I believe this is the crux of the problem, except in the UK where manual commercial production has been approved. It's possible that growth in manual production facilities in Sawston, or elsewhere, will meet FDA and other regulators initial requirements, but we have no idea if that's is being proposed to the regulators.
Until LP, or someone at the company, provides some information on what their approach to commercial production is WRT each of the regulators, we're purely speculating on the EDEN unit being required, or not.
One thing is certain, you cannot submit an application for approval to a regulator until you at least have a commercial production facility that will be available for inspection during the period the application is under consideration. If the facility isn't completed on time, approval could be delayed until it is, but it's more likely that the facility is complete, but if changes are demanded by inspectors that can delay approval. In the past I've seen approvals delayed by both production facilities and shelf life problems where the regulators agreed on the benefits of the product they were examining.
I expect that when the company is ready to go for approval we'll also see a formal relationship for commercial production announced with CRL in addition to the existing one with Advent.
Gary
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