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Friday, January 25, 2019 2:43:40 PM
Just so we have an understanding, BIEL received a CRL in November from the FDA. BIEL is now responding to the CRL. In respect to actions in the response, this response goes through a completely different FDA department. Actually in most cases it does. Trusting that the FDA accepts the response from BIEL, clearance may happen sooner then most think.
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