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Energy Transfer Partners, L.P. Message Board

burnaka 442 posts  |  Last Activity: 17 hours ago Member since: May 19, 2010
  • burnaka@sbcglobal.net burnaka 17 hours ago Flag

    Oh by the way, put Silver.platnum on ignore. He adds nothing to the understanding of the pipeline.

  • burnaka@sbcglobal.net burnaka 17 hours ago Flag

    The KEY, THE BIG deal about Rayaldee is in the SUMMARY. It simultaneously CORRECTS shpt and Vit D insufficiency at the same time. The OTC does not, the generic hormone does not!!!!!! This was the point LW missed, that Rayaldee corrects both conditions. From the CC.

    So in summary, our early qualitative research with nephrologists and endos has shown that there's a clear unmet need for a product that could simultaneously correct both vitamin D insufficiency and SHPT, and with a high degree of interest in trying Rayaldee once it's approved.

  • burnaka@sbcglobal.net burnaka 18 hours ago Flag

    Discussing the pipeline, yes, that is always a good idea.

  • burnaka@sbcglobal.net burnaka 18 hours ago Flag

    Do what you think best but study opko and the timeline as it relates to product launch. This should get to 28-32 by eoy 2016. Should have no less than 800M revenue by then ( MINIMUM ) up from current 100m. Good Luck.

  • burnaka@sbcglobal.net burnaka 19 hours ago Flag

    Also the HORMONAL GENERICS have big drawbacks:

    So basically in a lot of cases, we are hearing that they are choosing to treat either SHPT or vitamin D insufficiency but not both. And while it would seem the rationale on the surface to stop treating vitamin D insufficiency in favor of treating only SHPT, it actually makes sense from the standpoint that hormonal products tend to exacerbate mineral metabolism disorders and this leads to clinicians having to try to titrate phosphate binders, nutritional and hormonal forms of vitamin D, in order to maintain control of the calcium, phosphorus and PTH, and it simply becomes too complicated for many clinicians to actually want to deal with.

    So now in addition to asking about their current treatment practices, we want to share with them a product profile that represented what we believe could be the Rayaldee clinical study results. And in response, based on the Rayaldee product attributes that we presented to them and the way that they are currently practising, they expressed a high degree of interest in trying Rayaldee.

  • Charles Bishop, the CEO of the renal division ( Rayaldee ) stated on the earnings call that Opko could reach the MAJORITY of Drs. with a small sales force. So they will not likely partner. n his words:

    Primarily nephrologists and endocrinologists care for these patients and they can be effectively reached with a small specialized sales force.

    Given that there are at least 4 million patients with SHPT derived from vitamin D therapy or about 4 million to 4.5 million patients, if we were to price Rayaldee at the lower cost range of vitamin D therapy, which is $3,000 per year, the U.S. CKD market alone represents a potential $12 billion revenue opportunity.

    So in summary, our early qualitative research with nephrologists and endos has shown that there's a clear unmet need for a product that could simultaneously correct both vitamin D insufficiency and SHPT, and with a high degree of interest in trying Rayaldee once it's approved.

    Now in addition to the research with clinicians that I've just outlined, I can tell you that we also recently initiated research with both payors and patients and we expect to have something to share with you with regards to those findings on a future call.

    Bottom line is OTC D works for some patients, but less than half, the generics highly touted by LW actually increase Vitamin D insufficiency but do lower shpt some times too much.

    Rayaldee is a single drug and corrects both.

  • burnaka@sbcglobal.net burnaka 20 hours ago Flag

    Charles Bishop, the CEO of the renal division ( Rayaldee ) stated on the earnings call that Opko could reach the MAJORITY of Drs. with a small sales force. So they will not likely partner. n his words:

    Primarily nephrologists and endocrinologists care for these patients and they can be effectively reached with a small specialized sales force.

    Given that there are at least 4 million patients with SHPT derived from vitamin D therapy or about 4 million to 4.5 million patients, if we were to price Rayaldee at the lower cost range of vitamin D therapy, which is $3,000 per year, the U.S. CKD market alone represents a potential $12 billion revenue opportunity.

    So in summary, our early qualitative research with nephrologists and endos has shown that there's a clear unmet need for a product that could simultaneously correct both vitamin D insufficiency and SHPT, and with a high degree of interest in trying Rayaldee once it's approved.

    Now in addition to the research with clinicians that I've just outlined, I can tell you that we also recently initiated research with both payors and patients and we expect to have something to share with you with regards to those findings on a future call.

    Bottom line is OTC D works for some patients, but less than half, the generics highly touted by LW actually increase Vitamin D insufficiency but do lower shpt some times too much.

    Rayaldee is a single drug and corrects both.

  • 4k Spain launch shortly after. TSRO will be good heading into that news, opko could spike with it, or on final Phase 3 Data. Two new marketable Drugs next year, potential market US only 12.5B, at 10% share revenue hits 1.25B, before any blood tests, potential market 5B, at 5% 250m, potential 1.5B revenue FROM US sales, Double that outside US. Getting there is half the FUN.

    Getting closer, day by day,

  • Reply to

    Soros sold nearly all of his OPK

    by farryman008 Aug 18, 2014 4:17 PM
    burnaka@sbcglobal.net burnaka Aug 18, 2014 4:48 PM Flag

    There was a ton of churn after the Yellin call last Q, I was more surprised to see that the net number of shares bought was up 9 or so million than Soros selling many positions and lightening up on his few biotechs. For ALL we know he bought them back. 49 funds decreased, but 95 increased their positions. Those that increased likely bought other bio positions after the Yellin call, and the pull back.

  • burnaka@sbcglobal.net burnaka Aug 18, 2014 2:49 PM Flag

    There are certainly enough buyers waiting to buy if it starts to run, 48 million shares worth or there about.

  • burnaka@sbcglobal.net burnaka Aug 18, 2014 2:42 PM Flag

    I think opko gains strength next month based on the two drugs, TSRO is a trade for sure. TSRO could pop 2-3, opko, no guess, but I do think it gains ground. Figure Rayaldee, Rolapitant, Plus 4k Europe all next month could get Opko moving word on insurance for 4k pending, and they are NOW already working on insurance for Rayaldee. Rayaldee will BANG out of the gate.

  • Testosterone and PSA test by mid 2015, Vitamin D test Q3, Rayaldee approval, Rolapitant approval Q3.

    4 Blood tests, two new drugs, Claros device is at FDA now, soon to market, Inspiromatic deal could be in the works. All under one year.

    Short term catalysts, Phase 3, one month, NDA one month, NDA 4 months. 4k Europe launch 2 months, South America 4 months ( insurance ID number for 4k, Jan-Feb )

    If you plan on adding no time like the present before the new drug applications.

  • burnaka@sbcglobal.net burnaka Aug 15, 2014 1:27 PM Flag

    This is why winging it is wrong, and relying on memory without double checking is a mistake:

    • PSA: 30 million tests, $750 M
    • Testosterone: 15 million tests, $525 M
    • Vitamin D: 70 million tests, $3.5 B

    Apparently D will be the biggest claros test, not testosterone. I think/guess that with patients with ckd the Drs. likely test for D levels regularly. Roughly 170 urologists are using 4k, which is about 1% of all urologists. With the addition of these other 3 tests they will want the Claros device or have a competitive disadvantage. Using 4k could lower their medical insurance since less patients will suffer biopsy side effects like urinary issues, infection or erectile issues.

  • burnaka@sbcglobal.net burnaka Aug 14, 2014 6:53 PM Flag

    Pre-submissions asks the fda WHAT do we need to do to get approval, what tests, etc., should we do. Then you do whatever is deemed necessary, ie., run the tests. You then submit results hoping you followed the guidelines. At that point the 90 day window opens. So total time is FAR greater than 90 days, the tests need be done, but that said, Opko believes all three tests get approval in under one year, ALL good.

  • burnaka@sbcglobal.net burnaka Aug 14, 2014 6:32 PM Flag

    Thanks for looking that up. I was going to but got side tracked. I think the PSA and testosterone tests BLOW away 4k by many many millions. These make the CLAROS device a must have by urologists. Testosterone has by far the biggest market I think, followed by D. I am winging that info, but think I am right.

  • burnaka@sbcglobal.net burnaka Aug 14, 2014 2:23 PM Flag

    The tests are lined up this way,4k first, psa second, testosterone third, vitamin d, just prior to Rayaldee approval, So all on the market by next Oct.

  • Reply to

    Pump and Dump Season

    by merrimack71 Aug 13, 2014 12:49 PM
    burnaka@sbcglobal.net burnaka Aug 14, 2014 12:31 PM Flag

    CL be nice to Merrimack, I was disappointed she went on that cruise and did not take me along but I am a forgiving sort. Though she likes to toot her own horn, her calls on arry have been on target. Her buy's have been good entry points, though she might have missed a few, or not posted them. Not sure on exit points, but she made money.

  • burnaka@sbcglobal.net burnaka Aug 14, 2014 12:21 PM Flag

    From the earnings CC:

    I'll conclude now with the Claros 1 which is our physician in-office analyzer for doing rapid finger-stick blood sample testing. The machine is actually well done, we've been using the instrument as it is for now several years. We've been actually developing the test for both Total PSA and testosterone to really build out our urology franchise and provide them with two of the highest volume test to be conducted in the urology office setting. We submitted our pre-submissions to the FDA for both of those assays and we're expecting to begin our clinical trials in the third quarter or early fourth quarter and to complete those rather quickly since these are both 510(k) submissions.

    So starting trials by Q4, will finish by Q2 at the LATEST is my guess.

  • Reply to

    Every kittle deckine

    by walstretguru Aug 14, 2014 10:08 AM
    burnaka@sbcglobal.net burnaka Aug 14, 2014 11:45 AM Flag

    IAB is showing the fluctuations depending on when you look. Before market yesterday only 100K at IAB, within minutes it spiked to 900K, then down to 750, closed out around 700. I did not look until now, it is back down to 450K, GUESS it depends on how often you look. In the past 6 weeks it was as low as zero briefly, and as high as 1.2m available, but much of what is happening is the shorts entering and exiting. The last published short number shows an uptick after two down periods, the net since mid June is down 3.2M, and they managed to not spike OPKO, a feat in itself. June 13 price close 9.03, they are manipulating beautifully.

  • burnaka@sbcglobal.net burnaka Aug 14, 2014 11:07 AM Flag

    In the next 6 weeks 4k score will be brought to market by Opko Spain, followed in early 2015 by Opko Mexico, and Opko Chile. Hopefully we have our insurance ID by early 2015, hopefully our British partner gets insurance approval shortly. In this same 6 week time frame Rolapitant FILES the NDA and then we get second phase 3 read on Rayaldee, first read was .0002 so not an issue. NDA on Rayaldee in next 14 weeks.

    That is not light at the end of the tunnel, but it is coming at you quicker than you think.

ETP
57.12Aug 19 4:06 PMEDT

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