Ann: Shareholder Newsletter, page-65

Thanks @samfiodiving,
From 17 May 2023 I asked the question could it be argued that Sarepta is creating a template for ANP to follow as well as a precedent for accelerated approval? I was on the right track but it appears that the relevant precedent for accelerated approval was set, as described by the MD in the Shareholder Newsletter, in the rare neuromuscular disease space. Presumably the MD is referencing the recent accelerated approval of Biogen's drug tofersen that treats a rare and aggressive form of amyotrophic lateral sclerosis (ALS) also known as Lou Gehrig's disease. Three points should be made immediately;

1. Accelerated approval was granted in April 2023
2. Tofersen is an antisense oligonucleotide
3. Biogen licensed tofersen from Ionis Pharmaceuticals

The ink for the precedent is barely dry, accelerated approval was given to an ASO and one can readily deduct the last defining similarity between tofersen and ATL1102. I am positive there is much more to learn about the relevancy of the journey of tofersen to accelerated approval and will later attempt a deeper dive.