ATH 0.00% 0.3¢ alterity therapeutics limited

watching closely, page-74

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    groins, I'm not expecting an extension to the REACH2HD trial for several reasons:
    1. One of the major benefits of extending a trial is to demonstrate safety and tolerability over a longer period. The IMAGINE trial already has patients who have been dosed with PBT2 over 12 months (the longest on the REACH2HD trial is 6 months).
    2. The REACH2HD trial is the first human trial (Ph IIa) for PBT2 targeted at HD. I don't think it would be smart to extend the trial unless you were very confident that the settings (dose, hypothesis, etc) are optimal. It would be amazing to get all that correct in the initial human trial.
    3. I'm working on the basis that the extended IMAGINE trial is providing additional data to provide more comfort about a fast-track FDA approval of PBT2 for AD. This isn't likely for HD off the back of a short Ph IIa trial.

    All just my speculation! Good luck all...

 
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