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Thursday, June 24, 2021 5:38:58 PM
Secondly, I’d ask who would enforce this so-called, as isn't it really more like an FDA guideline? So would there be an FDA police that comes-a-knocking the day after the year passes? And since it’s only an FDA rule/guideline, how do the other regulatory agencies (as there are three others) approach and police this rule?
And I'd add that there is also an SEC rule that companies hold their ASM 13 months after the previous one. And yet, that rule has been broken at least twice by Northwest, in recent years. And there have been no issues that have arisen resulting from not following this guideline, because no one is enforcing this type of thing, especially during a world-wide pandemic.
Finally, I think that rather than pursuing this track that when the trial was officially completed (according to who?), the data set must be presented within one year of that date… and perhaps we should instead look to what the company has been focused on this past year, which is manufacturing, and more specifically, obtaining their UK MHRA certification, and how long should that process take?
I’d suggest that the company is CURRENTLY pursuing two parallel tracks: that of "data presentation" and "manufacturing certification". Since those two things seem to be what the company is focused on, maybe in examining the timelines of the MHRA certification, there might provide a clue as to when we’ll next get our update(s).
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