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China Housing and Land Development, Inc. Message Board

acorisk 5 posts  |  Last Activity: Oct 2, 2015 4:49 PM Member since: Jan 6, 2011
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  • acorisk acorisk Oct 2, 2015 4:49 PM Flag

    Pipeline is worth significantly more than the voucher. The voucher comes as a freebie once the FDA approves the skin in peds for a rare indication (the pediatric nevus indication).

    Think of pipeline as $X billions (ESS, Elt. and MANF) and the voucher as the frequent flier points ($250 million). Great move - using incentives available to get more for something you were going to do anyway.


  • Reply to

    ESS In China - Chinese Partner?

    by ambs_informant Oct 2, 2015 9:12 AM
    acorisk acorisk Oct 2, 2015 10:15 AM Flag

    doesn't matter if the country cares about it -- only if the banker cares about it as a financial partner. Bank of China looking for diversification into US assets.

  • The pediatric voucher program (FDA priority review voucher extension that became law in 2012) includes several changes that had been sought for the neglected-disease voucher program, but apply only to pediatric vouchers. MAKES THE VOUCHER MORE VALUABLE than for neglected disease PVR voucher. A key part - can be sold multiple times (think AMBS sells it quickly to a capital partner who buys it at a discount and then sells to Pharma).

    First, the pediatric treatment developer can ask the FDA in advance for an indication of whether the disease qualifies as a rare, pediatric disease. Second, the pediatric voucher can be transferred an unlimited number of times, whereas the neglected-disease voucher can only be transferred once. Third, the pediatric voucher user needs to notify FDA 90 days prior to using the voucher, rather than 1 year for the neglected-disease voucher. Fourth, the pediatric voucher winner risks having the voucher revoked if the treatment is not marketed within a year. Fifth, the pediatric voucher winner must report to FDA about use of the pediatric treatment within five years of approval.

  • $250 mm ---- Priority review voucher = $250 million in cash in sale to big pharma if received
    $ ESS (engineered skin) - burns.
    $ ESS - vascular wounds (Diabetic ulcers -- they haven't spoken about it but huge opportunity)
    $ Eltoprazine --- Parkinsons + ADHD
    $ MANF - Retinal (with a drug that stops cells in general from dying -- Heart attack, Alz other)
    $ Diagnostic division
    $ NASDAQ uplisting (impact on share price stability and investor pool)
    $1 billion = 100x current value. Could easily end up more.
    @$50 million this was a good deal. @$10 million - 5x gets it back to where it was recently as a good deal!


  • Economists at Duke University, who published on this concept [Priority Review Voucher] in 2006, estimated that priority review can cut the FDA review process from an average of 18 months down to six months, shortening by as much as a full year the time it takes for the company’s drug to reach the market.[1]

    For a company with a top selling drug with a net present value close to $3 billion, the Duke researchers calculated the accelerated approval could be worth over $300 million

    ESS could earn one of these if it gets the pediatric Nevus designation

2.48Oct 5 3:57 PMEDT