RE: NFX FDA update12 Jan 2026 16:56
Infor1p, how do you know the company didn't submit the info they used to answer the EMA? They might have submitted the query from the EMA and their response which then the FDA could have asked for further info based on that.
"We will respond to FDA using the data we already have on file, having previously had a similar query from the EMA."
The key word is 'similar'... the FDA is not asking the same question as EMA, they are asking a question that is similar and the company has the data to provide a response.