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Re: growingpain post# 443392

Wednesday, 12/20/2023 1:37:38 PM

Wednesday, December 20, 2023 1:37:38 PM

Post# of 462919
This analysis is not a basis of approval — so doesn’t need to be pre-specified. However, this analysis may support the reasoning behind the mechanism of action — and may inform their future trials and/or indications to pursue. In that context, it may be useful. It may also form supportive evidence for approval, if the primary evidence is reasonably solid.
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