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Re: flipper44 post# 301907

Monday, 08/24/2020 3:38:42 PM

Monday, August 24, 2020 3:38:42 PM

Post# of 731864
There is an elephant in the room if Advent wants to supply the EU.

At present, if a drug is imported into the EU then it must have a QA test on each batch after it enters the EU. Not a huge issue for most drugs and biologics. But for DCVax a batch is the single agent dose. And this would be a prohibitive cost issue.

Of course UK and EU might end up playing nice. But LG has stated he knows otherwise, UK will go it alone.

Now, if UK does what some expect and sign a deal to remain a party to the EMA then this might change.
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