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  • One Drug To Rule Them All: Medivation's Xtandi To Dominate Prostate Cancer Market [View article]
    Hey Stock Doc,
    Thanks for the comments, please see my reply above. Hopefully it clarifies the points about seizures.
    Aug 20, 2014. 02:47 PM | Likes Like |Link to Comment
  • One Drug To Rule Them All: Medivation's Xtandi To Dominate Prostate Cancer Market [View article]
    Thanks for bringing these points up, let me address them:
    1). This is a matter of opinion I suppose. I am mainly referring the slowing growth of Zytiga sales over the past year vs the previous year. To clarify, 2012 sales were 961M, 2013 were 1.7B, and this year we will probably see around ~2.1B. I would call that slowing down. This article also makes the same point for recent quarter growth (though is not including the most recent quarter): http://bit.ly/1naNUx2 .

    2). Apologies for not being clear here, what we meant was one pill TYPE a day (i.e. drug vs. drug + prednisone in Zytiga's case). You are correct that for Xtandi itself the rec. dose is 160mg @ 40mg (so x4). The article has been edited to make this clear.

    3). This was in fact a typo, it was meant to read "associated with use of XTANDI...". The following sentences should make more sense now with that edit. You are correct, Zytiga has no seizure issues. Our point was the previous concerns over Xtandi's seizures were stemmed from AFFIRM, however in PREVAIL these concerns were largely tempered since there was no difference in seizures vs. placebo in PREVAIL: http://bit.ly/1naNXci

    4). Someone mentioned that prednisone does not have diet restrictions. It does, and it is a known issue with Zytiga: http://bit.ly/1naNXcm

    5). Zytiga 2:1 advantage over Xtandi in OS? What? Can you please explain what you are referring too
    Aug 20, 2014. 02:45 PM | Likes Like |Link to Comment
  • One Drug To Rule Them All: Medivation's Xtandi To Dominate Prostate Cancer Market [View article]
    Hey biobetter,

    Agreed, we didn't cover ODM201 or ARN509 ("son of Xtandi") in this article, which is currently PhIII. That is the ultimate question but we won't know for sure until JNJ starts rolling out more data and comparisons can be made. My opinion there is that you may be getting diminishing returns on the "potency" of the AR inhibitor. Many of the mechanisms of resistance to Enzalutimide appear to be "bypass" signaling (I.e. GR up regulation), which basically tell you that Enza is doing as good of a job inhibiting AR as can be (in most cases - there are non Enza targetable AR mutations/splice variants as well).

    In the meantime, I think we have some good upside left in MDVN before JNJ steps into the scene. Would love to hear a counter!
    Aug 5, 2014. 11:36 AM | Likes Like |Link to Comment
  • Innate Pharma And The Role Of The Innate Immune System In Cancer Immunotherapy [View article]
    Thanks for the comments.

    StevenLissner, Inovio Pharma (INO) is interesting, but is using cancer vaccines (DNA based), which has largely failed as effective cancer treatment.

    ArthurSoto, OncoSec Technologies (OTCQB:ONCS) is using eletroporation to deliver IL-12 to generally stimulate the immune system at the tumor site. This is much different than the antibodies Innate Pharma is using to inhibit the inhibitory receptors on immune cells to increase their anti-cancer effects.

    Traderspx, investing in companies focused on cancer therapeutics is a risky proposition; this sector of the pharma industry has the highest attrition rates for drug discovery, so your hesitance is not unwarranted. However, examples of failures in this sector does not condemn every cancer therapy in development to eventual failure. For every example of you provide such as AVIBiopharma, one can name a counterexample of a success story such as Plexxikon. Even for your examples of Avastin, Cetuximab, and Tarceva, you grossly misrepresent the efficacy of these drugs. While none of these drugs have a 100% response rate in patients, there are still many examples of patients whose lives were extended for significant amounts of time with these drugs. And with advances in biomarker discovery and improved patient stratification, we are beginning to understand the factors that dictate who will and won't respond to a specific therapy, allowing companies to design trials and prescribe drugs in a more precise manner. It is in this new era of drug development and precision medicine in which cancer therapeutics are becoming more attractive investment options.
    But as you will agree, not all cancer drugs will succeed, and the difficulty lies in choosing the most likely winners in this process. That is where we believe our analysis provides the most impact and benefit. True, successful Phase I and II trials does not guarantee success in Phase III and market approval. Luckily, for reasons we've outlined above, our bullishness toward Innate Pharma's extends far beyond their current clinical trial results. Innate Pharma's cancer immunotherapy approach is founded on a sound scientific data and rational, which could contribute to it's future success.
    May 5, 2014. 12:01 AM | 1 Like Like |Link to Comment
  • Exelixis: Promise In The Pipeline [View article]
    Thanks for your comment. We took the $352 million number from their 10-Q filed on August 6 2013. From the balance sheet on that form, we took cash and cash equivalents ($131.8 million) + short-term investments ($220.2 million) = $352 million.
    Oct 7, 2013. 02:33 AM | Likes Like |Link to Comment
  • DiaDexus: A Hearty Choice [View article]
    Thank you for providing information on the Galectin-3 diagnostic test being commercialized by BG Medicine (BGMD). Since it applies to patients who have already been diagnosed with chronic heart failure, it applies to a niche market and would come one or two steps after the PLAC test in the increasingly useful arsenal of cardiovascular diagnostic tests available to physicians. We do not see it as a direct or indirect competitor to the PLAC test.
    Sep 10, 2013. 01:46 AM | Likes Like |Link to Comment
  • Zohydro - Is There Enough Upside For Zogenix? [View article]
    TheOpioidTruth, thank you for your comment. We have found that there is conflicting evidence on the likelihood of FDA approval. We agree that the primary issue with Zohydro is the lack of effective abuse deterrents, however we chose to remain neutral on whether the FDA would approve Zohydro or not. What we are saying is that, either way, Zogenix is in a tough spot; if Zohydro is not approved, they will certainly need to make some changes, up to and including partnership, dilution, or possibly selling the company.
    May 2, 2013. 11:52 PM | Likes Like |Link to Comment
  • Zohydro - Is There Enough Upside For Zogenix? [View article]
    TheOpiodTruth, thank you for your comment. Sorry for any confusion. The comment about Purdue Pharma was in relation to this report. The confusion with the connection to Acura may have been due in part to this report concerning the same topic, which states: “The FDA approved labeling for a new formulation of OxyContin by Purdue Pharmaceuticals L.P. and this only enhances Acura's proprietary Aversion technology.” Thank you for pointing this out, we aim to provide as accurate data as we can.
    May 2, 2013. 11:52 PM | Likes Like |Link to Comment
  • OXiGENE's Oncology Drugs Have Run Their Course [View article]
    The authors failed to mention that OXiGENE bought back Symphony Capital's stock in 2009. Symphony Capital has not made subsequent investments in OXiGENE, and is still a major shareholder at this time.
    We apologize for this error.
    May 2, 2013. 07:35 PM | Likes Like |Link to Comment
  • Zohydro - Is There Enough Upside For Zogenix? [View article]
    Here is the link to the AdCom meeting transcript: http://1.usa.gov/ZYEHPW
    May 2, 2013. 07:03 PM | Likes Like |Link to Comment
  • Zohydro - Is There Enough Upside For Zogenix? [View article]
    Hi crimsonbey, thanks for your comments. Yes, the $9/pill price is an estimate. It's based on the average prices of all other ER/LA opioids in the market. We are making the assumption that the company will price the drug based on this average.

    As for the DEA quota, that is decided between the company and the DEA each year, but Zogenix claimed to the FDA Advisory Committee (AdCom meeting transcript, p122-3 and p322-3) that it would not increase its output faster than 20% per year. If they get approval, they have more options to finance/partner. However, they may soon face competition from the crush-resistant formulations currently in clinical trials, which will affect those decisions as well.
    May 2, 2013. 07:02 PM | Likes Like |Link to Comment
  • Osiris Therapeutics On The Brink: Products Failing To Deliver [View article]
    Thank you! Please spread the word so we can reach more followers.
    Mar 11, 2013. 03:00 AM | Likes Like |Link to Comment
  • Response Genetics' Competitors: Who To Watch, Who To Worry About [View article]
    The link to the above statement didn't post:
    "the company can now reliably detect germline variants and tumor specific mutations when the patient's blood sample is not available."

    http://bit.ly/15LVJmH
    Feb 26, 2013. 01:18 AM | Likes Like |Link to Comment
  • Response Genetics' Competitors: Who To Watch, Who To Worry About [View article]
    Zaguito,
    Glad you appreciated the article. In our opinion, Genomic Health is deserving of its own article, particularly following its earnings report and recent news about further development of proprietary next generation sequencing technology related to DNA strand-of-origin information. From our perspective, the fact that "the company can now reliably detect germline variants and tumor specific mutations when the patient's blood sample is not available" is quite interesting news.

    While it's difficult to estimate the impact of this finding on their future revenues and stock price, it is certainly a great selling point that builds upon their core expertise and shows that they are continuing to solidify themselves as a strong player in the realm of patient specific cancer diagnostics by utilizing the latest research tools and techniques. Also, as discussed in our article above, the trend seems to be that companies (like Genomic Health) that provide tests which predict a particular patient's response to a particular treatment are in a relatively protected niche that remains strong despite larger players (like Quest) coming in, aiming to eat away at the market share of existing diagnostic companies.

    We are aiming to delve deeper into diagnostics, so keep an eye out for our future articles.
    Feb 26, 2013. 12:58 AM | Likes Like |Link to Comment
  • Osiris Therapeutics On The Brink: Products Failing To Deliver [View article]
    Thanks for your comment. There is a significant amount of uncertainty involved in any kind of financial prediction. We have tried to be as objective as possible, and have voiced our opinions in this report based on careful due diligence of Osiris.
    Feb 25, 2013. 06:36 PM | Likes Like |Link to Comment
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