why don't you read a little before flapping your gums.
as a starting point here's a simple slide show https://www.fda.gov/media/91849/download
Go ahead and correct the FDA , you and the other MSBers love telling us how the FDA is stupid and corrupt and wrong.
re Ralom's comment, Pfeifer's post states there are simpler/faster paths to approval in a jurisdiction than FDA approval. For example, Japan as we know only requires a P2 in this space.
why don't you read a little before flapping your gums.as a...
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