GGB,
If NWBO filed a BLA with the FDA they would certainly PR it. However, if they filed under Orbis, and because of production considerations it was done under the UK, the only way we'd learn of it would be on approval.
Frankly, I don't believe that even today they could submit a BLA that would be validated. Why, because of no production facilities that could pass FDA inspection. I believe that it's possible that on proving the EDEN Unit manufactures commercial quality product the regulators would agree they can be placed in many existing cleanrooms that have all the other things necessary to produce DCVax-L.
I know of no other nation that's yet documented things like hub and spoke manufacturing, but I don't believe it would take terribly long to make that happen. Meanwhile companies like CRL can very probably handle numerous EDEN's in existing facilities that have been approved by the applicable regulators. LP has said much would be announced after approval, I suspect one or more such contract would be among the first things released.
The key, as I've been saying for years, is the EDEN being approved to make commercial product. I have no idea how close they are. I believe that there are many places that EDEN's could be tested to prove themselves, it needn't wait for the new cleanroom to be completed. I certainly don't know but suspect that agencies like the FDA would rather do it in their own labs.
Gary
Bullish
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