The FDA works on US time. New York is 15 hours behind. That means the decision will not be known until the wee hours of Wednesday the 9th AEDT.
If CUV immediately release the decision then we will see it released ahead of ASX open on Wednesday but it may take sometime to digest requiring a trading halt.
If the USA is prepared to support the "ophan" treatment it will double sales. If not sales will remain as is.
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Ann: FDA Clarifies SCENESSE PDUFA Date, page-22
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