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Re: flipper44 post# 511493

Tuesday, 09/06/2022 3:14:01 PM

Tuesday, September 06, 2022 3:14:01 PM

Post# of 730629
Flipper, while I love the way your numbers work out, Dr. Liau couldn't possibly know of a U.K. approval with certainty, but if it were announced prior to her speech, she could certainly work it into the narrative, and perhaps into the slides. As long as the submission was public, she certainly could state that, and that might be something that isn't in the Journal.

I don't believe that Dr. Liau is personally involved in preparing the submission to the regulators, but of course much of the data gathered from the trial where she was Lead Clinician supports it.

If you're correct about when submissions were made, and if approval of the production facility comes shortly, I believe the U.K. is eager to approve DCVax-L and it could actually occur as early as sometime in October. Certainly no guarantee they'll act that quickly, but the key is the okay on production facility, if that's done a month early I'd not be surprised if the regulators acted a month earlier than their target date. If would be unusual for our FDA to act that quickly, but even they could prove me wrong if the other regulators act either with the U.K. or shortly after the U.K. acts.

Gary
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