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Post by mikesmilitaria on Aug 30, 2017 12:48:45 GMT -5
Hey pal----I'm still here and believe within the next few weeks we will finally be seeing some reward for our patience. The LABEL is the key as it opens so many valuable doors. Will the FDA bring home an approval before 9/28? I just hope they bring home an APPROVAL! I don't see how the label could be rejected but since I'm invested here it is possible. Hang tight pal---see you at the bank.
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Post by mnholdem on Aug 30, 2017 13:34:27 GMT -5
Check out the FDA approvals during the past 14 days:
www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.page
Busy, busy, busy... and note that the vast majority of approvals are under the Submission Classification: Labeling.
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I'm not sure that the FDA would be able to give MannKind an exact date but as I understand PDUFA guidelines, the sNDA for Afrezza will be decided before the last day of September 2017.
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Post by orlon on Aug 30, 2017 14:03:29 GMT -5
This is worth a reply....check mannkind website, look at investors, check historical data et voila....glad to be of service. Let me think though, someone else who never checks facts and calls it fake news. Just can't recall the name. Any Idea?
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