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Posted On: 11/04/2024 5:59:15 PM
Post# of 148866
Quote:
Typically, how long are these trials? weeks, months, years?
I would expect mssCRC phase 1 and phase 2 to be 1 year long. Sufficiently long enough to hit statistical significance. Alzheimer's phase 2 also 1 year but conditional approval is possible on a phase 2 for that disease so a phase 3 would be unnecessary.
Quote:
I know you believe that LL will be very effective, is there any way that it is so successful that the trial is stopped as it is so evident who is getting LL vs placebo/SOC
Even if it was evident the trials would be run to completion to satisfy the FDA. A mid-trial analysis might be done if specified in the trial protocol but this would be used by the Data Safety Monitoring Committee to look at safety and possible modification of the trial protocol.
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