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Re: XenaLives post# 7757

Friday, 01/04/2019 11:20:23 PM

Friday, January 04, 2019 11:20:23 PM

Post# of 21540
What does grandma have to do with what I asked?

You said: "...and if 2/3 of the patients in the P2a start sleeping and feeling better they will get conditional approval without breaking the blind."

Conditional approval without breaking the blind???

Again, you have to break the blind to review the data to ensure there isn't a placebo effect. That's just common sense.

Breaking the blind before the final analysis is called an interim look, and it must be pre-specified in the trial protocol, and further it incurs a statistical hit to the final analysis.

If you can give a link to the description of this pre-specified interim look, then I guess we can discuss something. Otherwise, it's just wishful thinking.

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