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H2R

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H2R

Re: INV4 post# 750

Thursday, 11/02/2023 8:28:42 AM

Thursday, November 02, 2023 8:28:42 AM

Post# of 1088
Thanks INV4,

That's the type of information we are all waiting on. It's hard to believe an actual trial is required, and that the new trial would be this "fast"

a clinical trial design that would most likely allow for the resubmission of the ONS-5010 BLA as early as the end of calendar year 2024, and subsequent approval around mid-2025, pending final agreement on a clinical trial protocol with the FDA and successful completion of the required additional clinical trial.



OTLK will need to design the trial, fund it, enroll it, complete it, etc. All that in one year. When it's on clinicaltrials.gov, it will give us a more concrete sense of the trial design and some of the relevant details.

Thanks again.

Best of luck with your investments!
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