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Posted On: 01/23/2022 10:17:27 AM
Post# of 152583
I am pretty sure that the FDA has definitions of "substantial" and "relevant" in connection with issuing BTD so that they are not vague.
If I recall correctly our improvement was NOT substantial over the current SOC which changed in the middle of our submission.
If I recall correctly our improvement was NOT substantial over the current SOC which changed in the middle of our submission.
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