hyperopia, I really appreciate you responding to my post about possible candidates for the secondary manufacturing sites for DCVax-L in the UK. I know you're very knowledgeable about cleanrooms. You filled me in a year or so ago about what cleanrooms we had and which were probably up and running, and which still in construction. So I value your suggestions. I don't know anything about Class C cleanroom availability in the UK. In fact, I thought they were very scarce, which is why I thought we'd have to partner with a BP that maybe had them sitting around after trial failures. I agree with Flipper and all others here who have suggested that we'd be better off not to partner with a BP on manufacturing DCVax. I agree I'd rather see partnerships with them over clinical trials.
Flipper, NeWBrO, and a few others have suggested a few manufacturing companies who already have all or most of the licensing and cleanrooms we would need to allow us to move in fairly quickly in both the UK and the US. This is great to hear! We can set up shop and start manufacturing much, much quicker than if we have to build them ourselves.
Yet, it looks like NWBO intends to own at least one facility in each country, US and UK, which sounds like an excellent way to keep control of manufacturing. Afterall, manufacturing is an important part of creating DCVax.
So now it appears that after DCVax is approved, probably manufacturing with the manual method at Sawston, the leased facilities will be used to start commercial expansion sometime afterward. The all important "when" will be determined by when EDEN is completed, validated, employees trained and EDEN units installed in these cleanrooms.
Hoping for approval any day now!
Bullish
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