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Re: biosectinvestor post# 438487

Wednesday, 01/26/2022 7:50:48 AM

Wednesday, January 26, 2022 7:50:48 AM

Post# of 701556
Since we didn’t see a delay in the randomization and treatment of those last 32 patients, then no changes to the patient consents could have been implemented because to draft them, push changes through IRBs and call all patients back in for signature and consent takes quite a bit of time. Even if they rushed every single step through, we would have seen a fairly long skip in time, but we did not.

Therefore, no change in consent, no change in IRB status, no change in IB, and that means no change in the known safety profile which includes lack of efficacy.
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