The ducks all appear to be lining up. There is the harmonisation of EU and US development plans. There is the PIP addressing the entire paediatric development program that potentially includes both ambulant and non-ambulant studies. Just to extend the metaphor, the PDCO feedback is in line with expectations and the US FDA feedback is highly supportive and even collaborative. There remains just one little duck that is waddling around that needs to be brought into alignment.
Will it be the go-it-alone duck, the licencing duck or the hybrid market jurisdictional duck. Some might even think it could be Scrooge McDuck with the really big purse. Whatever is finally revealed, the opportunity in ANP is far greater than its current market capitalisation. The first twenty years went slowly, the last 12-24 months have been incredibly exciting but the next 6 months could be transformative.
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- Ann: ATL1102 for DMD EMA PIP feedback and FDA regulatory progress
Ann: ATL1102 for DMD EMA PIP feedback and FDA regulatory progress, page-47
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