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PG

Re: Teddyk46 post# 83975

Tuesday, 07/09/2013 9:03:20 PM

Tuesday, July 09, 2013 9:03:20 PM

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You are missing the point--they heard back from the FDA within 30 days. The FDA requires additional information. Therefore, nothing starts until the Q&A is complete.

BMSN does not qualify, with this application, as a categorical exclusion.




Sometimes, you just have to walk away, let the dust settle and look at it all from a different perspective.

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