What on earth are you talking about Bedger?! You're making as much sense as a Recce announcement.
You're claiming that Recce disagree with the statement they published in their own slide deck about international regulators?! Are you saying Indonesia are not an "international regulator"?! Or are they unethical?
If you listened to the webinar, they use that statement as a defence of why they had no control arm in their P2.
But the reason you're confused is because, as usual, Recce are being vague and misleading. Of course a true, strict placebo-control is unethical and irrelevant in the vast majority of trials for the vast majority of conditions. That goes without saying.
But it is why either an active-control, or a placebo add-on design, is used as a control arm. Either one of which should have been used in their P2.
And a placebo add-on is what is being used in their P3, surely? Maybe? Who knows. Because Indonesia is basically uncharted territory I have no idea where or how prototcols are published and tracked.
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