Post by
general360 on Nov 04, 2021 2:22pm
timeframes... :(
on to the business at hand.... trial timeframes... i'm seriously watering down the expectation here on how long it'll take...
i'm guessing/spitballin, or generally just ballin.....gotta make some big assumptions - as usual - given the lack of info from the company.
trial between Canada and Brazil... assuming 50/50 split? or ruffly so, maybe 55/45 or 60/40.... but pretty close to 50-50.
and of our Canadian "half" - clearly since we're being somewhat miseld, we're going to have a breakdown across the country, and we've only got 1 of ???? we dont even know how many other sites we're wating on "due to confidentiality". so our Edmonton/region might only be 1/3, or 1/4 or thereabouts (Ontario? QUEBEC) , so we'll max out at 1/3 or 1/4 of our half from canada. we're stuck waiting on approvals from the rest of the country, then we gotta ramp up in those spots, which is clearly taking a month or more at this edmonton site alone?!!?
on to Brazil: i was just reading something that i'll have to dig up where, but there are problems in brazil w/ running these types of covid trial. the issue was there are all kinds of settings which are handling COVID cases other than hospitals. its not as rigorous as usual clinical trials. led me to have the impression that its a problem w/ some of the results specifically from Brazil. shoulda grabbed the link....
so it sounds like we're months and months away from filling up to 100.
Canadian sites; vs # of patients per site?
1 50?
2 25
3 16
4 12
5 10
total time looks like its gonna be MONTHS as each site is seemingly approved, at almost 1 by 1. it would be beneficial to see what the exact pathway is before we can start talking about accurate/full timeframes.
we've received 1 of XXX ethics approvals in canada-
there is a total of 3/4/5/ REGIONS in Canada, with XXX sites per region
waiting on 1 of xxx approvals in brazil ;
there are a total of XXXX regions in Brazil, with XXX sites per region
yeah, i'm thinking it'll be 6 months or longer for full enrollment. not sure what provisions are built in if say we get to 100% capacity at one of the earlier sites and if EVERYONE walks out after 48hrs or so, can we halt the whole trial w/ out even starting elsewhere?
still dont know what these other "Countries" coming online are gonna do for us. Morocco is a country. the council is just that, a council, not a country. so we're either nitpickin and being critial and boohoo jaded when we point that out, or we're still waiting on another country cause DM said 2.... the one NR says "for the launch of clinical studies" for morocco, so either thats a part of our P2 Canada/Brazil, or perhaps the P3 USA/FDA trial coming "in a few months" and "end of the year", which i also thot he said some time ago "after the P2 in Canada" which i still think will be MONTHS and MONTHS away so P3 next year, june or later, like they also said in a recent prezzy....
just trying to be realistic and head myself off at the pass...i'll still go ballistic when DM spews filth about "any day" and "soon"...
Comment by
G1945V on Nov 04, 2021 3:49pm
Covod 19 as much as we are told does not discriminate in any way, shape or form. So why does it matter where the Covid 19 infected specimens come from. Just dose Covid 19 patents where ever they are as this is only an open-label Phase II trial to evaluate the safety and what effect apabetalone has on Covid 19 infected patients. G1945V