Outlook Therapeutics Inc (OTLK): OTLK - Corporate Presentation JUNE 2022...

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pfelgueiras

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Friday, 06/10/2022 10:13:32 AM

Friday, June 10, 2022 10:13:32 AM

OTLK - Corporate Presentation JUNE 2022
New on Slide 05
• Compelling pivotal data support U.S. FDA BLA submission targeted Sept. 2022
• Launch anticipated Q4 2023, if approved.

New on Slide 27
• Sufficient capital to support pre-launch activities for ONS-5010 and a pathway to potentially support launch if approved.

New on Slide 28
• U.S. FDA BLA submission targeted September 2022 with anticipated approval to follow 8-12 months later.
• Sufficient capital for pre-launch activities and potentially through launch.
(in May they said **"**Sufficient capital through the anticipated approval of the ONS-5010 BLA")

OTLK Did not give any explanation why they withdraw the BLA!
They only said they are "Compelling pivotal data support U.S. FDA BLA submission target Sept. 2022"

( See more information about OTLK at r/OTLK_Investors )

SOURCE:
https://ir.outlooktherapeutics.com/static-files/10b909de-a80a-45af-a98d-470ce9f068ef