Very interesting I have been amazed that there hasn't been any revenue from this. My understanding is that Australia has very similar rules yet we see no evidence of income. I considered why this might be and concluded that unless doctor's were totally sure that a treatment worked they would be very hesitant to recommend it. Then you have a real problem of a company making money from a treatment thats not registered. Why register when you selling it? I assumed that through this access pathway the company supplying the product would not be able to profit possible not even recover costs.
FDA DISCUSSION, page-15
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