Ann: FDA Confirms Approach to Sofdra NDA Resubmission, page-69

1. FDA does mention human factors in the Complete Response Letter. It is an expectation that it will be completed following the packaging and instruction amendments to ensure those changes are understood by the study group. Resubmission won't be considered without it.
2. Class 2 includes things other than listed in Class 1 - such as the HF Study. Call me silly, but I'm guessing that is why the EXPERT FDA LAWYER says it is a Class 2 Resubmission. Perhaps he is wrong - 20 years of dealing with FDA cases might do that to you I guess.
3. The rush to get the resubmission in over Xmas is because the clock is ticking! The 6 months STARTS at the moment of resubmission.
4. We'll be lucky if we get approval anything before July - fingers crossed. The FDA could just surprise with June '24, but unlikely (or so says the expert FDA lawyer anyway).