Acasti Pharma Inc ACST

TRILOGY 2

[Danny1082Man]

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 total placebo so getting to a median number where it needs to be seems attainable and likely

[hydrocarbss]

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 triglyceride reduction primary endpoint, far greater than seen in any prior omega-3 triglyceride lowering trials, with 5 sites out of the total 54 enrolling sites disproportionately contributing to this

[WalkOverTheStrt]

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 following protocol/study design caused this... so to speculate that only five sites are of a concern in T2 is not a prudent thought practice...

[QualityTest]

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. This is from the Feb 10 NR "with 5 sites out of the total 54 enrolling sites disproportionately contributing to this placebo response". Acasti didn't say that those 5 sites were

[Francine01]

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 have no clue ! all hypothesis are true and/or false. We can only hope than the T1 F*** up, is small (related to only 30 placebos / 5 sites), so obvious (statin hypothesis), will be remove from the NDA

[ferraridan]

Francine: I don't agree saying it will be end of speculation on June 29.  To recap: - The FDA did not allow modified statistical plan to remove the 5 sites so in that sense we did waste our time since January although I think it was a good idea to try nonetheless - They will allow a post hoc analysis without 5 sites for info purposes only - T1 failure to meet endpoint stands as is and on

[WalkOverTheStrt]

Francine - Agree too soon to report T2 results, I am guessing end of July / early Aug.  Also spot on that FDA did not agree with removing T1 5 sites. Surprised with how many here are trying to spin that....

[Danny1082Man]

Ferridan, Absolutely if we get transparent audit it sheds a blaring spotlight on the potential success of T2. We deserve clear data points on all T1 patients. What sites had placebo in it, how many at each site, what caused the error, was that causation isolated at just those 5 sites? Just give me the damn data points and I can give a solid statistical model on the chance of seeing success with T2

[WalkOverTheStrt]

QT good catch and this aspect makes me even more weary to hold my shares... At one point the PPS approached $1 whcih is my breakeven and I didn't pull the trigger. Then again i didn't pull the trigger when I was up at high $2 off a .88 pps... Should have known mgmt would muck it up regarding their over confidence...