The FDA's arguement in such a court case is going to sound like something Jack Thompson (the guy who was always trying to sue the video game industry and who sued Janet Reno for sexual harassment) would come up with...
"they can call Amarin's bluff and said, see you in court - which they are entitled to do."
This is not going to happen. The judge will order a cease and desist and reinstate the contract, the FDA is not claiming safety. If the FDA continues at this point things could get very very expensive for the FDA, and for what..This is being done either because someone in the division has an ego problem, or there is a big and very criminal BP behind this..
Agree a lawsuit is the last option - what we need to do ASAP is get someone on Congress to hold a hearing on this bizarre change in the FDAs view on treating TGs despite every other medical organization on earth holding totally different opinions - this is a public health issue of huge proportions if the FDAs position stands.