Cell Therapy News/Articles, page-17917

I agree completely.

I was out on a limb asking dumb questions- which is a skill in itself

I think there were two types of potency assays in place during the phase lll
The one they used had issues
They reverted to the other one- generated data - included the EAP data - existing lots tested and have got over the Phase lll not being a well conducted trial.

Im assuming manufacturing processes approval incorporates the new potency assay


No-one has shot me to pieces- I wish they would- have a prettt penny riding on this one.

What are the remaining CMC items ? I figure the assay must have been sorted or we would not get permission to refile. Perhaps the unknowns can cause issues as well as final labelling discussions.



Looking forward to the "activities update" - something is cooking


Reg