I have never thought Diagnostics Phase 3 applications would Qualify for FDA, Fast Track Designation Status, but I think this could be the exception and look forward to getting other opinions.
It meets unmet medical need (there are chronic shortages of current standard care drugs currently used)
It has preliminary clinical evidence that it provides a meaningful improvement in diagnosis (believe the last trial show this)
Saves Lives , early accurate detection saves lives.
Interested in other opinions.
Arthur
I have never thought Diagnostics Phase 3 applications would...
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