As the approval process is currently focussed on things like packaging, clinical outcomes assessments, branding etc, I find it hard to imagine it'd be rejected before September 8th if it was going to be rejected. Any issue they identify at this point would more likely be the FDA saying "no you can't claim that, fix it" and BOT going away and doing so, imo.
Though I interpret "clinical outcomes assessments" to mean what you can and can't claim from the studies, not whether the drug is safe or has worthwhile efficacy, which are the things that I could see causing sudden rejection.
As the approval process is currently focussed on things like...
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