If this was "miscommunicated" and only picked up till now and made aware to CUV by FDA that the date is now the 8th, means that we will likely get an answer ln that date. Either an approval or rejection or maybe another delay or some sort.
You would think after this announcement that releasing this draft guidance 3 days prior to the orginal date 6th and then reject it on the 8th makes no sense.
Ann: FDA Clarifies SCENESSE PDUFA Date, page-3
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