Ann: Appendix 4E and Full Year Statutory Accounts, page-2

Importantly, the FDA noted that the proposed design of the Phase IIb/III study (as a single, randomized double blind, placebo-controlled study) and the primary endpoint (PUL2.0) appeared acceptable. Secondary endpoints of muscle strength as assessed by MyoGrip, MyoPinch, and predicted forced vital capacity (FVC), also appeared reasonable as was the 52-week study duration, non-ambulant patient population and number of subjects relative to statistical power assumptions. Provided appropriate safety-monitoring recommendations are adopted by the Company, the FDA said it could consider the exploration of higher doses of ATL1102 beyond 25mg/week subject to adequate justification.


The above from the announcement….
Imo: Design of the Tox animal study… and if the European study goes well …That will be enough to lift the partial hold and increase the 25mg per week…and commercialise it in the US $$$$!