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Alias Born 09/27/2016

Re: trickledownfacists post# 8746

Tuesday, 09/27/2016 12:33:48 AM

Tuesday, September 27, 2016 12:33:48 AM

Post# of 43716
Just speculation on my part, but maybe has to do with getting FDA approval for the enrollment changes for the P3. In their 8K, they don't seem to say whether or not the FDA has signed off on the changes, unless I just missed it.

From their 8K:

"The regulatory bodies of several countries have already cleared the changes for the study. The review process in other countries remains ongoing. The full implementation of these changes will not be possible unless the regulators in the countries with the top patient enrollment agree to the changes."
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