So, reading between the lines, the difference between the last inspection and this one, is that the FDA has now been able to deem technegas as needing to be a combination product. This makes the 'Complete Response Letter' from 2021 understandable based on the FDA not understanding exactly what Technegas was.
No more trial data was required after the last CRL, but it was more the way it was presented to the FDA.
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