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Clinuvel, de droom van elke belegger......

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  1. [verwijderd] 4 september 2007 07:19

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    Van het Sharescenforum:

    The Australian
    4 September 2007

    BIOTECH companies are selling a vision more than anything, so we shouldn't be shocked they've been trashed by a market looking for hard cash, not fuzzy dreams.

    Yet results from advanced drug developers usually have been encouraging, such as Pharmaxis's "stunningly successful" trials of its lung disorder drug Bronchitol.

    Skin disorder group Clinuvel has been hammered, despite launching phase-three trials to test two uses for its photo-protective compound CUV1647.

    The disorders are sun poisoning and absolute sun intolerance. The latter is fortunately rare, affecting 30,000-40,000 people globally.

    Sufferers are called "shadow chasers" in that they can't leave their home in direct sunlight.

    Clinuvel is still trying to divest itself of the more frivolous image of its former guise EpiTan, which aimed to perfect a fake tan.

    Mention such cosmetic applications to new CEO Philippe Wolgen and chairman Roger Aston and they'll grimace.

    In reality, though, Clinuvel's targeted sectors are very small so the company needs to find a wider application to make the game worthwhile.

    The most obvious is a preventative drug for skin cancer. To this end, Clinuvel is working on phase-two trials involving kidney transplant patients, who have a high chance of dying from skin cancer.

    But a non-therapeutic application could well emerge as the biggest market -- and we're really talking about a safe, fake tan. After all, CUV1647 is all about darkening the skin by producing more melanonin, which boosts the skin's immunity to harmful rays.

    There's a classic precedent here: the frown-numbing Botox was first developed as an eye anaesthetic for a niche market.

    Given the recent publicity about the dangers of solariums and moves to tighten industry regulation, Clinuvel might be able to hit more than one bullseye with the one stone.

    The downside is that Clinuvel holds only one stone, with little else in development beyond CUV1647.

    "We're working on the one drug, but one drug with the safety of multiple potential applications," Wolgen says.

    Clinuvel reported a $9.17 million loss for the year to June 30, on revenues of $2.5 million.

    Clinuvel has cash of $62 million after tapping investors earlier this year, and shouldn't need more.

    According to broker Intersuisse, the stock has declined "simply due to a shift in the global perception of risk and capital to more conservative assets".

    Criterion rates Clinuvel a hold, after last assigning an avoid at 83c in early February. The stock leaped 10c, or 12 per cent, yesterday.

    Clinuvel is firmly on track, but its share price will remain vulnerable to poor news or, indeed, no news. As Wolgen notes, investing in biotechs at drug development requires more than skin-deep faith.

  4. frank2you 4 september 2007 16:55

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    De terugval in Duitsland valt mee in vergelijking tot Australie.... vanacht zal de ASX een positieve correctie laten zien waarna we na lange tijd deze maand in duitsland de €0,60 weer kunnen gaan aantikken.
  6. [verwijderd] 5 september 2007 11:53

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    quote:

    Yzord schreef:

    lol, nogmaals, geen nieuws, geen stijgingen...dus die 60 raken we voorlopig nog niet.
    gisteren net op 0,49 gekocht als ie binnekort geen grote stijgingen gaat maken misschien nog even bijkopen
  8. [verwijderd] 6 september 2007 06:44

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    Gezondheidswaarschuwing v/d FDA. Illegale verkoop van Melanotan II op de US markt door Melanocorp. Dit is weliswaar bekend maar toch slecht voor de image van Clinuvel, denk ik zo.

    FDA News
    FOR IMMEDIATE RELEASE
    September 5, 2007
    Media Inquiries:
    Rita Chappelle, 301-827-6242
    Consumer Inquiries:
    888-INFO-FDA

    FDA Issues Warning Letter to Melanocorp, Inc. For Illegal Sale of Melanotan II
    Agency warns consumers about using and purchasing unapproved product
    The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Brian Manookian, owner of Melanocorp, Inc. in Hendersonville, Tenn. for the illegal sale and marketing of the product Melanotan II, which is not FDA-approved, on Melanocorp's Web site. FDA recommends that consumers who are currently using Melanotan II stop using this product and consult their health care provider if they have experienced any adverse events that they suspect are related to its use.

    "This product is being mislabeled, marketed and sold illegally as a preventative against skin cancer and as a tanning agent," said Steven Galson, M.D., M.P.H. director of FDA's Center for Drug Evaluation and Research. "Protecting the public from unapproved products such as this that make unsubstantiated claims and may pose a health risk is a top priority at the FDA."

    Melanocorp, Inc. advertises the product Melanotan II on its Web site as an injectable tanning product, with additional claims that it is effective in protecting against skin cancer and rosacea (a flushing and redness of the skin). These claims cause Melanotan II to be classified as a drug under the Federal Food, Drug and Cosmetic Act, as well as a new drug because there is no evidence that it is generally recognized as safe and effective for its labeled uses. This product does not have an approved new drug application, and the product's Web site makes false and misleading statements. The product's introduction and delivery into interstate commerce, therefore, violates federal law. The risks run by patients who use unapproved new drugs could include adverse side effects from inappropriately prescribed medications, dangerous drug interactions, and harm from contaminated, counterfeit or outdated drugs. The FDA cautions consumers about injecting any substance, particularly products that are not FDA-approved, into their bodies without the oversight of a licensed health care provider.

    Issuance of this Warning Letter is consistent with FDA's focus on fraudulent products marketed on the Internet for serious and life-threatening diseases. Individuals and firms that do not resolve violations of the Federal Food, Drug, and Cosmetic Act risk injunction to halt the illegal activities, seizure of violative products, and other regulatory sanctions.

    Consumers and health care providers should notify FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, FDA's voluntary reporting program, by phone at 1-800-FDA-1088, or online at www.fda.gov/medwatch/report.htm.

    www.accessdata.fda.gov/scripts/wlcfm/...
  10. [verwijderd] 6 september 2007 09:01

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    nah neee.... dit gaat over de illegale praktijken van de melanotan II. De toepassing in vergelijking met de toepassing die clinuvel gebruikt is ook totaal anders......

    Het is gewoon van de gekke dat je iets gaat verkopen zonder goedkeuring van de fda...je speelt met iemand zijn gezondheid.... een goede stap van de fda.je moet mensen niet iets gaan verkopen waar de onderzoeken nog niet van zijn afgerond ( melanocorp is volgens mij helemaal daar niet mee bezig)

    Nogmaals m.i. geen invloed op clinuvel...maar er zullen altijd enkele ezels zijn die hierop gaan verkopen....nog maar eens een diepteordertje inzetten maar;-)

  18. svenhedin 10 september 2007 09:12

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    quote:

    controverse schreef:

    al gelezen?

    site Clinuvel
    7-Sep-2007
    Appendix 3Y
    Kun je mij uitleggen of en zo ja waarom er verband is met de koersdaling ?
  20. frank2you 10 september 2007 09:59

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    Spannende dagen op alle beursen..... Een potentieele aanval op Iran.... evt. val van de dollar.....en clinuvel doet lekker mee....terug op 40 eurocenten.
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