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Melon4head

06/27/17 4:58 PM

#5642 RE: FDApproved #5641

Actually "Open Label" has nothing to do with "Time" to completion of study. In this type of study- the active drug and/ or placebo is known by both the patients and clinicians. However, studies have been known to close early on positive or negative results if the data is overwhelming when compared to placebo.


According to Wikipedia" "An open-label trial or open trial is a type of clinical trial in which both the researchers and participants know which treatment is being administered".

Let's Hope the data is overwhelming in a positive way!

SrdghJack

06/29/17 10:56 AM

#5649 RE: FDApproved #5641

Allo/FDA:

You recently stated that "Yaky Said In A Recent Interview That They Intend To "Flood" The FDA With Efficacy Data From Multiple Sources..." which interview are you referring to? I could not find where he uses the word "flood" in reference to R18 data for the FDA