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hoffmann6383

05/11/23 12:10 PM

#592458 RE: exwannabe #592456

No comment on how close it is.



It's complete. Read the 10q.

Have a good one friend!
Bullish
Bullish
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flipper44

05/11/23 12:14 PM

#592460 RE: exwannabe #592456

“Wonder if London has been using the exact same process as in the trial, and that is the reason it is still open. Not for capacity, but for a reference process.” — ex



That’s what I think, and let’s be real, Dr. Ashkan is probably still the point man on all U.K. specials, so there is a bottleneck of sorts there. Without advertising, and advertising being even more constrained premarket due to specials, the 47% increase in specials is de minimus but not insignificant given the current unreimbursed status and relative silence.
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CaptainObvious

05/11/23 12:45 PM

#592470 RE: exwannabe #592456

Good question. Seems like an expensive way to do it, though. But it would be better since it's done at a facility that is at another location that could be considered at arms lengthish.
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hyperopia

05/11/23 8:02 PM

#592567 RE: exwannabe #592456

Yes of course London was using the exact manual process that was used during the trial - it was the the legacy process established by Cognate that was used to manufacture for compassionate use in the UK. That manual process was then transferred to Sawston for the initial investigational license there.

I can’r recall if London has a commercial license. If it’s only an investigational license, then Advent could manufacture for the pediatric trial or another small trial there. That’s the only reason I can think of to keep the facility open using an obsolete, less efficient, manual process. I think it’s likely the new established semi-automated process will be transferred to London and used to apply for a commercial license if it doesn’t already have one, and then the facility could be used for extra commercial capacity, or for small clinical trials.