Ann: AGM Presentation 2019, page-5

Well, looks like 12 month dosing for Phase 2b - good result imo.

And....the FDA is now back on the agenda.

NOW THIS IS GOOD NEWS AND EXCITING....shame retailers have to get reamed along the way.

- General acceptance by the agencies on the trial efficacy endpoints (Pul2, Myoset), safety monitoring plan, dosing duration (1 year) and the use of higher doses

- Clarification provided by the agencies that the above could be a path forward to an approval on positive Phase IIb results

- Next step is to follow up development plan with the European Medicines Agency (EMA) and subsequent to the finalisation of the results from the current Phase II trial, engage with the Food and Drug Administration (FDA) on development plans for the US