@ col69 . Ask your self, would it be wise to start a trial, any trial when the FDA has not shown commitment in approving a off the shelf product like the GVHD treatment?
The clinical data is compelling for GVHD in both children and adults and the same goes for CLBP.
IMO, AA is a must for clinical development to continue in the US.
Many may think that we have not progressed CLBP, we have, the 3D manufactuing patent and the potancy assay patent were for the CLBP product. Huge amount of work has been done. I would not be surprised if this work has not changed the way FDA would look at the current CLBP data , in the same way they have moved on the GVHD data.
banter and General Discussion, page-8326
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