Just in case anybody ever reads here:

An item that may be of interest, and apply to future FDA approvals.

A bill titled “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (S. 2388), or the RESULT Act.” has recently been introduced in the Seanate. It would give Americans access to any drug, device, or biologic approved by scientifically advanced nations, including EU member countries, Israel, Australia, Canada, and Japan.

http://www.cruz.senate.gov/files/documents/Bills/20151211_FDA.pdf

The effects of this act would be quite significant. It could allow VRS to avoid the expensive and slow FDA approvals.

http://fee.org/anythingpeaceful/one-bill-could-massively-improve-access-to-lifesaving-drugs/?mkt_tok=3RkMMJWWfF9wsRonsqTAZKXonjHpfsX86OgqX66g38431UFwdcjKPmjr1YIGTsV0aPyQAgobGp5I5FEBS7TYRKtst6cMUw%3D%3D

I hope this bill makes it through the process.