Andrew, It's my understanding that EDEN has it's own pathway to approval as a device. I know that Les and Linda had always said they would begin with the artisan method, and likely will, but I believe EDEN is well along the way to being qualified/verified (whatever the word is!) for use in commercial manufacturing. Because of the very long time lag since when management and shareholders expected MHRA to make a decision on the MAA, I think there is a possibility (perhaps remote) EDENs have been made and installed at Sawston. We know that two suites were recently validated (right word?) for commercial use. We don't know which class of suites they were, but is it possible some EDENS are already installed and ready for use? We don't know. Is it possible we're close?
Frankly, I don't see MHRA waiting for the annual review of Sawston if a new device is ready for validation now. I think they'd go ahead and approve it, if it's ready for approval and integration into the DCVax-L treatment system.
Keep in mind, EDEN has already passed the equivalency test and been determined to be essentially "the same" as the artisan method. All they need now are engineering runs to be sure the new manufacturing-level EDEN operates properly and passes tests.
So, I'm basically saying/hoping EDEN has advanced to the point of being ready/almost ready to deploy by the time our manufacturing application is decided. Remember, management said in a recent SEC filing that they would begin manufacturing the EDENs to align with arrival at Sawston when the new quicky C-cleanroom is completed. Construction on that c-cleanroom was supposed to begin in the 3rd quarter, according to the Q10. So, construction may already be 4 months in. Almost complete??
Realize that management has never mentioned that EDEN needs to wait for an annual review of the Sawston facility to, itself, be approved.
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