Thursday, August 25, 2016 2:48:37 PM
And as has been point out by me this is a NEW entry as of Apr 06th on a NHS affiliated website. The 3-4 years you refer to is information from the US. Your remarks about 'fast track' also are irrelevant. This is because these comments are made from the UK. Fast track is a terminology that would be used, accelerated approval is an official terminology from the FDA. Again this does not 'hold water' as the comments were made April 2016 in the UK and not at the start of the trial.
The site you are talking about is noting items of interest. The ones in question are from the SEC form 10-K. That is clearly stated. The comments are not "from the UK", they say nothing about what is going on in the UK. And the date is simply when they were posted.
And approval over their is via the EU EMA, not NHS (though NHS would later sign off on insurance coverage once they get the EMA MMA).
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