KZA 0.00% 8.0¢ kazia therapeutics limited

Pivotal Trial

  1. RBx
    643 Posts.
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    Nice lift in the SP after the trading halt was lifted, but not as much as one might have expected.

    It is clear that 0084 crosses the BBB and has a beneficial effect, so I wonder whether some investors are considering the time it will take to start a registration trial; and what such a trial will involve. Perhaps those in contact with James will be able to answer those questions?

    My guess is that the FDA will require a signed study report for both parts of the current trial before it would approve commencement of a pivotal trial. It is ironic that the better the result, the longer it takes for a trial to complete, so it might be some time before we reach that position.

    This should not alarm shareholders, providing they take a medium-term view. If the drug achieves FDA approval, it will not matter how long it takes.
 
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