Riddle me this. “ Management will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) following their review of the interim analysis of the first 195 patients enrolled in the Company’s Phase 2b/3 clinical trial for patients with severe-to-critical COVID-19 indications, including a potential regulatory path forward“
We already all know that the planned regulatory path forward would be to fill trial to 390. This Tuesday webcast must be to discuss another way toward regulatory approval. Most likely one much quicker than filling the trial. We’re in a pandemic covid 2nd wave is already starting to show worse statistics than first wave. If we are told continue to fill trial which is how most all drugs get approved by continuing and hitting Pvalue we may here that the Its in the FDA’s hands to decide on EUA or Approval without finishing trial. If it was just continue trail and that’s it’s I think a Friday after hours p.m PR stating we were recommended to finish phase 3 severe/critical trial. So there def more than meets the eye here. Also if the regular process would be DSMC make a recommendation to the FDA we could very well get the FDA decision over the weekend or as soon as tom. The Tuesday webcast could be to discuss want hasn’t yet been announced.