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Re: john1045 post# 6122

Thursday, 03/13/2014 9:31:01 PM

Thursday, March 13, 2014 9:31:01 PM

Post# of 709060
Just thinking about this from a double-blind randomized trial framework, examination by certain entities does not remove the blind, nor does it endanger the trial as long as the 3rd party examination is carefully planned and executed.

It also reminded me that Linda Powers recently stated it will take about a year to get to market from the point the trial is unblinded (if memory serves).

So access and reimbursement in Germany will help save many lives while the EMA and FDA are sorting through matters -- during said one year window. The revenue from Germany will also help finance the NDA effort -- as you already know.

Very smart.

(Nice catch John)
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