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Re: XenaLives post# 10255

Sunday, 05/05/2019 1:46:48 PM

Sunday, May 05, 2019 1:46:48 PM

Post# of 21540
Yes, the FDA has no problem with a company running different types of trials. What really counts is what you can ascertain from those trials.

The last 2-73 trial matches closest to "5. External Control (Including Historical Control) (1.3.5)"

From your link:

"External (historical) control groups...are considered together as the fifth type because of serious concerns about the ability of such trials to ensure comparability of test and control groups and their ability to minimize important biases, making this design usable only in unusual circumstances."

Everyone here has been saying the same thing--serious concerns about 2-73 results, since there is no way to minimize or eliminate biases.
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