The announcement says 'the Agency accepted Paradigm's responses to five of the six questions received. The FDA response requires further clarification on one remaining question."
Is 'accepting the response' the same as approving the responses? Is it possible when they have 'accepted all responses' they could then give their reasons as to why they're not going to give their approval?
I don't know the process well enough to know if I'm being too pessimistic (or pedantic) here, if anyone could clarify with certainty that would be helpful.
I can't make the webinar, but if this question isn't resolved by then it might be helpful if someone could ask.
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- Ann: PARADIGM REPORTS IND APPLICATION UPDATE
Ann: PARADIGM REPORTS IND APPLICATION UPDATE, page-76
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