So what are the Next Steps included in the announcement re: discussion of emerging results and determination of optimal path to registration. The emerging results will presumably arise out of the topline data at 6 months due in December 2024. The optimal path to registration will be an FDA accelerated approval particularly given that on the 27 May we were advised of the all important preliminary results of the 9 month toxicology study.
In the background is the buzz around the commercial path forward in funding the confirmatory trial and eventually marketing ATL1102 aka avicursen. The window is clearly in the frame for 2024. There is undoubtedly a front runner so its just when do they step up to the plate.
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