XM and all who've written about Orbis, do you understand it as I do. I believe that early on Orbis is applied to, I don't believe that acceptance is to be public and likewise, I believe it's to be treated with secrecy through the entire process. It would be up to the regulators to say requirements of Orbis have been met, or if a company must apply individually to each regulator.
If the above were true, wouldn't it be smart for the company to be told, apply to the UK, or other regulator, rather than FDA. Also, at the time of the application, commercial production capability wouldn't meet Orbis requirement, but time could be given to develop that capability.
I'm not saying that this has happened, only pointing out that if this were the case, wouldn't it be a scenario that maintains the secrecy that I believe is intended in the Orbis process. Frankly I don't know what, if any, products have officially been approved through this process. Does anyone know which products have?
If by chance this is the case, it would have a lot to do with the time being taken in revealing the decision. While I hope it comes soon, if it involves acceptance by Orbis, if it's to take longer, I'm fine with it. As I see it, the acceptance of the EDEN Unit would be a part of the entire acceptance as without it, commercial production doesn't exist to serve more than the UK, and it will not fully serve it.
I'm sure that the company knows if this is the case, they would no doubt be corresponding with all regulators if that was the case, not just those from the UK. Again, if it's to be kept secret, they'd have fulfilled their part of the agreement. For those critical of the lack of information from the company, that too might be understandable if Orbis was a consideration. I would suspect that at any time during the process a decision that Orbis won't be applied could be made, so a start under Orbis doesn't assure completing the process.
Let's see what the next week brings, we begin a new month on Thursday, whether a decision is revealed this month, or next, I really don't think it will go beyond that, but as always it's JMHO.
Gary
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