Here are some times ANP have reported in their AGM presentation (Dec 21):
1. EU approval - ANP will conduct a multi‐centre, randomised, double‐blind placebo‐controlled Phase IIb/III study of ATL1102 in nonambulantpatients dosed with ATL1102 for 12 months at two dose levels as a potentially pivotal (approvable) trial with afollow‐on open label extension phase.
Start mid-2022.
Marketing approval (if all goes well) - end of 2025
2. US approval - Protocol synopsis submitted to the FDA for a nine‐month chronic monkey toxicology study to support the dosing of patients withATL1102 beyond six months in US for DMD or any other clinical application of ATL1102 ‐ expecting feedback in 1Q’22.
Should the Phase IIb/III pivotal trial in Europe be successful, ANP believes it could be in a position to receive a rare pediatric diseasepriority review voucher (PRV) if it obtains FDA approval for ATL1102 in the DMD indication (as the drug’s first approval) beforeSeptember 30, 2026. The Company may choose to sell its PRV. From 2017 ‐ 2021, sales of PRVs ranged between US$80 ‐ $150million.
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