Who says the FDA is the gold standard? The FDA! Everybody has been complaining about the FDA and what they’re approving and not approving and a time frame that makes sense. The Biogen approval and the subsequent other approvals to move forward have been ridiculous. While we have a product that has been out there for the better part of the last five years in human trials with outstanding success so far we can’t get the FDA to move that quick. I say focus on Australian approval then go to Europe and Canada and F the FDA. Once it’s out there the FDA will come around. If the FDA is so good why is our healthcare system so screwed up.
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