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Re: Fred Kadiddlehopper post# 3202

Thursday, 06/19/2014 2:55:25 PM

Thursday, June 19, 2014 2:55:25 PM

Post# of 8484
Ummm, thanks for the STATS101 review, Fritz. Again (as stated), the main purpose of the study was to prove safety, which was considered successful enough to lead to two Phase II studies (in-spite of its low N value). Since we're discussing N and P values though, it's not the size of the study that is the issue; instead, it is the location of the study and the true diagnosis of those involved that concerns me (HALO really needs to reconsider its clinical trial locations). However, when the Phase II studies were halted they, certainly, didn't just look at safety. At that time, they would have considered efficacy as well, and HALO would have halted its study if it was showing to be ineffective. Thus, there is actually a lot of PEG information out there, which could indeed "excite" (or worse, bore) the FDA. It's time we see these data. Good luck!
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