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Re: Steady_T post# 741090

Tuesday, 12/31/2024 7:30:14 AM

Tuesday, December 31, 2024 7:30:14 AM

Post# of 818590

First there is no such thing as FOIA request to a company.



That's not what I said. The company absolutely has the ability to limit FOIA request information as this POS has.

From the protocol:

One of the two planned interim efficacy analysis was conducted in March 2015 after 56.4% of subjects had completed 6 months follow up.



Now go submit an FDA FOIA request regarding FDA halt of the trial after March 2015 IA. You will get a call from the FDA indicating that the company does not wish to disclose the information. You can ask the FDA rep if this is a material event and they will confirm it is not.

You should look up the definition of "recommendation" since English is apparently your second language.

Also from the original protocol:

Based on its findings at either regularly scheduled or emergency meetings, the DMC may recommend continuing, stopping, or altering the trial. At its regular meetings, the DMC will review data on recruitment and on both safety and efficacy endpoints. The DMC will see data separated by treatment group. Possible reasons for a recommendation by the DMC to stop the trial are an unacceptable excess of AE among patients treated with DCVax-Brain, an excess of
primary endpoint events in the treatment cohort, low power to show a beneficial effect of DCVax-Brain, and insufficient enrollment into the study
.



We know it's not a excess AE issue. DCVax is as safe (and efficacious) as placebo. We know it's not insufficient enrollment as they already expanded the trial.

That leaves an excess of primary endpoint events in the treatment cohort, low power to show a beneficial effect of DCVax-Brain. And obviously it wasn't stopped because it works so well.
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