That would be a guess. Many years have passed since the last FDA application was made. There's a bunch of advsiory videos on Youtube on the process, and where things go wrong. Most companies don't do enough thorough testing - apparently this is the biggest problem area the FDA sees. This it is probably what happened.
Refer to 4:40 onwards in this video:
That would be a guess. Many years have passed since the last FDA...
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