It is worth reading the FDA's guidance: 'Multiple Endpoints in Clinical TrialsGuidance for Industry'.
I am unable to post link but you should find it with a quick google.
The key takeaway for me was line 405: "Positive results on the secondary endpoints can be interpreted only if there is first a demonstration of a treatment effect on the primary endpoint family."
Unfortunately i believe that due to this, it is unlikely that we will be able to get an approval based off the current trial design. Although, the results do look good, so i think there should be an opportunity for a partnership and/or an accelerated approval pathway to assist with the approval overall.
As always, DYOR.
It is worth reading the FDA's guidance: 'Multiple Endpoints in...
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