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Bullboard - Stock Discussion Forum
Acasti Pharma Inc
ACST
Healthcare
Acasti Pharma Inc. is a Canada-based late-stage biopharma company with drug candidates addressing rare and orphan diseases. The Company is targeting three underserved orphan diseases: GTX-104, an intravenous infusion targeting subarachnoid hemorrhage (SAH), a rare and life-threatening medical emergency, in which bleeding occurs over the surface of the brain in the subarachnoid space between the...
brain and skull; GTX-102, an oral mucosal spray targeting ataxia-telangiectasia (A-T), a progressive, neurodegenerative genetic disease that primarily impacts children causing severe disability; and GTX-101, a topical spray, targeting postherpetic neuralgia, a persistent and often debilitating neuropathic pain caused by nerve damage from the varicella zoster virus (shingles). The Company’s clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection.
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Bullboard (NDAQ:ACST)
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(52)
•••
Francine01
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Comment by
Francine01
on Jun 22, 2020 1:13pm
RE:RE:RE:TRILOGY 2
My view is that as of today, nobody (no retail shareholders), except management (and friends and families!) knows exactly what happened with T1. We are speculating since January, unfortunately we
...more
(75)
•••
QualityTest
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Comment by
QualityTest
on Jun 22, 2020 11:12am
RE:RE:TRILOGY 2
Walk, Glad you pointed out that this issue isn't necessarily confined to 5 sites. I don't believe it is actually only those 5 sites, but just that those 5 sites had a large % of T1 patients
...more
(61)
•••
WalkOverTheStrt
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Comment by
WalkOverTheStrt
on Jun 22, 2020 9:48am
RE:TRILOGY 2
Danny like te optimism but this assumes that those issues will not be observed in sites outside those 5. Bc we have been kept in the dark on what happened we do not know if the issue/error/lack of
...more
(63)
•••
hydrocarbss
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Comment by
hydrocarbss
on Jun 20, 2020 6:29pm
RE:TRILOGY 2
Thanks ever so much Danny...pulling the data apart to get our own understanding... From a couple of PRs. As previously reported, the Company noted a highly unusual placebo response in its topline
...more
(13)
•••
Danny1082Man
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Post by
Danny1082Man
on Jun 20, 2020 5:21pm
TRILOGY 2
281 patients randomized 2.5:1. CaPre dosed would be 200 and placebo 81. The five problem sites represent 12% or 33 patients. If randomized as stated that would be 24 CaPre and 9 placebo. There are 81
...more
(13)
•••
Danny1082Man
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Comment by
Danny1082Man
on Jun 20, 2020 1:45pm
RE:Do the Math
Trilogy 1 would have 175 on CaPre and 70 on placebo. So you would need 36 high placebo out of 248 subjects to torpedo the study. How many of the 35 placebo were at those 5 sites? That's the golden
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(13)
•••
Danny1082Man
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Comment by
Danny1082Man
on Jun 20, 2020 1:38pm
RE:RE:RE:RE:Do the Math
Exact reason why the call on the 29th is so important. How many placebo patients were at the site? Could, we hope, a disproportionate amount were from there, or that will be a huge concern
(13)
•••
Danny1082Man
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Comment by
Danny1082Man
on Jun 20, 2020 1:36pm
RE:RE:RE:RE:Do the Math
2.5:1 is full study. Some sites only have a couple of patients
(1964)
•••
lscfa
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Comment by
lscfa
on Jun 20, 2020 9:57am
RE:RE:RE:Do the Math
Does each site maintain the 2.5-to-1 ratio or is that a study wide goal? If study is truly double blinded then ratio may vary from site to site. Did the 5 bad sites have a higher no. of placebo
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(63)
•••
hydrocarbss
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Comment by
hydrocarbss
on Jun 20, 2020 9:57am
RE:RE:RE:RE:Do the Math
Thanks, did this after staying up all night...
(1964)
•••
lscfa
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Comment by
lscfa
on Jun 20, 2020 9:42am
RE:RE:RE:Do the Math
25 Patients Pacebo
...more
(1964)
•••
lscfa
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Comment by
lscfa
on Jun 20, 2020 9:34am
RE:RE:Do the Math
Study Description Go to Brief Summary: The primary objective of this study is to determine the efficacy of CaPre 4 g daily, compared to placebo, in
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(13)
•••
Danny1082Man
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Comment by
Danny1082Man
on Jun 20, 2020 7:37am
RE:Do the Math
And your assumption I believe is wrong. They take the median, not the average of placebo reduction
(13)
•••
Danny1082Man
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Comment by
Danny1082Man
on Jun 20, 2020 7:35am
RE:Do the Math
I will have to look it up but I thought the number of patients assigned was 2.5:1 for CaPre verses Placebo
(63)
•••
hydrocarbss
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Post by
hydrocarbss
on Jun 20, 2020 6:28am
Do the Math
We aren't given the exact breakdown for the Trilogy 1 trial. So will use approximations. Trilogy 1 enrolled 242 particpants 121 in the placebo 121 in the Capre
...more
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