Hi Doc,
I think you are missing my point, and my apologies, if my distinctions are not all that clear. I do not think their validating the automated manufacturing is holding up the process right now, because those matters can be discussed later in the process of approval. Right now, the issue is accelerated approval for relevant agencies (hopefully leading to Project Orbis and its similar program in the UK) and release of TLD. I believe they can get that status and introduction to Project Orbis via the UK as well as going through the US door. I believe the company has weighed the two doors and may be leaning toward the UK doorway, but either way, it's good.
For accelerated status, and it is often granted much earlier, you need a plan for scaling manufacturing, and they have that, but again, I do not think they have not announced TLD because they are waiting for accelerated status, I think they likely have status and the process for these multiple agency processes is that they must keep all of it confidential, I believe. So I think that is one reason we're not hearing about, for instance, if they got RMAT or some other accelerated status. I think it would be confidential if they were invited to participate in those programs this late, based upon achieving such status. Might not be true, it's my opinion after reading much.
I think they clearly have a plan and have had one for some time. I just do not think that at this moment, for where they are, likely there is a hold-up related to manufacturing and if it was integral to releasing the TLD and other matters, manufacturing would also then likely be subsumed into the confidential category and part of a quiet period hush. I think they are proceeding in an orderly and expedited fashion with regard to getting everything ready and set for validation for a reasonable scale-up plan and who knows, but that plan may even ultimately involve a confidential deal with another party to fund or manage the manufacturing when the time comes, we just do not know. That may be why they have remained flexible on scaling up Sawston fully.
I do not think the FDA or the MHRA or EMA require they have it all fleshed out today or tomorrow or before it is all processed, other than a very executable and practical plan and some initial facilities because they recognize that these small companies rely on the regulatory process to proceed before those deals become fully implemented. They might have letters of intent or similar maybe that they could convey in some fashion, I would guess. But I also expect that the FDA understands that they understand that they can't make any misrepresentations on such matters as they proceed in the process or that will make their application radioactive. So there is likely a good amount of trust on plans and the agencies also likely do enough due diligence to know and feel comfortable that plans not yet executed fully are still practical.
So I basically think they do likely have a lot of potential things happening in the background. I do not know what, but I also don't think some practical matters are standing as barriers at this moment. And I think they are likely in a good position to proceed forward very soon, just judging from things we are seeing publicly happening, the certification of Sawston, the new FDA paper with high level authors on a highly pertinent matter with regard to the final measure of efficacy, though it's not a final version of the guidance, it is suggestive that the policy is taking a firm hold at the FDA (we will see what else may come yet). I think things are falling into place.
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