Friday, October 23, 2020 10:59:45 AM
True "we only know of 21 patients"... but perhaps these couple unofficial observations can help put some additional background to it...
- My understanding is the fda typically looks for a pval of P=<.001 (or maybe it was only P=<.01 if I recall - and I'm hoping someone can point us to an official source). Albeit a small sample, the 21 patients came in at P=<.0001, so quite a bit better.
- Remember when Javitt was discussing the 9-fold efficacy over soc, he also stated that there were more data they're seeing from the open label study and it is in line with the results from the 21. He seemed pretty certain the results are not the worlds largest placebo effect.
Sorry... I don't have all my facts and sources in front of me, but these are the points I do consider above the official info... given it comes from Javitt.
- My understanding is the fda typically looks for a pval of P=<.001 (or maybe it was only P=<.01 if I recall - and I'm hoping someone can point us to an official source). Albeit a small sample, the 21 patients came in at P=<.0001, so quite a bit better.
- Remember when Javitt was discussing the 9-fold efficacy over soc, he also stated that there were more data they're seeing from the open label study and it is in line with the results from the 21. He seemed pretty certain the results are not the worlds largest placebo effect.
Sorry... I don't have all my facts and sources in front of me, but these are the points I do consider above the official info... given it comes from Javitt.
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