Hmm, I don't think there would be any dependacy on the FDA since it's a separate duristiction. PAR could have just gone after Europe (EMA) and Australia (TGA) without any FDA involvement at all, but obviously the US is a giant market and the decision was made to harmonize trials across all 3.
Where we at?, page-549
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23.5¢ |
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| PAR (ASX) Chart |