How bizarre that the placebo group tested so high on reductions, apparently thrown off by results from just 5 out of 54 sites.
"Given that cornstarch is likely not the root cause for the significant placebo response in TRILOGY 1, the Company is carefully evaluating other possible explanations. The Company has noted that a high placebo response at 5 sites (out of a total of 54 enrolling sites) disproportionately contributed to the overall placebo response, and is being further investigated. A full audit of these sites, including review of all raw data and records from patients taking both CaPre and placebo, will be conducted to identify a possible root cause of the unprecedented placebo effect. This audit is likely to take at least several weeks, with an outcome expected by the end of February 2020. Additional avenues of investigation will include further assessment related to specific continuation or discontinuation of other lipid lowering drugs during screening, and changes in the use of other lipid-lowering medications during the trial. Furthermore, the results of the ongoing TRILOGY 2 trial with CaPre may provide additional important information and insight in this regard. If one or more of these investigations provide a plausible explanation as to what may have influenced the placebo arm, and assuming the primary endpoint reaches statistical significance in TRILOGY 2, the Company may still have a path forward to file an NDA, and would seek a meeting with the FDA as soon as possible to discuss all of the TRILOGY data, investigational findings, and obtain their input and guidance on next steps"
