MSB 2.04% $1.00 mesoblast limited

Question regarding JAPAN, page-2

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    I am sure Dialogue is on going with the FDA and Mesoblast once the first is greenlighted the others will follow suit .. I posted this some time back .............Japan’s new regulations regarding regenerative medicine are positive for the entire sector, so other companies are likely to explore their options in Japan, too. As Van Bokkelen says, “This will cause some companies to consider running trials in Japan or running truly international studies that include Japanese sites. It also creates the potential for a more efficient, less expensive path to market. That’s something all investors should really like.”
    SIMILAR U.S. PROVISIONS IN THE WORKS
    Improvements in the U.S. regulatory system have included some provisions that are similar to those of the Japanese regulations. The Prescription Drug User Fee Act (PDUFA-V), for example, includes a new “breakthrough therapies” designation and broadens the potential application of the accelerated approval pathways.
    Congress also is considering the 21st Century Cures Initiative. By taking a comprehensive look at the entire drug development process from discovery through development, commercialization, and delivery, Congress intends to find ways to streamline the process and bring life sciences products to market faster than is possible now.
    “This is at the discussion draft stage and has bipartisan support,” Van Bokkelen says. “I’m optimistic it will advance and will contain some important provisions to accomplish some of the same objectives as the Japanese legislation.”
    While U.S. efforts remain in discussions, Japan’s efforts are in effect now. By granting conditional approval, Japan delivers a path to reimbursement while trials are underway, demonstrating a commitment to bringing advanced regenerative medicine to its populace and to enhancing its standing as a destination that actively supports biotech innovation.........................................Call it fast tracking , accelerating, or quick to revenue, Some here said its not going to happen and that was 6 months ago plus .. ..My belief and has been for some years, reg.med will be fast tracked world wide , authorities wont wait for tens of thousands to die whilst waiting for many years for trials to be completed ...Cheers Vin
 
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