Steady T, as I understand it, clinical trial material is generally allowed not to be at less than the same quality level of commercial products. I believe that the EDEN is known to be of high quality, the problem is saying it's identical to what's being manually made and approved for both trial and commercial use.
I believe if you're initiating a new trial the EDEN should be authorized as at least being sufficient for the trial. In that no Pivotal trial has ever been established for DCVax-Direct, I would think that the EDEN could be established for where that product would come from.
I'm certainly no expert, just going with what I've been told in the past about such material. On more than one occasion I've seen approvals delayed because the regulator found problems in the production facility, or in the product itself being made in the facility.
I've hated to see approvable products from not being available, sometimes for years, on such technicalities, but I've seen it before.
Gary
Bullish
Market Data 
Markets 
AI
