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marzan

07/25/19 10:22 PM

#203852 RE: Jamaalish #203843

Jamaal, I wouldn't be surprised if we get the sNDA approval before the quarterly call next Wednesday premarket. Note the sNDA final review meeting should take place by 7/28 meaning either tomorrow or latest by Monday. The signatory designee must be present in this meeting. If everything is ok including the $400M raise that guarantees ability to meet the demand, pretty much the expanded label will be signed off that day, imo. With all these blessings from ADA, AHA, ICER overwhelmingly, I see a fast approval shortly.