Joe, I thought I might open a different thread mate because it might generate some discussion...
EMA is the combination of 28 Euro countries plus another 7 appointees for co-ordination whereas the
the FDA is solely North American.....
AIPAC is trialling in Europe, not in 28 countries but approx a third of them, any of those countries
can approve Aipac.....If you remember back a couple of years ago the then Prima Biomed appointed
Dr Christian Meuller, based in Germany as Manager Clinical trials...Meuller has brought previous
trials "home" so to speak....With the EMA setup you can see why someone of his ilk was needed....
AIPAC is a Randomised Clinical Trial (RCT) and as such if the EMA approve it for commercialization
the data can be submitted to the FDA for similiar consideration without the need for a RCT....
Co-operation between EMA and FDA is quite robust these days, so we can see the importance
of Dr Meuller....The FDA is quite receptive for trials of unmet needs as Aipac is....
Bear in mind people, I'm in the construction sector not medical....
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