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The Danish Dude

12/29/21 2:11 PM

#430527 RE: ATLnsider #430523

I have contacted DI in hope for him being able to settle the dispute.
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dennisdave

12/29/21 2:15 PM

#430529 RE: ATLnsider #430523

if they move into another location then the MHRA will have to inspect that new location again of course to see if that new location will hold the standards as set out by the MHRA when they licensed Advent. They cannot just move into a crack house.

The property is part of the inspection as are the required equipment the production process, management, manuals, and trained staff.
Its the package based on what the MHRA granted Advent the license. If one of the requirements were to be reduced, then that could mean a revoke of certificate until its settled. Compare it with a license for a fire department. The department is granted to the organization based on the package of the required equipment, property location, management, manuals, and trained staff.

Now when I was a student, I use to live in an empty fire department, but I do not recall being licensed and allowed to go after fires.



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exwannabe

12/29/21 2:24 PM

#430538 RE: ATLnsider #430523

dennisdave, do you believe that Advent can move to a new location / facility, and still hold the MHRA GMP authorization for producing DCVax?


No. The license is for Advent to manufacture at Sawston.

The real question is what terms has LP agreed to with LP for Advent operating the facility?

BTW, the cert says nothing about DCVax-L.
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Horseb4CarT

12/29/21 4:12 PM

#430580 RE: ATLnsider #430523

No, since the facility and all the processes and training, and the quality, all have to measure up, and that interrelates everything.