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I agree with ST. the whole point of the recent trial was that...

  1. 494 Posts.
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    I agree with ST. the whole point of the recent trial was that the original small open label trial was exactly that, small and open label. this was not sufficient for the ema nor for prospective partners and Is exactly the reason a larger blInded trIal was requIred to test the products efficacy.

    as to how it could "suddenly" fail, this was a blinded trial so nobody would have been in a position to know what the outcome was going to be during the running of the trial. the management themselves would only have been given the results earlier this week (and definitely a week I am sure they haven't enjoyed either).

    prior to that they rightly proceeded on the basis that the trial would be a success, engaging TC to liaise with potential partners and doing prep works for the next stage VLU as well as other indications.

    I have no doubt that they will currently be going through post analysis in more detail to try to establish what happened and if there was any kind of error that could have occurred along the way, but I am also sure the trial would have been carefully run. they may or may not publish additional post analysis info, but they had to communicate the top line results once they had them, and i feel like they have given us as much as they currently could know for the moment.

    was a bit disappointing to see that even in spite of the two week screening period the placebo group dropped by more than 30% wound size within the first two weeks of the actual trial, but none of the rest of the data stands out regardless.

    again I feel for those who had a lot riding on it, our thoughts are with you
 
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