I did not see anywhere where it said it is FDA approved. FDA approval would usually come through the manufacturer. There is no reason the manufacturer would spend the millions needed to get approval for this protocol. The market is just too small. The protocol is 25 mgs once, maybe twice.

The primary use of etanercept is for autoimmune diseases at 50 mgs per week at a cost of $16,000 per year. That is $153 per 25 mg dose.

I doubt insurance companies will ever pay for it. It is too experimental. The cost benefit ratio is too high. If it came down to below $1000, they may change their position.

A few lawsuits against the manufacturer for bad side effects could end the program and send it off-shore.