Post by
general360 on Apr 12, 2021 10:34am
animal/lab work, $, Canada gov't?
so, last we heard, immediately we were going to file this and get crack-a-lackin. 2 months later, we're cleared for an open label P2?? from canada only at this point. what changed? were we able to get past the animal study part? what about the big funding from Canadian govt?
from the transcript:
"We can finance this internally, and we also have applications out to government bodies. We have received approval for a large funding from the Canadian government. However, they don’t quite understand the system here. They want to start with us going backwards and doing animal studies. So I think we’ll pass on that one."
so, animal studies dont matter any longer? we dont have to do them if Health Canada is allowing us to proceed? what about the money? does this go hand in hand w/ trial registration?
looks like it all still boils down to clinicaltrials.gov registration for the full protocol. still waiting on registration for that one. so we dont start w/ out starting in the US? no mention of funding from US gov't so not waiting on them, just the Canadian govt, the Alberta gov't (we're collaborating, whippee!), and of course those fine people the sheihk. still no mention of where money is coming from, other than this is cheap... To me this sounds like gravy, having Canada on board. this was always supposed to be US based trial. Again, from the transcript (bolding mine)
"We’re filing almost immediately within the next week or so for this program to commence. Patient enrollment should start as early as March. Maybe it will slip into April, but we will have patients enrolled in this very soon. We only need 100 patients and God knows there are way more than 100 patients available out there right now. We have set up with principal investigators already. This program will predominantly run in the United States. And the desired chemistry is not required to do this. The chemistry is in place, but we will still continue this chemistry program, because we believe that with positive results from this Phase II Trial, we should have data before mid-year, and quite possibly even sooner than that. The trial is only 28 days long and only has 100 patients."
remember this MANAGEMENT: "ALMOST IMMEDIATELY".??!?!??!!?!?!?!
if this is to run predominantly in the US, what sort of trial will go in in Canada? so this will run in mostly canada, or are we still sticking to the plan?
coulda NR'd this last week when this was posted by health canada... STILL WAITING.....
fill in the rest of the missing pieces pls...