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Friday, November 07, 2025 8:42:21 PM
If true why wasn’t that explained in JAMA ten years later? Why did they talk about the trial halt for financial reasons but not the screening halt?
Pretend you’re the CEO and rewrite this for your shareholders based on your version.
>>Since we did not enroll the last 17 of the planned 348 patients, this could adversely affect the statistical and other analyses of our Phase Ill trial results and could make it more difficult to seek product approval or more likely that further trials could be required. There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach.
Pretend you’re the CEO and rewrite this for your shareholders based on your version.
>>Since we did not enroll the last 17 of the planned 348 patients, this could adversely affect the statistical and other analyses of our Phase Ill trial results and could make it more difficult to seek product approval or more likely that further trials could be required. There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach.
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