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Wednesday, 12/28/2016 3:42:46 PM

Wednesday, December 28, 2016 3:42:46 PM

Post# of 430174
Interesting tidbit - I was doing some required training that covered good clinical practice standards. Turns out there have been efforts to standardize clinical trial requirements across the US, Europe, and Japan (International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use). Compliance with these standards for purposes of FDA approval is not required, but is strongly encouraged. Assuming AMRN complied with these recommended standards, they would be able to submit the same R-It data they submit for FDA approval to the Eurpoean market for approval there as well without having to do additional trials. Anyone have any idea whether R-It might comply with these standards? Opens up some easy ways to increase their market if so (unless their patents do not cover Europe).
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