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Theodore Cohen

 
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  • Dendreon: The Challenge Of Misinformation [View article]
    Why not educate yourself by running these two sites (or other similar sites) in the background on your computer?:

    www.cnbc.com/

    www.bloomberg.com/

    Good luck.

    Ted
    Aug 30 11:16 AM | Likes Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    Can we stick to the subject here, Aubug? The last time I saw someone using the technique of attacking their opponents because they couldn't respond 'on-topic' was in high school...in Debating 101, to be exact. (It's an old tactic...and one everbody sees through.)
    Aug 30 10:19 AM | 1 Like Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    Robert, the original wording of the second question at the Provenge Advisory Committee meeting of March 29, 2007, was inconsistent with federal guidelines. That was made perfectly clear during the meeting, and you know that. Further, the final data set met the FDA's requirements as set forth in the agreement between the company and the FDA following the AC. You are grasping at straws. The method by which the efficacy was proven is well accepted by the community.
    Aug 30 10:08 AM | Likes Like |Link to Comment
  • Vical: Making Progress In The Area Of HSV-2 Vaccines [View article]
    Must have been my odd-lot share purchase on the opening this morning that kicked things off (not! LOL). But the stock had been approaching oversold territory, so a rebound when the markets turned positive was in the cards.

    Take a look here:

    stockcharts.com/h-sc/ui

    Put the URL above in your browser and enter VICL. Look at the daily chart. The 50-cay MACD line (black line, lower of the three graphs), is just about to punch through the 200-day line (red), suggesting that the 'smart' money is coming back into the stock. Resistance is a roughly $4.20, which it must get through to begin a new upleg.

    The volume is nice today, but certainly not anything to suggest a major move...just nice and steady on the upside. More of a technical move, I think.

    Thanks for your interest.

    Ted
    Aug 29 03:49 PM | Likes Like |Link to Comment
  • Dendreon and Fuzzy Journalism: Wherein lies the truth? [View instapost]
    Ahhh, Dear ahasuerus99...

    My piece was intended to address the issue of 'fuzzy journalism' and those in the media who either simply take their stores from others without understanding what they are writing or who do not understand how to interpret the data or information about which they are writing. It was Mr. Denninger who made the decision to change the topic of our discussion to one of price and who is to be treated (or not). Simply because I have decided not to refute Mr. Denninger's point says absolutely nothing about the position I may, or may not, take on the subject. Are you always in the habit of speaking for others?

    But if you want an answer from me, here it is: Provenge, approved by the FDA, was subsequently approved by the CMS for end stage prostate cancer. On August 3, 2011, CMS published a National Coverage Determination (NCD) that clarifies reimbursement of PROVENGE for Medicare beneficiaries. A final J-Code will be issued January 1, 2012. As long as CMS and other insurance providers pay for the administration of Provenge, Taxotere, or any other medication for prostate cancer or any other disease--be that insurance Medicare, Medicaid, Blue Cross/Blue Shield, or any other insurer--then what you, Mr. Denninger, or I think doesn't matter, does it? It's the law. And while we each can have an opinion, and certainly, are free to voice it in fora such as Seeking Alpha and elsewhere on the Internet, in the end these reimbursement policies are not going to change without action at the federal level.

    Thanks for your comments.

    Ted
    Aug 29 03:09 PM | 1 Like Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    Roberto, here's a good tutorial on Provenge for those interested in how the treatment works.

    vimeo.com/28112783

    It's presented by the Lexington Medical Center. What is it about Provenge, as describe here, and please, be precise, that does not meet your standards of credible science?

    Ted
    Aug 29 12:11 PM | Likes Like |Link to Comment
  • Dendreon and Fuzzy Journalism: Wherein lies the truth? [View instapost]
    Good point, GW! David Miller showed that when you take into account the treatment of Taxotere's side effects, the cost of treating end stage prostate cancer with either Taxotere or Provenge is about the same.

    minyanville.com/bu...

    Here are the details:

    Taxotere Side Effects:

    Important things to remember about Taxotere side effects:
    •Most people do not experience all of the Taxotere side effects listed
    •Taxotere side effects are often predictable in terms of their onset and duration
    •Taxotere side effects are almost always reversible and will go away after treatment is complete
    •There are many options to help minimize or prevent Taxotere side effects
    •There is no relationship between the presence or severity of Taxotere side effects and the effectiveness of Taxotere.
    •Taxotere side effects and their severity depend on how much Taxotere is given. In other words, high doses of Taxotere may produce more severe side effects).

    The following Taxotere side effects are common (occurring in greater than 30%) for patients taking Taxotere:
    •Low white blood cell count (this can increase your risk for infection)
    •Low red blood cell count (anemia)

    Nadir: Meaning low point, nadir is the point in time between chemotherapy cycles in which you experience low blood counts.

    Onset: 4-7 days
    Nadir: 5-9 days
    Recovery: 21 days

    Fluid retention with weight gain, swelling of the ankles or abdominal area.


    Peripheral neuropathy (numbness in your fingers and toes) may occur with repeated doses. This should be reported to your healthcare provider.

    •Nausea
    •Diarrhea
    •Mouth sores
    •Hair loss
    •Fatigue and weakness
    •Infection
    •Nail changes (color changes to your fingernails or toenails may occur while taking Taxotere. In extreme, but rare, cases nails may fall off. After you have finished Taxotere treatments, your nails will generally grow back.)

    These Taxotere side effects are less common, meaning they occur in 10-29 percent of patients receiving Taxotere:
    •Vomiting
    •Muscle/bone/joint pain (myalgias and arthralgias)
    •Low platelet count (This can increase your risk of bleeding)
    •Increases in blood tests measuring liver function. These return to normal once treatment is discontinued. (see liver problems)

    Infusion-related Taxotere side effects (symptoms which may occur during the actual treatment) include:
    •Allergic reactions (rash, flushing, fever, lowered blood pressure). Happens rarely, usually occurs in the first or second infusion. Frequency is reduced by premedication with corticosteroid starting one day before infusion. You will be monitored closely during the infusion for any signs of allergic reaction.
    •Infusion site reactions (uncommon and generally mild, consist of darkening of the vein, inflammation, redness or dryness of the skin, or swelling of the vein).

    Not all Taxotere side effects are listed above, some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

    Compare that to the side effects from Provenge:

    Side Effects of Provenge - for the Consumer

    Provenge

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Provenge:


    Back pain; fatigue; headache; joint aches; mild pain, fever, or chills; nausea; weakness.
    Seek medical attention right away if any of these SEVERE side effects occur when using Provenge:

    drugs.com/sfx/prov...

    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; chest pain; confusion; fatigue; fast or irregular heartbeat; fever, chills, or sore throat; muscle spasms or aches; one-sided weakness; redness or pain at the injection site; severe joint aches; severe muscle pain, weakness, or cramping; severe or persistent dizziness, headache, or nausea; shortness of breath; slurred speech; tremors; unusual tiredness or weakness; vision problems; vomiting.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    What would you chose if you had end stage prostate cancer and no other alternatives? I know what my choice would be.

    Or are we about to enter an age when for every disease, a panel not only will decide which treatment will be provided, but which patients will live and which will die. Is this the World of 2084?
    Aug 29 12:04 PM | 4 Likes Like |Link to Comment
  • Dendreon and Fuzzy Journalism: Wherein lies the truth? [View instapost]
    Ah, a slippery slope, indeed, my friend.

    An associate sent me the following comment shortly after you penned your screed: "Suppose, shortly after he wrote that article, he suffered massive chest pains. Emergency procedures lead him to the OR and a possible triple bypass. Estimated costs: $60,000 to $120,000. Is he going to pay for it or refuse it?"

    I didn't know what to say?
    Aug 29 11:26 AM | Likes Like |Link to Comment
  • Dendreon and Fuzzy Journalism: Wherein lies the truth? [View instapost]
    Thanks for your comment. Ted
    Aug 29 11:22 AM | Likes Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    Just for grins, the new, average net worth of the neighborhood, by the way, is just over $4 billion per household...which of course, is nowhere near the truth.
    Aug 29 11:02 AM | Likes Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    I agree...the math associated with averages and medians is very simple.

    Take this interesting example:

    There is a neighborhood in Seattle with 14 homes. The net worth of the fourteen homes (in millions) is shown below:

    3, 5, 7, 12, 13, 14, 21, 23, 23, 23, 23, 29, 40, 56

    In this example, the middle numbers are 21 and 23. To find the value half-way between them, add them together and divide by 2:

    21 + 23 = 44
    44 ÷ 2 = 22

    Thus, the median net worth is $22 million.

    (see www.mathsisfun.com/med... for more details; this was a bit more complicated because we dealing with an even number of values.)

    The average net worth for this neighborhood is simply the sum of the values divided by 14, or $20.86 Million, just slightly less than the median, but in the same ball park.

    Now, let's say that Bill Gates moves into the neighborhood. Mr. Gates has a net worth arguably $56 BILLION

    www.billgatesmicrosoft...

    3, 5, 7, 12, 13, 14, 21, 23, 23, 23, 23, 29, 40, 56,000

    And, so, the Median in this example still is 22 (or $22 million). But the average is blown out of the water...it's something close to $56 Billion.

    So, after Bill Gates moves into the neighborhood, which number is more representative of the people who live there? The median of $22 million, or the average, which is now something closer to Bill Gates net worth? Clearly, it's the former ($22 million).

    The fact is, those working with Taxotere and Provenge can easily compare the relative median life extensions and the side effects associated with these two treatments and come to decisions that are in the best interests of their patients.
    Aug 29 10:55 AM | Likes Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    Robert, with all due respect, it does "work." The FDA says it does, or they would not have granted approval.

    If your looking for more overt signs of disease regression as might be produced by chemo, then you'll have to be prepared not only for a lesser median life extension, but also, a plethora of horrific side effects:

    www.chemocare.com/bio/...

    Taxotere Side Effects:

    Important things to remember about Taxotere side effects:
    •Most people do not experience all of the Taxotere side effects listed
    •Taxotere side effects are often predictable in terms of their onset and duration
    •Taxotere side effects are almost always reversible and will go away after treatment is complete
    •There are many options to help minimize or prevent Taxotere side effects
    •There is no relationship between the presence or severity of Taxotere side effects and the effectiveness of Taxotere.
    •Taxotere side effects and their severity depend on how much Taxotere is given. In other words, high doses of Taxotere may produce more severe side effects).

    The following Taxotere side effects are common (occurring in greater than 30%) for patients taking Taxotere:
    •Low white blood cell count (this can increase your risk for infection)
    •Low red blood cell count (anemia)

    Nadir: Meaning low point, nadir is the point in time between chemotherapy cycles in which you experience low blood counts.

    Onset: 4-7 days
    Nadir: 5-9 days
    Recovery: 21 days

    Fluid retention with weight gain, swelling of the ankles or abdominal area.


    Peripheral neuropathy (numbness in your fingers and toes) may occur with repeated doses. This should be reported to your healthcare provider.

    •Nausea
    •Diarrhea
    •Mouth sores
    •Hair loss
    •Fatigue and weakness
    •Infection
    •Nail changes (color changes to your fingernails or toenails may occur while taking Taxotere. In extreme, but rare, cases nails may fall off. After you have finished Taxotere treatments, your nails will generally grow back.)

    These Taxotere side effects are less common, meaning they occur in 10-29 percent of patients receiving Taxotere:
    •Vomiting
    •Muscle/bone/joint pain (myalgias and arthralgias)
    •Low platelet count (This can increase your risk of bleeding)
    •Increases in blood tests measuring liver function. These return to normal once treatment is discontinued. (see liver problems)

    Infusion-related Taxotere side effects (symptoms which may occur during the actual treatment) include:
    •Allergic reactions (rash, flushing, fever, lowered blood pressure). Happens rarely, usually occurs in the first or second infusion. Frequency is reduced by premedication with corticosteroid starting one day before infusion. You will be monitored closely during the infusion for any signs of allergic reaction.
    •Infusion site reactions (uncommon and generally mild, consist of darkening of the vein, inflammation, redness or dryness of the skin, or swelling of the vein).

    Not all Taxotere side effects are listed above, some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

    Compare that to the side effects from Provenge:

    Side Effects of Provenge - for the Consumer

    Provenge

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Provenge:


    Back pain; fatigue; headache; joint aches; mild pain, fever, or chills; nausea; weakness.
    Seek medical attention right away if any of these SEVERE side effects occur when using Provenge:

    www.drugs.com/sfx/prov...

    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; chest pain; confusion; fatigue; fast or irregular heartbeat; fever, chills, or sore throat; muscle spasms or aches; one-sided weakness; redness or pain at the injection site; severe joint aches; severe muscle pain, weakness, or cramping; severe or persistent dizziness, headache, or nausea; shortness of breath; slurred speech; tremors; unusual tiredness or weakness; vision problems; vomiting.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    David Miller showed that when you take into account the treatment of Taxotere's side effects, the cost of treating end stage prostate cancer with either Taxotere or Provenge is about the same.

    www.minyanville.com/bu...

    What would you chose if you had end stage prostate cancer and no other alternatives? I know what my choice would be.
    Aug 29 10:25 AM | 5 Likes Like |Link to Comment
  • Vical: Making Progress In The Area Of HSV-2 Vaccines [View article]
    I'm sorry...I don't follow that CLDX. Ted
    Aug 29 09:18 AM | Likes Like |Link to Comment
  • Dendreon: The Challenge Of Misinformation [View article]
    Saul, readers interested in more on the life-extension benefits to Provenge may find the information and references in my just-posted Instablog of interest:

    seekingalpha.com/insta...

    Ted
    Aug 29 07:41 AM | 1 Like Like |Link to Comment
  • Vical: Making Progress In The Area Of HSV-2 Vaccines [View article]
    Thanks for your comments.

    BMY certainly could be come a suiter, though Vical's Japanese partner might also be expected to bid on any potential buyout if AV-7 lives up to expectations.

    Regarding Medarex, Ipi's results were just short of what was needed for that drug to be labled a 'sure thing' for approval (or at least the closest thing to that with the FDA). So, BMY took some risk in purchasing the company. That said, a review of the historical relationship between BMY and FDA/CDER/ODAC (specifically, Dr. Richard Pazdur) might lead one to conclude that the 'fix' was in. But don't get me started!
    Aug 29 07:31 AM | Likes Like |Link to Comment
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