PER 5.00% 10.5¢ percheron therapeutics limited

Ann: ATL1102 tox study to support clinical program in the US, page-39

  1. 4,361 Posts.
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    Boomy,

    Have a read of this This suggests that the human 6 month dosing will end around the same time as the tox study, and both sets if results will be presented to the FDA around the samd time.

    The phase 2b trial will be EU and TGA based, so doesn't need the tox study to continue high dosing beyond 6 months. So, with the plan of using this data to facilitate FDA approval, its more a paperwork exercise to ensure FDA requirements are met so as to not compromise results.

    If dosing was in FDA land it would be as you suggest, need to pass the tox study trial before continuing beyond 6 month human dosing.
 
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