I agree with you Dontbeanaderhater. We tend to as
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Posted On: 01/23/2021 12:48:06 PM
I agree with you Dontbeanaderhater. We tend to assume everything is a sign of approval. This may not be. But here's my argument:
I would assume that the reason they gave us Open access is because they believe that the potential benefit out weighs the potential risk. Would you agree?
That is the same requirement for EUA. Obviously the data will need to show atleast clinical significance (statistical significance ideally), but I think it's a positive step.
Additionally, from what I've been told, the fda reached out to us and suggested the open access.
I would assume that the reason they gave us Open access is because they believe that the potential benefit out weighs the potential risk. Would you agree?
That is the same requirement for EUA. Obviously the data will need to show atleast clinical significance (statistical significance ideally), but I think it's a positive step.
Additionally, from what I've been told, the fda reached out to us and suggested the open access.
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