This is what Amarex does, and our bus. rep. there, claims to have represented a 100 companies to the FDA. Here's what his Linkedin bio says he does:

FDA Regulatory & Clinical Trial Services + Clinical Product Development + Product Marketing Approval + IND/IDE Strategies + Clinical CRO

"Do you have a new drug, device, or diagnostic in need of an FDA approval strategy?

Are you planning a clinical trial and need a protocol designed for success….enrollment, optimal endpoints, proper data analysis?

Do you have an ongoing trial that is lagging and in need of a boost?

Do you have results of a failed trial that need exploratory analysis?

I might be able to help!

My name is Patrick,

I have 17 years of experience helping clinical product developers efficiently advance their new or repurposed products to marketing approval."

So how could Amarex not know how to file to the FDA, totally mind boggling!