AVH 9.09% 42.0¢ avita medical ltd

It is almost a given, they are rarely denied a patent in these...

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    It is almost a given, they are rarely denied a patent in these circumstances.

    In regards to 510K easier to post a link

    https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm

    The costs etc to do with having a "generic" ReCell are many especially with a device like ReCell much more than a medicine which is a simple formula. Molds for the device which are expensive to design, make and the testing of the device working the same, it's not as bad as all th full clinical trials etc, but, it's just a lot more money, risk etc for something where the majority of the US market will be closed to them. I don't see it being worth it.
    Last edited by Tdeck1966: 21/04/19
 
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