The FDA decision as to how they will evaluate us regrading blood thinner removal is material news no? I only ask because it has been so long since the breakthrough designation. It seems crazy to take the step of giving us that designation and then putting the decision on their evaluation method on the back burner. What am I missing? If we don't need a trial, they should be close to a final decision. If we do, things haven't even begun. Huge difference. I know some here e-mail them. Can we get clarification? They never answer me LOL.
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