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Thursday, October 01, 2020 10:30:36 AM
"ANECTDOTES DONT COME OFF LIFE SUPPORT"
The drug works. People are getting so wrapped up in interim results.
RESULTS ARE STILL COMING - Folks that sold on not taking a hit to the P=value.
Whether we took the hit to the p=value or not we still get an announcement in 2-3 weeks on the interim report. The DSMB will say one of three things
1. Stop the trial you are unsafe
2. You are doing good but you need to add more patients to get statistical significance
3. You are on target continue the trial it looks like you will hit your endpoint.
So we should ALL be expecting number 3. If we get #3 then the company will plead with the FDA and say we are likely to hit our endpoint thats what you told us so why not just approve us - we are in pandemic times.
What many seem to be rightfully concerned about is that this argument wont work with the FDA. It might not but then what? we finish the trial we meet the endpoint we ask for approval.
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