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Whalatane

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Whalatane

Re: rosemountbomber post# 2029

Saturday, 11/08/2025 2:24:43 PM

Saturday, November 08, 2025 2:24:43 PM

Post# of 2864
Key will be the PDUFA data the FDA gives them , once they accept the resubmission .
If the resubmission is a Class 2 resubmission ...which we expect ...so 6 mths .
UNCY needs to disclose details within 2 wks of FDA decision .
The real wild card and low probability is a Class 1 re submission ( 2 mths ) as re inspection of manufacturing facility is expected ( Class 2 )
JMO
Kiwi
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