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SX Announcement14 March 2023 Dosing commenced in the ATL1102 toxicology studyAntisense Therapeutics Limited [ASX:ANP | US OTC:ATHJY | FSE:AWY]

(ANP or Company) today announced the commencement of dosing in the nine-month chronic monkey toxicology study of ATL1102. Dosing of all animals will be completed in November this year with study outcomes on track for reporting in 1H’24 as previously advised1. The toxicology study is intended to support the advancement of the ATL1102 program in the US for Duchenne muscular dystrophy (DMD) or any other clinical application of ATL1102.Successful completion of the toxicology study is expected to be the final requisite step for the FDA to allow dosing of ATL1102 for a term longer than six months in the US. Successful completion of the study should also allow ANP to apply for expedited program status with the US Food and Drug Administration (FDA) including Fast Track or potential Breakthrough Therapy designation. US FDA has already granted ATL1102 an Orphan Drug Designation and a Rare Pediatric Disease Designation for the treatment of DMD.The reporting of key study findings from the nine-month chronic monkey toxicology study in 1H’24 is due around the same time as the results from the blinded phase of the ATL1102 Phase IIb DMD clinical study are expected, which could then allow the Company to share with FDA and other regulatory bodies a compelling data package of clinical and toxicology study results for potential discussions on accelerated regulatory pathways to registration. In addition, and subject to it meeting the eligibility criteria, the Company may also be in a position to receive a future Pediatric Review Voucher (PRV)2,3. In recent years the price paid for PRVs has ranged between US$95 million and US$110 million4.This announcement has been authorised for release by the Board.1 QuarterlyActivitiesReport-25January2023;2 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/rare-pediatric-disease-priority-review-vouchers 3 https://www.asx.com.au/asxpdf/20200930/pdf/44n4zn057xt9fx.pdf4 https://www.kidsvcancer.org/priority-review-vouchers/

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So we have complete 6 months and 1 day of Tox study
Looking good . no