I think in the context of your answer the following conflicting points, recognizing we are all still somewhat in the dark:
1) as I have said, I had been thinking they would lead with the FDA as a general proposition based on my own expectations and thought process;
2) I now think the UK is surprisingly ahead of the US on the most advantageous reforms pending here but not yet implemented;
3) the challenge with your view on the quiet period is their mandatory disclosure documents that clearly point hard at a focus on facilities and efforts in the UK, though I have made the case for Cognate and my view that doors and routes remain open, I do not agree that looking at the broad picture including what they say there, that that indicates manufacturing is standing in the way of the FDA currently or that US manufacturing is a major issue at this moment. It suggests to me they are creating the demonstration effort to show a practical scale up plan, they are not spending the capital to be ready at this moment or this time to immediately meet the demand of being the SOC. My reading of the rules for qualifying for accelerated status even in the US and thus then for Project Orbis is that that is actually likely all they need. Moreover, the MHRA’s more finished process for acceleration would also qualify them for expanded approval in other jurisdictions AND for Project Orbis. In other words, the MHRA has a very well articulated program for doing what we have been thinking had to be done through the FDA, but may be more broadly coordinated with the partner agencies in ways not entirely anticipated by any of us on bulletin boards, though many have suggested they are going with UK first, the reality is it may be more intertwined and complicated than that in some ways but also more simple in the context of a partner agency with acceleration reforms already in place that are substantively quite similar to what the FDA is getting into place but which are still in draft form.
4) I agree, they can’t talk about TLD because of the quiet period, and it is very possible that regulatory processes are in fact proceeding, I just think now that there is a good possibility that the easiest route forward for all the agencies and the company may be through the UK. The end result may still be a simultaneous approval, near simultaneous approval or even a deferential allowance for FDA to approve based on work done in the UK mostly with the MHRA.
I think these coordinated efforts tend to involve novel issues of multilateral coordination. So it may be unclear to many of us from our vantage point and they may all really be feeling their way to the right answer, the answer that feels right for all of the regulators.
I hear you on the quiet period issue. I just think people are wrapping too many issues into one issue and in many instances they are more separate than it seems though at the end of the process and day, they all need to line up properly.
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