Ann: ANP Updates on US Regulatory Plans for ATL1102 in DMD, page-49

So the company says in their summary:

- Revised clinical trial protocol to be submitted to support lifting of the partial clinical hold
- Fast Track Designation request to be resubmitted once partial hold is lifted

1. The only way to "revise" the clinical trial protocol & lift hold is to go back to a 25mg dose which FDA is happy with?

2. The partial hold only refers to dosing regime greater than 25mg.

3. Fast Track Designation can then be resubmitted if plan includes dosing at only 25mg.


Maybe the higher dose arm is in the EMA trial first?

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