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Re: exwannabe post# 497675

Sunday, 07/24/2022 4:11:14 PM

Sunday, July 24, 2022 4:11:14 PM

Post# of 704213
I dont understand quite of what you are saying

1. Of course Advent wants a commercial GMP license to then be able to commercially produce DCVAXL. Thats what I said when I responded with 100% agree in the post you responded on. As what it now looks like its the only way for Advent to commercially survive, so far I have not seen any other evidence of any other Advent client, NWBO is the only client.

2. Advent ofcourse must have that commercial GMP license prior to DCVAX L being approved. So thats why its now in process.

3. The question as part of the discussion here was/is, is NWBO required by MHRA rules/reg to apply for approval of DCVAX L in order for Advent to get its GMP license. The answer to that is no. Advent could get its manufacturing license even if DCVAXL would not exist. This is important timeline-wise for there is, unfortunately, no rule/reg pressure on NWBO to submit a request to approve DCVAXL asap, as Flipper said, in order to unnecessarily waste MHRA time.
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