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Alias Born 08/14/2003

Friday, June 17, 2022 10:31:00 PM

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I was thinking about what the worst case scenario might be, I believe we'll get U.K. approval shortly, very probably before the end of this year. Europe and Canada will follow shortly after that. The worst case scenario, as I see it, is the FDA delaying approval well into next year, or if they really move slowly 2024.

I'm not saying this is what I expect, just looking at the worst possibility. The U.S. FDA is still considered the gold standard, but they also are often the slowest to move and often don't approve drugs until substantially after other regulators.

It will be interested to see what the company has to say about applying to the regulators, have they applied to all four simultaneously, or as some suspect the U.K. first.

Perhaps some here know the differences between what's submitted to the different regulators, my thought is that there should be more similarities than differences, but I don't know that to be the case. If in fact the packages that go to the four regulators are nearly identical, I would think that all four would be delivered within a matter of weeks of one another's.

On the other hand, if NWBO initially believes it can only fulfill the demands in the U.K. until it adds further capacity, perhaps only the U.K. receives the package for awhile.

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