So I'm not saying they didn't get advice for the upcoming trial. We don't know anything about the design or the control groups so for all we know they're doing exactly what I think they should!
They explicitly said the FDA agreed to the endpoints, which means they consulted them about that. Hopefully they got more guidance than that.
We'll see when they give us more details.
People are making a ton of false assumptions and putting unnecessary spin on my statements.
All I want to say is I hope MSB does this trial carefully and correctly, and meet their primary endpoints.
If the cells work, it shouldn't be hard to prove
Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain, page-164
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