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Exelixis, Inc. Message Board

  • buysignalinvestments buysignalinvestments Nov 21, 2012 3:47 PM Flag

    You have not seen anything yet...

    Those naked short, are going to scramble. They can eat Turkey all day tomorrow, and it will change nothing as this heads to $12.IMO Only chance are short term trader pull backs, but the demand for stock is growing without any short covering. Bad news for shorts. Cover now or do so way higher.IMO

    Sentiment: Strong Buy

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    • If you are short, and not hedged, you are about to get destroyed.IMO Things are just warming up here. The main events unfold over the next 6 months, will lead to big double digit price. IMO Lets see who has had this right. I am holding for at least another year, in any case. I see VERY good chance of $20 plus within months. Why? As people realize that Cabo works big time for Prostate Cancer, all else will be secondary. Takeover or price has to move much higher. Big Pharma NEEDS new drugs, this is an obvious target. But they will have to pay, as EXEL owns it all and does not have any cash needs. EOS

      Sentiment: Strong Buy

    • Buysignal,
      Aside from the potential squeeze. Do you have any idea, assuming approval for MTC, if patients suffering from bone mets can obtain Cabo, which would be an off label indication?

      Sentiment: Buy

      • 3 Replies to w.capron
      • The reality is that as noted above, licensed drugs can be used/prescribed off label. However, while such drugs can be prescribed, they may not be promoted (i.e. advertised in medical journals or in the general media or even social media) as having a proven benefit in the off-label indication. I suspect that by generating excitement in the KOL community, there might be some word of mouth prescribing. The next barrier is reimbursement. Third-party payors, be it private insurers or more likely Medicare for prostate cancer, will need to decide whether to reimburse. That hurdle may be harder to overcome as there is an argument to be made (valid IMO) that evidence of benefit has not been robustly demonstrated fora specific population in prostate cancer patients. Ultimately, we need to have the safety profile along with a robustly characterized efficacy effect to be able to weigh benefit vs. risk. However, if I'm wrong and everyone is ready to prescribe it off-label and get it paid for and EXEL stock rises signifcantly, that will be just fine with me, I'm just not expecting that until we start to get the COMET data.
        For now, let's wait for the anticiapted initial approval and hope that does something to the PPS.

        GLTA and Happy Thanksgiving,

        The "Wiz"

      • Here are some of the facts in the U.S. regarding "Off Label Use"
        Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration. In the United States, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) reviews a company's New Drug Application (NDA) for data from clinical trials to see if the results support the drug for a specific use or indication. If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug's label. More detail is included in the drug's package insert.
        The FDA approves a drug for prescription use, and continues to regulate the pharmaceutical industry's promotional practices for that drug through the work of the Office of Prescription Drug Promotion (OPDP, formerly the Division for Drug Marketing, Advertisement and Communication (DDMAC) The FDA does not have the legal authority to regulate the practice of the medicine, and the physician may prescribe a drug off-label. Contrary to popular notion, it is legal in the United States and in many other countries to use drugs off-label, including controlled substances such as opiates.
        Off-label use of medications is very common. Generic drugs generally have no sponsor as their indications and use expands, and incentives are limited to initiate new clinical trials to generate additional data for approval agencies to expand indications of proprietary drugs.[1] Up to one-fifth of all drugs are prescribed off-label and amongst psychiatric drugs, off-label use rises to 31%.[7] Among use of antipsychotic medications in the United States, a shift occurred from typical agents in 1995 (84% of all antipsychotic visits) to atypical agents by 2008 (93%). Atypical use has grown far beyond substitution for the now infrequently used typical agents.[8] New drugs are often not tested for safety and efficacy specifically in children and even when they are tested, the results of these trials may not be disseminated to practicing physicians. A 2009 study found that 62% of U.S. pediatric office visits included off-label prescribing, with younger children at higher risk of receiving off-label prescriptions. Specialist physicians also prescribed off-label more frequently than general pediatricians.

        United States
        In the United States, no law prohibits a physician or other healthcare practitioner from prescribing an approved medication for other uses than their specific FDA-approved indications.[14] Pharmaceutical companies are not allowed to promote a drug for any other purpose without formal FDA approval. Marketing information for the drug will list one or more indications, that is, illnesses or medical conditions for which the drug has been shown to be both safe and effective.
        However, once a drug has been approved for sale for one purpose, physicians are free to prescribe it for any other purpose that in their professional judgment is both safe and effective, and are not limited to official, FDA-approved indications. This off-label prescribing is most commonly done with older, generic medications that have found new uses but have not had the formal (and often costly) applications and studies required by the FDA to formally approve the drug for these new indications. However, there is often extensive medical literature to support the off-label use.

        Sentiment: Strong Buy

      • That is the interesting question. I think it will go that way, because when you have no hope, and a drug that has been approved, it will be much easier to pressure for off indicated use. In any case, there will be huge value assigned, because the results look awesome for Prostate Cancer/ Bone Mets. It makes it a blockbuster, almost certainly on approval, and this is what will drive the price much higher than many think.IMO

        Sentiment: Strong Buy

8.68+0.09(+1.05%)Jul 22 4:00 PMEDT