I assume that the completion of P3 trials will cover the issue of efficacy.
Clearly the Americans are offering more choice and flexibility with the Cures Act.
Anyway, instead of going to India or Russia to pay megabucks for dodgy and unproved treatments, people can express their free choice to pay for a home grown treatment and take their chances regarding how well it works.
I like to call that approach common sense.
I assume that the completion of P3 trials will cover the issue...
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