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Re: flipper44 post# 64073

Thursday, 06/09/2016 10:52:47 PM

Thursday, June 09, 2016 10:52:47 PM

Post# of 699268
flipper44,

Great find. The words "positive or negative selection" sums it up for me. Now from this you can determine the approximate time for final manufacturing approvals to be granted based on time needed for final acceptance of the translated patent documents (if the Germans require this), the commercial manufacturing site inspections being passed (where any new sites or expansion has occurred) and verification that final staffing needed has been put in place. Contract manufacturing appears to be in place for early initial demand. Sawston is prepped for rapid buildup of additional multi product capacity and just needs to pass inspections to have manufacturing approvals granted which would also correlate to the second part of the PIM application.

The trial is still scheduled to end in September/October even if many lives that otherwise would have done likewise, according to Dr. Linda Liau, do not. Best wishes.
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