"• Currently, there is still a “hard stop” at the six-month mark after a certain number of patients have been enrolled in the trial. This may change to when 50% of the patients have been treated. This will be part of the new trial design and won’t be finalized until the entire study synopsis has been revised to reflect what occurred at the pre-IND meeting."
Isn't still having to determine the number of patients that need to be enrolled in the trial a big deal? The entire study synopsis needs to be revised.
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