May have re done clinical data. More llikely, they changed the...

May have re done clinical data.

More llikely, they changed the claims or IFU. I note the wording in the announcement stated it is to be used as adjunct for diagnosis. So not be be solely relied on. Or it could have been as simple as stating in the labelling when the results may not be reliable. There are various tricks of the trade the regulatory team may have used to get FDAs satisfaction. Nice work though they should never have let the first attempt be officially rejected. Now its in the public record. Normally you withdraw the application once you know the aren't going to clear it.