Acasti Pharma Inc ACST

Placebo Thesis?

[Danny1082Man]

This was posted by someone else on another site..... The reason for unexpected placebo results at 5 sites: Patients with newly diagnosed type 1 diabetes or uncontrolled latent autoimmune diabetes of adults typically also have severe hypertriglyceridemia. We start these patients on basal bolus insulin regimen right away and that also brings their triglyceride levels from almost close to 5001000 down to normal or near normal range. Unless otherwise indicated, we don't necessarily start these patients on TG lowering agents other than statins. That's because we expect their TG to come down drastically with insulin. Insulin activates Lipoprotein lipase; the enzyme that breaks down triglycerides. Patients like these should not have been included in the clinical trial conducted by ACST. This was a unintentional mistake at these 5 sites. FDA will understand this scientific basis of unexpected results in the placebo group. Provided Trilogy 2 results are favorable, we should expect an NDA filing in the fall

[boozehound3]

FDA will ask if the capre group was stsrted on the insulin as well which will put in doubt capre tg lowering ability without another trial.   Trilogy 2 used those sites as well !

[Danny1082Man]

I agree. However, not sure they could have just pulled the placebo group from those sites, to be fair and not cherry pick all patients (36%) would be pulled out of T1, thus the request to pool the remaining data with T2 (minus the 12%) from those same sites. So the question left would be....is there enough patients (over 400) to power the SAP to statistical significance

[Rosmorduc]

Thank you for this valuable information. As we can see, there are many variables when doing these FDA approvals. They never go smoothly.  The key is if it's obvious what happened and the company can provide a detailed report correcting such a sloppy selection of patients. I'm optimisitc they can as they have a lot of smart people there at ACST.