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abc1212

11/12/21 11:23 AM

#417046 RE: Lykiri #417000

Thanks again Lykri for all your DD

Not sure if anyone has asked this before,

With regards to the 'Specials' license
Is there a limit on the number of patients that can be treated under compassionate use or is it unlimited

As for

The day the licenses to manufacture DCVax products at Sawston are issued by the UK Medicines and Health Products Regulatory Authority (“MHRA”)to Northwest Biotherapeutics contract manufacturer and operator of the facility,
Advent BioServices, a legal and regulator-approved revenue machine can start.


This will surely take massive pressure off finances and at the same time help towards uplisting.


Regards


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Doc logic

11/12/21 12:06 PM

#417059 RE: Lykiri #417000

Lykiri,

Quality control and quality assurance in smaller companies can be done by the same person so looks like that one might be taken care of. Production department responsibilities are separate. Don’t know if that is locked down to satisfaction yet. Best wishes.
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flipper44

11/12/21 12:11 PM

#417062 RE: Lykiri #417000

Thanks again Lykiri!

However, it should be noted that the processes are independent of one another and an MIA and or GMP Certificate must be in place for the manufacturing facility before the Marketing Authorisation can be granted. — Richard Parker
Senior GMDP Inspector
Inspection, Enforcement and Standards

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MI Dendream

11/13/21 12:25 PM

#417351 RE: Lykiri #417000

If everything is hunky dory which I expect it is, then I agree that Advent may well be the best alternative available to us at that time and with that funding. It could be a brilliant way to offer herself and her colleagues backside protection if things go well, meanwhile providing current shareholders much value.

If it is not, then there is a different lens by which we should look at these decisions because if we pass SNO bye without proper disclosure of material information to retail investors there begins to be questions asked which do not lead to protection of current shareholder value (and I mean current as before warrant extensions). If there are problems which are leading to delays, then we have a right to know just as much as any single one of those warrant holders and I have two paid advertisements that say so, unless some other more timely avenue is available to them. Journals do not prevent presentation at Congress from my experience, but the reverse is not necessarily true, and besides why would you especially after telling me that you would through paid advertisements. I am not making a threat, I am making an observation and there is a big difference.

I don’t want to slip back into negativity as I wish to let those feelings go and listen to my yoga instructor when he says that you find peace by accepting and trusting in the unknown.

There is a third pathway with many doorways to choose. I will continue to provide options in my free time at no charge to anyone who cares to read.