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Re: Dan88 post# 413602

Saturday, 10/30/2021 9:28:49 AM

Saturday, October 30, 2021 9:28:49 AM

Post# of 703854
I don't think that is a reasonable ascertain.

So is this recently happened MHRA inspection of Sawston facility is equivalent to the LAST STEP of the DCVax-L approval process, besides the obvious Advent license application?

So is it reasonable to think when MHRA issues a license to Advent, it in effect approves the commercial use of DCVax-L in UK at least?

The Sawston facility must be certified and licensed first before it can produce any drug for commercial use. Once it gets that license, it will be put on a routine inspection schedule of every 2 or 3 yrs. That is independent of a Pre-Approval Inspection (PAI) that is associated and needed for BLA approval and occurs after the BLA is submitted.

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