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Re: JohnWayne post# 148681

Wednesday, 09/12/2012 11:49:09 AM

Wednesday, September 12, 2012 11:49:09 AM

Post# of 252816
ONCY:

Take the 80 patients from both arms, slice them into two groups, then divine meaning out of the numbers to increase enrollment. If I wasn't of such a sunny disposition all the time, I'd think they're just trying to expand the cohort of months that they receive a paycheck.

Also, can anyone make sense of this?

The Company has consulted with its principal investigators and the independent statistician for the study, and, on September 10, 2012, met with the U.S. Food and Drug Administration in Washington, D.C. Based on these discussions, the Company plans to expand enrollment in the first stage of the study to include 160 patients, all of whom have now been enrolled.



They met with the FDA on Monday to expand enrollment to 160 patients, and by Tuesday they had unwrapped the 80 extra patients that arrived via FedEx overnight?
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