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H2R

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Alias Born 07/17/2014

H2R

Re: None

Wednesday, 08/17/2022 4:39:48 PM

Wednesday, August 17, 2022 4:39:48 PM

Post# of 865
Keeping to September 2022 Resubmission

From the August 2022 presentation:

Compelling pivotal data support
U.S. FDA BLA submission targeted
September 2022



Slide 5, https://ir.outlooktherapeutics.com/static-files/8d2c446a-334a-470b-bbbf-9abbf26d2c31

They've kept the same date for the re-submission, since end of May/beginning of June. Their track record in terms of planned and actual steps provides a certain level of confidence.

On the very same slide, they expect (not plan, since FDA timeline) the following:

Launch anticipated Q4 2023,
if approved



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