Yes, That is my understanding. The CRL the FDA needed to bring up everything they had issues with, and it was only the insert and wording on the box.
Therefore after discussing with the FDA what they wanted changed, unless something material has arisen which it doesn't look like it has and is still safe, no other issues should be able to be brought up.
Disappointing 9 month delay, but we are nearly there.
Yes, That is my understanding. The CRL the FDA needed to bring...
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