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Re: Hoskuld post# 509981

Wednesday, 11/26/2025 11:32:16 AM

Wednesday, November 26, 2025 11:32:16 AM

Post# of 519108

running another 500-750 patient confirmatory trial seems like it should have been a no-brainer...so, again, the regulator asks itself: why wasn't one run?


Answer: Cost and time lag to market. AVXL isnt J&J. Plus thousand of additional lives would be lost in the years this would take.

Better answer: if a confirmatory trial is so vital, grant conditional approval and we will have money to fund a 2000 patient confirmation trial. In the meantime, numerous lives would be saved that otherwise would be too far gone for 273 to help. So ask the regulator, why not this conditional approval?

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