If you just halt upon receipt of the DSMB recommen
Post# of 153874
(Total Views: 597)
Posted On: 10/19/2020 2:01:38 AM
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If you just halt upon receipt of the DSMB recommendation, without careful analysis of your options, and the FDA then says, but....you should have continued it a little longer, you just ruined your clinical trial, and as I said above, must start the entire trial from scratch again!
That isn't the way it works. The trial would start up again exactly where it left off. The data from the 195 patients in the interim cohort would be added to the remaining 195.
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What you certainly are not going to do is immediately actually halt for efficacy and end the clinical trial, or even move all the placebos patients to active drug. Seems you would need FDA approval for that.
The determination of a halt is solely up to the company. The FDA recommends that you discuss it with them before a halt.
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I propose that your PR would be a bland vanilla no frills PR similar to the one that was issued last Thursday evening, scheduling a CC for this week, suggesting there is a regulatory path forward, set for a time that the company can inform the shareholders of not only the recommendations, but what they have actually decided to do with regard to the recommendations.
If the company set a schedule based on any non-statutory FDA timeline they're fools.
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