There is no such suggestion or implication from any official source. It is a new kind of product in that it is personalized at two different junctions and takes personalization far beyond any other current treatment. And it’s a biologic in that context. There were indications from the regulator that they early on were dealing first with basic post pandemic staffing issues but also that this was a novel kind of application and they likely did not have the full capacities on staff to review it completely, as I recall.
But the licensing of the facility prior to even the application being made suggests your point is false. No regulator makes a treatment that is “in trouble”, available for purchase by citizens of its country, at full prices, while simultaneously thinking, “Oh no! This is a disaster in the making!” No country licenses its manufacturing and re-licenses and then upgrades the licensing.
That would be utter nonsense.
No national drug regulator would be so scatterbrained and intellectually so incompetent as you suggest, while simultaneously thinking, this is a bad application….
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