"“We are very pleased to have confirmed that all the key biomarker endpoints IL-6, CRP, D-Dimer and cPass neutralizing antibodies correlate with the improved clinical outcomes associated with Tollovir treatment,” said Dr. Dorit Arad, co-founder of 3CL Pharma. “With these data in hand, we plan to reproduce the findings in a slightly larger patient population as part of the open label extension. Once we complete our recruitment of a handful more patients , we will be able to present our data package to regulatory authorities worldwide regarding the benefit of Tollovid therapy in addition to standard of care versus standard of care alone .”"

“After review with our regulatory attorneys, we believe that if additional data from our planned open label extension of the study (N up to 46, all to receive Tollovir) are consistent with the data from the blinded, placebo-controlled trial segment (N = 20 in Part 2), we will apply for an Emergency Use Authorization (EUA) in the United States and Europe. Given that the extension is open label, we will be able to look at the data on an ongoing basis as we interact with regulators and submit data as they become available.

So much for the message board experts that said Todos would need thousands of people enrolled, years to complete and millions upon millions of dollars to apply for a EUA in the US.

Yeah baby, they're wrong

https://www.globenewswire.com/news-release/20...ients.html