General discussion, page-12254

Epidiolex has FDA approval and therefore significantly cuts the regulatory pathway as you are just using 2 existing drugs that are already approved, marketed and known to Doctors but showing that the combination is superior/synergistic to treat a new indication.

Further down the line could then launch a version 2.0 and run an additional bio similar trial to swap one of the components but that would require the first combo to gain FDA new drug authorisation NDA first.

Which is why the BOD here are first class as they have a great balance of scientific and business acumen to get these drug to patients in shortest time possible.