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Re: Rkmatters post# 24938

Tuesday, 11/25/2014 4:30:16 PM

Tuesday, November 25, 2014 4:30:16 PM

Post# of 700282

I missed it. I read quickly. What do you want to bet? --- RKMatters


I found his bet, for a cream soda, buried in post 24925:

It may well be connected to the trial changes. We still have not heard that the final negotiations with the PEI have been completed. That could well be what's holding things up. In fact, I'd wager a cream soda on it ;) ---DrChuck



See PR dated 8/11/2014, which includes:

The Company has obtained approval from the US FDA and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and conditional approval from the German regulatory authority (the Paul Ehrlich Institute, or PEI). The Company is now working toward the final approval from the PEI.
The trial enhancements will also have to go through Institutional Review Board (IRB) review and approval at each of the clinical trial sites.
There are currently over 50 trial sites in operation in the US and a number of sites in operation in the UK and Germany.
There will also be certain other requirements for implementation of the changes, modified documentation and procedures. --- from the PR


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