FDA approval is a given since the clinical trial use the 5 manual APS assessments which are the same as Painchek except for the facial assessment so will be worth a trade but they will encounter the same commercial limitation. The only concern is whether PCK has trained the RCA nurse in the US to correctly perform these manual APS assessments required for both process, if not then there will be a chance were both process of the subjective manual assessments will be inconsistent.
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