ASX Announcement 30 July 2020
European Medicines Agency DMD Scientific Advice and Regulatory Process Update
• EMA feedback reflects the prior scientific advice from the three EU national authorities on appropriateness of key trial design parameters
• Inclusion of 25mg dosing arm into the study given demonstrated efficacy in Phase II
• Company to define clinical and regulatory pathway in the US as a priority
So over 2 years ago we planned and prepared for the pidco and a way to market now the pidco is on hold
Has anyone even thought that this plan Ph2b we are now embarking upon, could have well been carried out in tandem alongside the application for the pip
talk about time wasted
We could have had this 2b completed by now 2 years on with extra data and placebo if that is the case, and we back pedal for the cheap route yet again, because these people are incapable of raising the funds to carry us forwards, yet i say again the likes of Pepgen raise $150 mil with no data whatsoever
I would not be surprised at all if Platinum are leaving the building the way this is playing out
Its a disgrace
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Ann: ATL1102 Revised Plans accelerate reporting of unblinded data, page-79
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