Canadian Sites What are your thoughts on the 3 Canadian sites (Calgary & Toronto) participating in our AKI Phase 2 trial.
I was looking back on news releases. Calgary site was announced in March 2023 and about 8 weeks ago announced Ethics approval but still waiting for Alberta Health approval. We have been waiting now over 5 months.
The two Ontario sites are even further behind. They were announced shortly after Calgary but we still dont even have Ethics approval let alone provincial approval.
Now all of these approvals are out of the control of Arch.
It is very disappointing how long the final approval takes in Canada, its no wonder many companies avoid Canada but on the flip side it's unfortunate for those who are sick have no opportunity to experimental drugs or treatments that could save their lives.
We have been dosing in Turkey Since March at 5 sites. The question is how many patients have we dosed. We obviously dont want to rush the dosing and select the most suitable patients.
Conservatively speaking I feel 1 patient per week per site. That equates to 5 patients per week, 20 patients per month.
We started dosing in March so 5 months under our belt, so potentially we have dosed 100 patients.
We sure could use an update on the number of patients dosed. I wonder if they have observed a signal. Every day that passes lowers the risk.
Should these 3 Canadian sites finally get final provincial approvals and actually start dosing it should get us to our goal of 260 patients in 2025.
I wonder where the Pontiac trial sits with approvals for sites. It was mentioned fall 2024 commencement of dosing. I assume Arch has no knowledge as they are simply providing the drug.
Based on timelines above I suspect Pontiac may not start to Spring of 2025 but again we have no idea where they are with various approvals.