Hi Gary, that was a risk factor in their financials at one point, the point being that there is no hard and fast rule for biologics that they be manufactured in the United States, as far as I know. Those making such a claim should post the clearly stated rule with a full set of links.
I believe the FDA views certification by the MHRA and the EMA as good as their own. Though there is likely an additional step of some sort of review of the specifics of the process and drug that adds a little bit of uncertainty.
In that instance, there is likely a case by case review of potential risks and issues for supplying to the US and the FDA certainly might make such a determination on a discretionary basis. However, I believe the company’s statements that they are focused on Sawston gives you the clear indication that they, their lawyers and the interim advice they were getting (informal likely from their various regulators) had indicated that initially they could rely upon Sawston.
I agree that they could likely set-up a facility fairly quickly here if they do not need clean rooms and can use the Flaskworks technology to set up an automated facility. Approval of their commercial manufacturing application in the UK will likely kick off a set of discussions because I believe that eventually they almost certainly will want a facility here in North America somewhere, maybe even Canada. Approval, or some event likely leading to approval, could also be the subject of a pending commercial deal or partnership that triggers upon approval or a similar contingent event.
Manufacturing is certainly a major aspect of approval, but typically the things that really trip these companies up is not really usually capacity, Car-T capacity is limited, we know that already. Often capacity is an issue for accelerated approvals where the drug is basically accelerated because it will be the new SOC. I think we do expect this to be SOC, but usually the holdup for approvals with the regulators is most often consistent quality. Do think they want their potential for competitive and reasonable pricing to set expectations from the beginning however. As for quality of production, I have seen nothing so far to indicate that is an issue. I think it is all about capacity and I think they will be able to create a lot of capacity, the issue is how large the demand, and also any issues the FDA may set on a discretionary basis regarding transport of the various inputs and if being in the US will be a requirement. I don’t believe that is a hard rule though.
I expect that they have this issue well in hand for now. But that they will need a plan for getting the resources to expand quickly upon approval. That can come in many forms. They are studiously avoiding Dendreon’s errors and that should count for something with the FDA even.
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