MSB to dispute FDA finding in Type A meeting, page-172

I think you have the Type A meeting and from there it is determined whether it is a Class 1 or Class 2 depending on the re-submission/information provided.

For instance, if the Type A meeting takes 30 days, and MSB provide information that says we are not doing a placebo on children, but approve us for children and we will then do a post-marketing study on adults, then the FDA determine whether that information means the CLR is a Class 1 or Class 2.

MSB clearly think it is a Class 1 as they said that they think they have been delayed 3-4 months. That means 30 days for Type A meeting, and then 2 months for Class 1 decision.

I think that is correct, as it matches timelines and info here....https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.110