Hopewillhelp
1 year ago
Nobody watches this stock and that's a mistake. 12 month minimum for full data analysis but we can get the interim data analysis much sooner. There was 125 patients enrolled in the Canadian P3 and that was 2 years ago. Recently, the Canadian P3 and the US P3 have been harmonized and the patient protocol has been changed to 600 total patients from the original 800. We could be closer than we think. Upon that data, the shares will double or triple, if I were Par, I would apply for EUA and the shares will rocket even further. He can then do an offering at a much higher valuation, and start the P2 Vitligo CXL-10, and EBO5 Fibrosis trials.
subslover
3 years ago
Edesa Biotech announced final results from the Phase 2 portion of its ongoing Phase 2/Phase 3 clinical study. This study is evaluating the companyβs monoclonal antibody candidate, EB05, as a single-dose treatment for hospitalized patients with or at risk of developing Covid-19 induced Acute Respiratory Distress Syndrome (ARDS). The company previously reported initial topline data provided by the studyβs data safety monitoring board, which preemptively unblinded certain study data for efficacy signals. Edesa has now completed a formal Clinical Study Report (CSR) for U.S. regulators on the full, validated Phase 2 dataset.
Trial results: In the final Phase 2 clinical trial results, Edesa reported that EB05 demonstrated a statistically significant and clinically meaningful trend for mortality and survival time for all randomized subjects in the critically ill cohort (the intent to treat, or ITT, population). Today, the company reported a revised 28-day death rate of 7.7% in the EB05 plus standard of care (SOC) arm versus 40% in the placebo + SOC arm in critically severe patients on ECMO therapy (extracorporeal membrane oxygenation) or Invasive Mechanical Ventilation (IMV) plus organ support with ARDS at baseline (p=0.04). The revised Survival Analysis using Coxβs Proportional Hazard Model demonstrated that patients treated with EB05 plus SOC had an 84.0% reduction in the risk of dying when compared to placebo + SOC at 28 days.