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Re: flipper44 post# 433826

Monday, 01/10/2022 3:21:20 PM

Monday, January 10, 2022 3:21:20 PM

Post# of 821336
It’s like circular reasoning around here. Yes, and the process for the next level of they need more space or to expand beyond the annexes and to make the product commercially is not likely a huge hurtle blocking current progress. The product is licensed for human use, scale is another matter but something that is addressed in the course of things, in terms of current production. Once they have Flaskworks certified likewise the choice of what to put where and to expand is likely acquired in the course of regular dealing with the regulator, and is likely not a huge block to current events like the release of TLD or BLA approval. Most regulators need a practical plan that is reasonably executable not the full facilities at this time.

I expect they might need to show they can do the full scale up financially, and could have a partnership or plan, most likely completely secret, based on certain milestones that would allow them to show they have a scale up plan. Those milestones likely would set a valuation to make the scale-up acceptable to everyone.

So I think some things may be predicated on other things, but that the likely driving force with the regulator is about having an executable and practical plan, not necessarily about validating technology or further licenses, etc.

So I think more likely there is something they need to validate for a potential partner or acquirer, that would justify an investment that would make scaling, beyond the technical issues, not an issue of worry for any regulator.

But I am purely speculating. I do not think the barriers people keep suggesting are an issue, I do think they are likely working on multiple fronts, 1) to finalize and publish TLD, which I believe can drop at any time; 2) having accelerated status; 3) preparing and filing their BLA; and 4) having their financial house in order, whether via partnership or buyout, at an LP determined reasonable price. I think we are seeing efforts at many levels and it’s not always obvious what efforts relate to which things they are working on and of course they are all intricately connected. I think it is not easy for most to figure this out.

I think they are multitasking well and we will hopefully see results soon.
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