Acasti Pharma Inc ACST

Help with terminology - appreciated

[WalkOverTheStrt]

Any help appreciated.. what does "they *FDA) supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes.".  Does this mean it can be included into the T2 results and factor out those 5 sites or?

Thank you in advance.

[Danny1082Man]

They approve on how the analysis was conducted and thus would consider it's findings when looking at the entire P3 study. Though it still stands that T1 did not meet statistical significance, so it failed as a stand alone study

[Danny1082Man]

And let's remember. Secondary endpoints have already been SAP approved to combine the two studies. Not sure that helps but it's the only ethical way to move forward

[Rosmorduc]

My fear is what I pointed out earlier. Even if the data is pooled together, the anomalies from those 5 labs are still there (for everything put together) so it becomes a numbers game at that point where the pool has to be large enough that the corrupted results will have less of an impact.  Am I interpreting this right? Am I missing something? 

[Danny1082Man]

Totally agree. If we end up with bad placebo data from those sites in both studies can they still hit secondaries which was already SAP configured to pool T1 & T2. No reason why they can't hit primary in T2 since those 5 sites are only 12% of patients....and don't know how many of that 12% were on placebo

[WalkOverTheStrt]

@Danny but the placebo effect was more than at those 5 sites, just had a strong presence more than at other sites...