My understanding is that FDA approval is needed for the US, however given that nothing exists already in this space and exhaustive testing already conducted, it should go smoothly.
Genelabs have exclusivity I think for all areas outside the US. So, theoretically, Select could do another Hep E deal in the US. What is more likely is that they will work with Genelabs in the US as well since Genelabs have been bought out by a US diagnostic ompany.
It boils down to: which company is likely to be most successful.
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