Hi Lykiri.
Yes, I've trawled through that EUDRact listing previously.
Not noticed the apparent numerical discrepancies though.
However, the planned ITT number has rather gone up and down a bit from 312 to 348 to an eventual 331 (courtesy of FDA) so it doesn't surprise me that allocation per country figures might not tally, and I don't read too much into it.
Though it would be interesting to know the actual breakdown by country.
I'm not sure what to deduce from that statement under F.5.
But I think you spotted it was the Germans who somewhere listed shelf life at 3yrs.
I still think there was a technical issue that cropped up unforeseen; something to do with dosing, and possibly related to shelf life. I've never thought the hold was related to either efficacy or a specific adverse event that might call into question safety.
More of a niggling technical issue that LP thought would be resolved in quick time. In fact, it was never stated that a hold was imposed. Rather it was stated that screening was suspended.
Which could have been an agreed course of action between NWBO and FDA, rather than something unilaterally imposed by the regulator. But regardless, the effect was the same and, in the event, it took 18 months before matters were resolved to the FDA's satisfaction..
I still think it might have been the FDA insisting on real time testing of product life. But that's just a theory.
It would be an interesting exercise to compare what they have said about product life over the years pre and post hold and whether the wording has changed.
Certainly in Jan '19, they described shelf-life as 'validated'.
Did they use the term 'validated' before the hold, I wonder?
The 5-ALA issue is interesting. Although Prof Ashkan has had it at Kings for 8yrs apparently, it is not currently widely available for Neurosurgery in the UK. Only a handful of hospitals currently have it. And I've no idea now many of the UK clinical sites had it or used it. Though in the wake of Tessa Jowell's plea for wider availability (in the time before her death), there has now been a Govt. commitment for a full roll out.
NICE has also completed a cost/benefit analysis concluding that it should be made available across the UK.
And then there is the issue of whether the use of tumour-staining affects whether or not the tissue can still be used in production of DCVax. I sincerely hope that the tissue can still be used, otherwise they have a bit of a sticky issue on their hands, going forward..
Regards
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