"if an FDA fast track approval is coming"
As I've said before, people really ought to be specific about what they mean when they refer to "FDA fast track approval":
Anyway, here's the reality:
For some reason FDA haven't even released the IND RCHA claim to have applied for way back in October yet. That makes it very overdue indeed.
The drug product can't even be imported into the country, and then there's the small matter of a clinical trial program and the compilation and submission of a full NDA before the product gets approved.
Fast track or not, that will take many years and hundreds of millions of dollars, neither of which RCHA has.
BTW, if you meant to say fast track designation (quite a different thing from approval, of course) then even that is highy unlikely.
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