Cell Therapy News/Articles, page-11141

Why would NIH continue to fund trials for therapeutics if this were the case?

I suspect there is a lot going on behind the scenes that we aren't aware of. It could be that the U.S. government is very interested in Remestemcel-L as a treatment for Covid - so much so that they might throw some resources into supporting a massive expansion in production. This could be justification for not granting an EUA right away. They may want more robust clinical data before throwing a lot of resources our way, and having an EUA in place could make it difficult to do a double-blind trial. Who would risk being the one to get placebo? Given the massive need and limited supply, they may be willing to sacrifice some lives today in order to gather evidence to allow for massive production and targeted dosing that would enable them to save many more lives in the relatively near future. If there are discussions such as this, with BARDA, this could also explain some of the delay in finalizing the Novartis deal.

A reminder of the discussion following the initial release of results:

Jason Kolbert, Dawson James:

Silviu, Josh. Thank you very much, very exciting data. Louise asked some great questions. I'd like to ask you, given the fact that you have such prominent people on your board like Dr. Eric Rose, who's pretty connected with the United States government and BARDA, and DOD, what kind of discussions have been going on there? How aware, you know, is the government of this data?

Dr. Silviu Itescu:

Jason, I think, I think it's very early days given that the trial was halted in November in the third interim analysis, and I think we've only just unblinded the data and have had an opportunity to see the top level results. And of course given the materiality of the mortality reduction that we have observed, it was important that we get this information out there. The objective over the next short period will be of course to meet with the FDA, to talk at a higher level with governmental agencies, and I guess the real question is going to be how robust are these data and what degree of confirmation needs to be observed in order for the next steps to be placed. I guess, when we talk about BARDA, we talked earlier about contractual arrangements for manufacturing scale up. In order to think about those type of things, we need to have our plans in place, and that will require FDA discussions as well as further discussions with our potential strategic partner Novartis.