Ann: Notices received under s203D and s249D of Corporations Act, page-25

Did the drug fail - or did PER management fail the drug?

PER has form in manufacture cock-ups. This might well be another one.

Hard to reconcile the Proteomics blood analysis from P2A with the recent failed P2B results.

Using the Proteomics data analysis - PER explained to the whole DMD community the reasons why fat fraction % was lower in boys that participated in P2A trial, at 25Mg dose?

How on earth can MRI scans show lower fat fraction % after 6 months on ATL1102? With PUL scores materially superior to natural history?...and now during P2B, we have zero efficacy?

The ATL1102 drug was manufactured in mid 2021...but most boys were injected in 2024.

More to this story - it seems Bob Moses thinks so too.

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26 May 2021
Manufacture of ATL1102 clinical supplies for Phase IIb trial in DMD
• Manufacture of ATL1102 active pharmaceutical ingredient (API) batch completed
• Formulation into injectable product for use in the Phase IIb trial completed
• Drug Product testing underway for release for use in clinical trials

"Upon completion of the manufacture of this batch of API by Avecia last month, the material was then shipped to Contract, Parenteral (injectable) Drug Product Manufacturer Pyramid Laboratories in Costa Messa, Southern California and formulated into injectable product for use in the Phase IIb trial. This formulated injectable product (Drug Product or DP) is currently undergoing finished product release testing for clinical use, with results anticipated later next month."