technology means the charity will soon do away with biopsies altogether. These new machines ( 4k, Claros ) are able to tell straight away whether you have cancer or not. They are what we’re campaigning for the NHS to adopt,” said Gary.

    Gary Steele is a prostate cancer survivor and recognized as England's leading prostate cancer charity leader.

    There are other items in the pipeline, PSA test, testosterone test, Vitamin D test, and others will follow. The DEVICE is in over a dozen languages, and OPKO has developed a secure mobile app for the device, so far in English and German.

    The pharmacy division has research on items OPKO low key's like Finetec Israel and their dozen or so API products in development, and Spain which was just granted marketing approval for Citicoline. Not BLOCKBUSTERS but those could kick in 30-40 million in annual sales by eoy 2016.

    Opko has doubled revenue in each of the past two years and 2013 should show 120 million, Double 2012, and will keep doubling for a few more years.

    Opinion, yes, but I do know the pipeline well, but not as well as DR. Frost. Aristies and others figure they understand how to BUILD a COMPANY and GLOBAL sales force better than the TEAM at OPKO that has been doing it for
    OVER 20 years to the TUNE of Billions in sales, REALLY???

    The short contingent DISCOUNTS every thing Dr. Frost has in development at OPKO, they did the same to his pipeline at IVAX, how did that work out?

  • Reply to

    Why invest in Opko, why now?

    by burnaka 18 hours ago
    burnaka@sbcglobal.net burnaka 18 hours ago Flag

    The short contingent DISCOUNTS every thing Dr. Frost has in development at OPKO, they did the same to his pipeline at IVAX, how did that work out?

    Dr. Frost likes to jokingly say, " WE have always enjoyed a large short position, and though they have lost money, I have become friends with many."

  • First, Dr. Frost has BUILT two global companies deriving a substantial portion of income from these markets. Opko currently has footholds in Israel, Taiwan, Mexico, Chile, Peru, England, Spain, Uruguay, Russia and thCis countries.
    The competition RX to Rayaldy in the US alone is doing roughly 3 billion in sales. The global market is far larger than the US, with total US market estimated at 12 billion, Global is more than double that number.

    For argument sake let us call the global market 24 billion potential, at 5% market penetration we get 1.2 billion. I expect 1.5 in the US alone but that is for another rebuttal.

    4k WILL be bigger than many think. The Claros device bigger than many think, especially if short. Currently there is a PUSH in ENGLAND to have 4k become the standard diagnostic REPLACING biopsy. IF the NHS goes this route as many are advocating, other countries MIGHT follow.

    Part 2

  • burnaka@sbcglobal.net burnaka 19 hours ago Flag

    See Frost is using same approach here as Ivax and Key. It will take time but expect opko to lead in asthma. Notice too, OPKO has a thing for slow release products an area Frost pioneered. The slow release Rayaldy is just one example where release rate changes the efficacy of a drug, eliminates ALL side affects, and basically has the benefit of sitting in the sun 24/7.

  • But they still needed to solve the problem of Key’s main product. It treated asthma by combining a bronchodilator and a cough suppressant, which turned out to be “an illogical combination because with asthma you don’t want to suppress a cough — you want the patients to cough up the sputum,” says Frost.

    They feared that problem might cause the Food and Drug Administration to take the drug off the market in the United States. “At that time, a drug that was not approved in the United States couldn’t be sold abroad because they didn’t want companies dropping bad drugs on third-world markets,” Frost said.

    That would interfere with Key’s sales to Japan, “which was our life’s blood.” Frost said Jaharis — “who had a pretty good nose for opportunity” — learned that the bronchodilator component, theophylline, was the important ingredient for asthma suffers. A small trial in Florida showed theophylline did very well, but only within a narrow “therapeutic window” — too much was toxic, too little had no benefit.

    Key decided that the drug worked best as a time-release capsule, which they marketed under the name Theo-Dur. Sales soared and made Key a hugely successful company. “At a certain point, it became the leading drug for asthma in the country,” Frost says.

    It’s this tale of Theo-Dur — a drug inherited during the takeover of a nearly bankrupt company — that prompts Zaias, the fellow dermatologist, to say that Frost is “unbelievably clever and very lucky.”

  • burnaka@sbcglobal.net burnaka Apr 22, 2014 5:53 PM Flag

    Zacks bases their buy sell hold calls on earnings upgrades and downgrades regardless of the companies longer term prospects. The most important sentence in their call is the last one where they state long term horizon. The recent opko stock performance mirrored the sector, but it will out perform again once phase 3 results hit. Opko is a 2016 story, should get to no less than 30. At that point they should have two wholly owned drugs on the market, royalties from rolapitant, 5-6 diagnostic tests, Claros device, and maybe the inhaler.

    Keep in mind too, our partners, if one of those companies gets an approval Opko COULD partner for distribution. So a few yet unknown opportunities exist here. Not all the research being done by Opko is obvious even when studying their website. For example Opko Chile lists an item or two that Opko does not list anywhere else. Opko Spain has an extensive veterinary portfolio and does not list their veterinary research. There is Israel, and the API division with about a dozen new compounds that will go to market. It will take a little time but in Frost I trust.

  • Reply to

    NVS acquired GSK oncology drugs

    by dcaf7 Apr 22, 2014 11:01 AM
    burnaka@sbcglobal.net burnaka Apr 22, 2014 5:18 PM Flag

    Should not have an affect, mek 162 benefits nras and braf mutations, Trametinib treats braf mutation.

  • Reply to

    OPK News

    by icemandios Apr 22, 2014 3:08 PM
    burnaka@sbcglobal.net burnaka Apr 22, 2014 4:06 PM Flag

    It is part of the prolar deal, but it is preclinical, ie has not started phase 1 at least according to the Jan 14th JPM conference.

  • Reply to

    MEK inhibitors from ARRY at ASCO 2014

    by dcaf7 Apr 22, 2014 8:31 AM
    burnaka@sbcglobal.net burnaka Apr 22, 2014 1:53 PM Flag

    The Novartis website shows 2015 for first fda app for an arry partnered drug, 2016 for the second. Astra zenica ? not sure but looks like 2017, so one drug a year for next three years, this does not include wholly owned which looks like 2016/2017. At least one could/should compete for standard of care.

  • Reply to

    MEK inhibitors from ARRY at ASCO 2014

    by dcaf7 Apr 22, 2014 8:31 AM
    burnaka@sbcglobal.net burnaka Apr 22, 2014 12:27 PM Flag

    Thanks for the update, the Nemo, abstract TPS9102 is a Novartis partnered drug, from the Array website:

    The second Phase 3 study is in NRAS-mutant melanoma, which Novartis is conducting, and began in July 2013. The NRAS-mutant melanoma study, called NEMO (NRAS Melanoma and MEK Inhibitor), will evaluate the efficacy and safety of MEK162 compared to dacarbazine in 393 patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS-mutant melanoma. The primary endpoint is progression-free survival, and the key secondary endpoint is overall survival. The estimated primary completion date for the NEMO study is October 2014.

    Estimated completion dates can be off by a couple months, and the data evaluation can take a few more, but Novartis/Array should be going to FDA by no later than April 2015, approval by OCT 2015. Not positive but I believe this will be the first drug to fda and farthest along. The last in your list MILO should finish shortly after the Nemo study and go the FDA mid 2015 for late 2015 or early 2016 approval.

  • burnaka@sbcglobal.net burnaka Apr 22, 2014 11:20 AM Flag

    22 more days for the abstract release.

  • Reply to

    Dry powder inhalers-Inspiromatic

    by adsmith2036 Apr 19, 2014 8:55 PM
    burnaka@sbcglobal.net burnaka Apr 21, 2014 11:15 AM Flag

    We plan to use the Inspiromatic™ device to test the inhaled form of OPKO's new sulfated disaccharide drug against these disorders. This drug product is still undergoing pre-clinical testing prior to submission of an IND, but animal data indicates safety and efficacy for both inhaled and orally delivered forms. Of course, we believe that Inspiromatic™ can improve outcomes of treatment with other drugs, those presently available in more 'standard' type inhalers, as well as new inhalation drugs being developed. This acquisition fits our strategy of developing new products that address large markets in need of more effective therapeutic solutions."

    Opko drug still preclinical, so a few years away. Device needs go straight to phase 3 and still get approved. Licensing Arry drug for asthma ready for phase 3 works for me, lol. The device could go to FDA by mid 2015 and be on the market by early 2016.

  • burnaka@sbcglobal.net burnaka Apr 17, 2014 7:09 PM Flag

    Jane also picked up another 10K shares bringing her total to roughly 26.5 Million. Three insiders buying this month,, Jane, Rubin and the other guy, um what's his name.

KO
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