Countdown to Interim Analysis, page-78

From the interview by Alan Kohler on 30th of April this year I may quote a few fascinating stuff that The Prof tried to inform us regarding the trail and manufacturing while we wait...

"The FDA is very familiar with our product. They've got all of the historical data in hundreds of children and previously adults. And we've leveraged that information especially around safety and around the fact that GVHD is a very similar disease in terms of immune activation, as is coronavirus in the lungs and with all that information together, we went to the FDA to seek their approval to get going...

What our cells do is they're the body's natural control mechanism for excessive inflammation, if you will. They have receptors for these aberrant cytokines and when you put them in the middle of, what's called a cytokine storm, they're activated by these immune cytokines and then they turn off the very cell that secreted them.

When you inject our cells intravenously, the first place where they migrate to, are the lungs. So inflammation in the lungs is an ideal target for Remestemcel-L...

And we're talking to the US government around the potential for the government to support our manufacturing requirements in terms of investment both at the level of capacity and at the level of supply purchase.

And so we've got ways of increasing the production levels by anywhere from 10 to 20-fold that will substantially increase capacity and reduce the cost of goods and obviously have a great impact on gross margins. So we’re well positioned to meet the supply…

The primary objective is to have something we hope that offers the possibility of surviving this because without something like the strength of our cells, there's nothing else that has a chance that we can see at the moment, of switching off inflammation. Many things have been tried. None have succeeded."

Now with this statement of conviction:

"I think given the totality of the evidence, including the many hundreds of patients we’ve treated with acute Graft Versus Host Disease, a very similar cytokine storm disease, we're very confident that what we're seeing here are signals that are going to point to us being successful in our Phase III trial."

Can you not to be confident by this...?!!

Dyor & Glta