Phase 3 Fast Track Approval?????Yes Yes I know that they have not announced it yet and I may be getting ahead of myself but please bare with me.
1. First management was focusing on the largest market $20 billion worldwide which is for Kidneys -Acute Kidney Injury. Makes sense right?
2. Then they pivoted to Lungs, a lot smaller market estimated at $1 billion. Why did they do that?
3. COVID hit around March 2020, because of this they saw a faster path for approval thru the Lungs than Kidneys.
4. By getting fast track approval it is of a higher priority for the regulators to clear the Governmental Red Tape that it takes to get thru.
5. I believe that the Canadian Govt will Fund P3 as they did for P2 but in a much bigger way. Because they defineltly want to have a Canadian Company that is part of the WHO Protocol for COVID. (Arch is their Pathway)
6. This does not mean that they have forgotten about the Kidney market, I am not an expert on the drug approval process in Canada, but if is like the FDA in the US. I think they can dual track it somehow.
7. I am told that for they will know if it is working in P3 it takes a couple of weeks to see how it is working to reduce inflatmation in the lungs.
8. Let's say it is working then they can do an emergency review for approval
9. I am not sure how long this will take but I know if it is working they will not wait the normal 2 years for P3 approval. My guestimate once P3 starts and they start the drug transfusion therapy. It will be from 6months to a year.
10. Don't Forget once this is all taking place and stock price is a lot higher then i believe they will do a capital raise for the funding for P3 for Kidneys that is when the Institutional Investors will be participating and we will get analyst coverage with Buy Recs.
11. Big Pharma will be lining up to buyot ARCH or take a stake in us.