Hi Southoz
I recall this issue came up some time ago but I don't remember who posted the response. Was it Eagle888?
Anyhow, from memory the answer was that there are different terminologies in the classification of the trial designations under the EU authority as compared to the USFDA. That's all I remember about it, someone else here might have more details.
We poor mortals are hard pressed to navigate the subtleties of one convoluted government authority, let alone two.
Cheers
K
the facts about prr trials, page-14
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