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Re: Babaji post# 20103

Monday, 08/29/2022 7:04:31 PM

Monday, August 29, 2022 7:04:31 PM

Post# of 21540
It's meant to further inform the company about how to design the next trial rather than prove anything to the public or the FDA, hence no need for a placebo or statistical significance.

The current 20mcg dose is only used because it outperformed a 40mcg dose in 2017 and not because they found it to be the optimal dose.

They're only announcing topline data in December while full data will take at least another 4 months, so there's plenty of time for the open label trial to produce results before they launch a larger P3 trial based on those results.

There should be a link to a scientific paper in the ibox about their earlier compassionate use trial that show graphs of how they switched between different doses and intervals to see what works and what doesn't. Before that all they had was mouse data for efficacy and cancer patient data for safety.
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