Ann: Safety Review Committee Approves Second Cohort, page-22

From the Report and obviously AGN are a bit behind so far with Phase 1:

The company has not provided much detail on potential Phase 2 design,
as the structure is likely to be guided based on Phase 1 trial results. We
would expect AGN to begin planning immediately following successful
preliminary results. Indicatively we would expect:
12 to 18 month trial;
50-75 patients;
Multicentre (Australia); and
Admitted to metro-based patients in the emergency department.
The last part will be especially important, as timing of intervention
is likely to greatly affect efficacy outcomes as shown in preclinical
research. Optimally, the study would be designed so that ARG-007
is administered as close as possible to the stroke event. AGN looks
to manage this risk by administering ARG-007 in the emergency
department.
However, it should be noted that such a design will come with a
significantly more complex work-flow, and hence risks. The difficulty
would come from operating a clinical trial in what’s normally a chaotic
emergency setting.
This study does not require an FDA IND unless AGN plans on running
US clinical sites.
Timing will depend on results of the phase 1 trial, however, indicatively
we would anticipate ethics submission required to kick-off the Phase 2
trial around Q1 CY23.
We estimate the Phase 2 to cost approximately $10m depending on the
number of sites and patients required.