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Friday, 10/28/2022 9:38:30 AM

Friday, October 28, 2022 9:38:30 AM

Post# of 862
OTLK Today we had 3 very good news from the FDA:
1) Acceptance of the OTLK BLA.
2) The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023.
3) ONS-5010, if approved, is expected to receive 12 years of regulatory exclusivity in the United States.


With all of this and also the Approval of the OTLK accounts for the fiscal year 2022 (as of Sep 30, 2022), the buyout to OTLK should be announced.
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