Couldn't find a thread to put this in, so apologies for starting...

Couldn't find a thread to put this in, so apologies for starting a new one.

There is a large annual meeting of the International Society for Gene and Cell Therapy tonight. There will clearly be discussions on MSc stem-cells with Dr Marks particularly of the FDA at the convention:

https://www.isctglobal.org/home

If you are interested in the science and the regulatory reception, there could be some useful insights.

Certainly some dicsussion of MSc potency assays and mechanisms of action that could be very pertinent to CYP's trial in C-19 ARDS particularly (and MSB of course).

As I posted on MSB, there was a rather unheralded but crucial paper recently published on MSc mechanisms of actions in humans, the first of its kind. This rather addresses some of the concerns coming from the FDA regards these treatments and no doubt the TGA in Australia:

https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-021-02862-x