Thursday, February 22, 2024 3:22:39 PM
I suspect that deals that formalize CRL and Advent as being the primary supplier of the vaccine worldwide and leasees of the EDEN units to do so are ready to be signed, sealed and delivered, but await one singular event, the acceptance of the EDEN unit to commercially make the vaccine. Certainly I could be wrong about this, but I believe that's how the company is planning to operate.
Sawston already can make the commercial vaccine manually, but capacity is quite limited and while some may disagree, I don't believe it sufficient to satisfy FDA requirements. I'm frankly uncertain if European and/or Canadian requirement could be met with Sawston as is, nor do I know if language already exists with Advent on using the EDEN when they're approved for use.
Hopefully in either the Annual Report or Annual Meeting we'll get further guidance on this, the recent announcement on the EDEN is a positive, but still leaves us unsure of how much longer it will take. If I'm wrong, if sufficient suites of cleanrooms would permit FDA acceptance of the facility, then an FDA filing could be made at any time, likewise the other regulators. If I'm right, all but the UK may await EDEN acceptance.
Gary
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