New amendment posted 10/17 adding 6 new study sites:
2 in Canada
3 in Chile
1 in Spain
Now multinational adding to 6 in Australia. All 12 are recruiting.
Still none in US I suspect the additional 100 participants added to the P2 trial in May '23 has not yet been filled. Gotta fill additional P2 before recruiting for P3. Only US sites in P2 restarted recruiting.
It's progress toward a point at which FDA believes P3 is sufficiently underway to accept an application for accelerated approval.