Where others have failed will Atl1102 succeed ?, page-406

ASX Announcement22 June 2021

Feedback received from EMA Paediatric Development Committee (PDCO) on PIP PDCO feedback in line with expectations FDA Fast Track Designation Request submitted To the extent possible, Company is taking the opportunity to harmonize EU and US developmentplansAntisense Therapeutics Limited [ASX:ANP | US OTC:ATHJY | FSE:AWY], (the Company) today announced that it had received feedback on the Paediatric Investigation Plan (PIP) for the development of ATL1102 for Duchenne muscular dystrophy (DMD) from the Paediatric Committee (PDCO) of the European Medicines Agency (EMA). As part of its review of the PIP, PDCO provided feedback outlining additional information requirements on the Company’s planned Phase IIb clinical trial in non-ambulant DMD boys. Overall, the feedback on the Phase IIb trial is in line with Company’s expectations with the key features of the study protocol remaining as noted in the Company’s PIP submission announcement of 25 February 2021.As an interim step, prior to submission of the Phase IIb clinical trial application, ANP is now preparing responses to the PDCO information requirements. The Company anticipates finalising the trial design with PDCO later in Q3’CY21 ahead of submitting the clinical trial application for the Phase IIb trial of ATL1102 in non-ambulant DMD patients to be conducted in Europe shortly thereafter.A paediatric investigation plan is a development plan aimed at ensuring that the necessary data is obtained through studies in children. Approval of the PIP is required to support the authorisation of a medicine for children in the European Union (EU). The PIP addresses the entire paediatric development program for ATL1102 in DMD (including potential ambulant DMD patient studies). ANP through its interactions with PDCO, is looking to ensure that its planned clinical studies will be run in accordance with PDCO expectations for future product approval.Nuket Desem, Director, Clinical and Regulatory Affairs at Antisense Therapeutics said: “The EMA’s PDCO feedback via the PIP Summary Report was constructive. We have appreciated the collaborative approach of the EMA to assist us in refining the study design for the proposed Phase IIb clinical trial in Europe. It’s another important step towards bringing this new therapy to patients in the EU.”In parallel the Company continues to progress its interactions with the US Food and Drug Administration (FDA) and has recently submitted a FastTrack Designation Request (https://tinyurl.com/fwhemd95). Given the outcomes reported following ANP’s recent Type C meeting with the FDA and the FDA’s positive feedback on the design parameters for a US Phase IIb/III study, the Company continues to work with its expert US based regulatory advisors on appropriate next steps to advance the ATL1102 DMD program in the US.While the Company’s Phase IIb clinical trial protocol was initially developed to meet EMA’s expectations, the recent feedback from the FDA has provided the Company the opportunity to streamline the regulatory processes in Europe and the US and to the extent possible harmonize the Company’s overall global clinical development plans.This announcement has been authorised for release by the Board ATL1102 for DMD EMA PIP feedback and FDA regulatory progress For more information please contact: Antisense TherapeuticsMark DiamondManaging Director+61 (0)3 9827 8999www.antisense.com.auLEVEL 1, 14 WALLACE AVENUE, TOORAK VIC 3142
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Correct.
Anp already knew that PEDCO would want further info .. Knowing Anp : George and Mark would have replied straight away….

So the announcement came out on the 22 June 2031

let’s say the reply would have gone out before months end….

Announcement said shortly after it would be submitted to EAP…

So they would have submitted it prior to mid July… In that time EAP met 3 times ( mid month)

So from deduction Anp already have the green light…