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Medivation, Inc. (MDVN) Message Board

dbeee2 6 posts  |  Last Activity: Jul 7, 2014 2:32 AM Member since: Feb 13, 2013
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  • dbeee2 dbeee2 Jul 7, 2014 2:32 AM Flag

    Oh my, you are at best misinformed and at worst disingenuous. Options to buy are more skin in the game than buying shares direct. If you buy shares direct you can sell at any time. If you accept options to buy in lieu of reasonable compensation you have just bet the farm on success. Extrapolating their position to one of not believing in the success of the company is laughable. I'm long and holding. This is a very useful product with no competition. Approval is just a matter of time. Maybe it will be approved this time and maybe not, but it will eventually. All of the insiders options are sitting at $2.27 .

    Sentiment: Hold

  • Reply to

    SQUALAMINE significantly improved visual acuity

    by redyns3 Jun 25, 2014 9:53 AM
    dbeee2 dbeee2 Jun 27, 2014 12:18 AM Flag

    As an investor I am very comfortable with those statistics. If I was sitting on an FDA committee I would not recommend approval on such scant data. I am here to make money though and my comfort level just went up a notch when I read the data.

    On your second point "So, it seems odd that the anatomical response does not match/correlate to the VA difference." How have you come to that conclusion? I have not seen any data talking about the anatomical response. I have only read the presentation the company gave on the 24th. Point me to that source please. An anatomical response would be reassuring. However, the FDA is moving away from progression free survival and are looking at overall survival and quality of life in cancer drugs. Visual acuity is a more important endpoint to the patient in this disease. They don't come in complaining about their lesions LOL.

    Yes Phase III weeds out some lucky Phase II results. This data is weak for the primary endpoints but fairly strong for the secondary endpoints. At least they are not data mining for subgroups. The success of a trial is to some extent a function of how well it was designed and not the efficacy of the product. Fovista does not seem too proud to use visual acuity as a primary endpoint. Phase III will learn from Phase II shortcomings.

    Lucentis is $2000 dollars a shot for 6.2 letter improvement or about $322 per letter per month. How much is another 4 letters worth to you? If you had ARMD and I offered it to you for free, would you take it today? Or would you say this is a dangerous sham product and wait for Phase III?

    If the data at the end of the trial strengthens a bit, I think this could get orphan drug status while Phase III is being conducted. I haven't seen a downside to this product yet.

  • Reply to

    SQUALAMINE significantly improved visual acuity

    by redyns3 Jun 25, 2014 9:53 AM
    dbeee2 dbeee2 Jun 26, 2014 2:22 AM Flag

    redyns3, do you know what retreatment criteria was used for the study? For ARMD retreatment with Lucentis is based on loss of visual acuity based on DME which is a bit subjective but the best that can be done. In addition Lucentis is typically administered monthly until visual acuity stability is attained. Looking at the 9 month visual acuity data the squalamine group continued to improve during the 9 months and hence no reason to back off on Lucentis. The control group seemed to have peaked with visual acuity improvement around week 24. You would not expect much divergence on the number on lucentis injections in such a short period with this kind of data. In fact you could argue that the sqaulamine arm had not stabilized and the control arm was losing acuity at the end and so you ended up with the same number of injections. This is just speculation on my part though because I have not seen the retreatment criteria used for this study. I think the results are terrific.

  • Reply to

    Misinformation, but NOT from OHRP researchers

    by l_dopa Jun 25, 2014 5:33 PM
    dbeee2 dbeee2 Jun 25, 2014 7:38 PM Flag

    Let's be fair here. If the primary endpoint was a reduction in the number of lucentis injections, the difference in the two groups was small and arguably clinically insignificant even if it was statistically significant. In this situation PRN was not determined by the patient but by the doctors. I presume they made that decision on criteria such as OCT, fluourescein angiography, visual observation in addition to visual acuity. Visual acuity was a secondary endpoint. Sometimes the success of a study is getting lucky on choosing your endpoints and sample sizes. This data is also interim data. Achieving statistical significance before the study is complete is not common. Phase 2b data will dictate the sample size and study design going forward. This will go forward. Fovista researchers have no qualms about making visual acuity improvement a primary endpoint and neither will squalamine researchers.

  • Reply to

    Comparison to Fovista/Lucentis co-treatment

    by billwilliams836 Jun 25, 2014 12:47 PM
    dbeee2 dbeee2 Jun 25, 2014 6:52 PM Flag

    Time to market is an unfortunate situation but it will still have a market when it gets there. As a side note, I would take a $50 avastin injection any day of the week over lucentis at $2000 even with my insurance. The insurance coverage is so lousy I would be way ahead financially. With an annual deductible of $2500 dollars I can pay for my own avastin injections without insurance.

  • Reply to

    Comparison to Fovista/Lucentis co-treatment

    by billwilliams836 Jun 25, 2014 12:47 PM
    dbeee2 dbeee2 Jun 25, 2014 2:09 PM Flag

    Certainly looking at Fovista is important. But there are many things to think about. Fovista is in combination with Lucentis and it appears it is being developed to be injected with Lucentis. So the market place is all patients who have access to a retinal specialist. Assuming it is a combination injection, it can't be used off label separately. Look at how much avastin is being used off label. If squalamine eyes drops show any efficacy at all, it will be prescribed off label to every patient who is on avastin, lucentis, eyelea and even patients who reject injections. I think the data at this point is comparable to Fovista and there is room for more than one player in this space. I think the potential is good and this will make it to the market place at some point. And a 3% reduction in the Medicare bill for lucentis injections (6.4 versus 6.2) is not insignificant either. It would be nice if it were larger. Now whether OHRP is worth the current market cap, I don't know. But I sold high and bought back in at the low point yesterday.

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