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Re: Mingusahum post# 6568

Tuesday, 03/18/2014 4:29:14 PM

Tuesday, March 18, 2014 4:29:14 PM

Post# of 704242
Do you know how many times the FDA and EMA go separate ways on drug approval? The German decision is just that, a German decision! It cannot tell the DMC nor NWBO what they need to know for their own decision they will be faced with making.

The FDA specifically provides a means for the transfer of interim data to occur for licensing applications while a trial is still going on.

The Germans made their decision based upon all clinical trial data to date.

IMHO, I think it is more likely than not that Germany legitimately examined phase III efficacy data to arrive at their hospital exemption and reimbursement decisions. Now they have enough information to negotiate price.

Are you dubious? Yes.


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