@australiasydney I would say that the piece meant to show US pharma the potential in the US market is the work around market research that RAC has commissioned a third party organisation (presumably a life sciences consulting firm) to conduct.
The current announcement pertains to the regulatory work RAC is doing to help enable the company to chase the US opportunity.
To me it is a 1-2 punch for potential partners or buyers:
1 - here is the massive US potential
2- oh and by the way we've made sure with the FDA that we can smoothly chase the massive potential
Ann: Positive Pre-IND Guidance from FDA on Zantrene, page-13
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