Q&A with Sarah Re, May 9 2022 News ReleaseMay 27, 2022: GV:
Hello Sarah. This is about the news release of May 9, 2022, regarding the Type C meeting to review the Phase 3 study of apabetalone in high-risk Covid 19 patients. I am focusing on a specific part of the news release which states the following.
" Resverlogix will conclude its Phase 2 trial in hospitalized COVID-19 patients early, thus focusing its resources on the advanced Phase 3 program." What exactly is meant by concluding Phase 2, has it been abandoned, If so for what reason, after so much that was spoken by our CEO Donald McCaffrey from time to time since the program was launched on March 23, 2020, and the millions of dollars spent in relation to Aversana's involvement. To go from this to that so to speak does not explain what is going on and leaves shareholders with complete comprehension. We deserve an honest-to-goodness explanation.
I trust you will provide the best possible explanation of what is meant by, "Resverlogix will conclude its Phase 2 trial in hospitalized COVID-19 patients early, ..." and the reasons behind it. Thank you.
June 1, 2022
(*) Sarah: Hi, GV, RVX in partnership with EVERSANA as announced will conclude the phase 2 trial in hospitalized patients early and to refocus resources on the phase 3 trial where apabetalone has the greatest potential to impact patient outcomes in high-risk COVID-19 outpatients. CORAL will assess safety and efficacy of apabetalone in preventing serious health outcomes in high-risk COVID-19 patients.
Please review newly released data on COVID-19 and the high-risk CVD patient population. Please refer to the following articles:
https://jamanetwork.com/journals/jama/fullarticle/2789793 and
https://www.nature.com/articles/s41591-022-01689-3 GV:
Thank you for that Sarah, however, you have not explained what is meant by, "Resverlogix will conclude its Phase 2 trial in hospitalized COVID-19 patients early, ..." and the reasons behind it. Will Phase 2 be completed as planned, or will it be abandoned, and was anything gained by it that would benefit the Phase 3 trial, or was it a total waste of time and money? Please explain.
Sarah: GV, the study has not been abandoned – but concluded early without completion as originally planned. It is my understanding that any data from this study will be potentially presented at a scientific forum. Reasoning as explained.... (*)
G1945V