[quotSo, I'm ready to hear that the first unit will arrive in X-number of weeks or months. Or better, that it has arrived and is hooked up and ready to go through validation runse][/quote]
If it still takes a number of months for the first Eden unit(s) to be validated, do you believe that the MHRA would delay the MAA approval until at least that first unit(s) is validated? That may take months after completion of the inspections that LP had mentioned which may already be taking place right now. I certainly hope that we do not have to wait for approval until December.
I personally believe that the announcement in the Q is enough for approval with artisan but not NWBO and NICE know where this is very likely headed beyond GBM and rGBM so they want to see as much advancement as possible. Having a GMP unit in hand that functions as well or better than non GMP prototypes in my opinion is enough for a green light on approval. The rest should be finished up in the next 16 months. Best wishes.
I say this because the UK, according to statistics, has about 1,500 new GBM patients a year The artisan method will only handle about 500 per year So without Eden units up and running, we immediately start out overwhelmed in the manufacturing of our product.
ACTUALLY 3 yearS ago DEFIES the above: 3200 YR
Glioblastoma is a very aggressive brain tumour with around 2,200 cases diagnosed each year in England (AND around 3,200 across the UK).
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That despite pleas by The MAESTRO for a HALT in trading the collusionary DARK Forces & WallSt prevailed Over the substitute for Dr. Linda Liau NYAS Presentation was Dr Paul McHolland