For re inspections the FDA has a Final 60 day rule . FDA will determine if the facility cleared inspection at least 30-60 days before the PDUFA date ...June 29th . So we are near the end of that window ......deadline May 29th . FDA on site inspectors will notify plant immediately of their decision and then follow up with a notification to UNCY thru FDA formal channels If there are issues still to be resolved FDA will issue Form 483 ...listing the issues .
If no Form 483 is issued its a very positive sign for UNCY that they will receive a clean notice . So we should know within the next 18 days.
Above just my understanding of how this works
The Co in India is supposed to know immediately following the inspection . If theres a problem UNCY will probably wait until they receive the formal Form 483 ...and then can even wait 4 business days to disclose I think . However this info is often leaked ...so watch the stock direction and trading volume over next week or so . FDA will normally want 3-4 wks to finalize the labeling ...and what UNCY can include on the label ...so re inspection decision is imminent JMO Kiwi
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