Sunday, October 02, 2022 3:27:51 PM
Nobody is arguing against your point.
Again, it's all about the claims. If we do not make any new claims, then I'm with you 100%
If we claim that Extra works better than the previously cleared product, we
'll need proof in the form of clinical evidence right?
If we claim a new benefit, e.g. enhanced healing, then we'll need proof for that as well.
These are presumably the questions that BIEL wants to discus with the agency, and the point of filing the Q document.
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