About the whole "new data" thing. Besides the additional EAP...

About the whole "new data" thing. Besides the additional EAP patients, we have the covid trial.

Just want to remind folks of this exchange from the 30/04/2021 webcast:

John Hester, Bell Potter:

Okay. Okay. And you've alluded to confirmatory studies, but the reality is, you've now got data from a 222 patient, randomized study. And at the time of the GVHD decision from the FDA they were indicating that they wanted data from a randomized study, to what extent do you think this will go towards satisfying that requirement?


Dr. Silviu Itescu:

That's a very very good question. We are in ongoing discussions with the FDA with respect to this very product, Remestemcel-L, and its pathway to approval for children with the most severe forms of acute, steroid-refractory GVHD. This trial certainly provides evidence of biologic activity of the product in a randomized, controlled trial. Again, it's important to note that the trial was relatively small, and we see a treatment benefit in the pre-specified population under 65, but not in those older than 65. So there continues to be the requirement for confirmation and more studies. But nevertheless, in this randomized, well-controlled, well conducted study, we see strong biologic evidence of activity in patients as defined by reduction, substantial reduction in mortality.