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Re: XenaLives post# 256622

Sunday, 06/28/2020 11:35:46 AM

Sunday, June 28, 2020 11:35:46 AM

Post# of 515612
What we're looking for, and all biotechs, pharma, researchers, and regulators look for, is a therapeutic effect that is above control (historical SOC or placebo) and is statistically significant.

Make sure you understand therapeutic effect and statistical significant. And don't confuse the two.

An experimental drug can have a few results above 2 SD in a large trial. That is apparent effect. But it may not be stat sig. Another drug can have no such outcomes, but the results are stat sig (ie, the trial confidently showed there was no effect). Neither gets approved. But if a drug has enough response signal, in magnitude and volume (size of response and # of patients), it can be deemed therapeutically effective and stat sig. They're both necessary.

You're hoping we just need to have a few folks who did much better than placebo to get approval. That's incorrect. And it's called bad medicine and bad drug regulation and is something to be avoided. Don't let the fact that you own shares in something cloud your judgement. Be wary of confirmation bias.
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