I don't think the ethical approval process will be as onerous as you think. As WP has said, not a drug, is a device, much simpler path, our medical advisory board will likely also be on ethical boards (or not too far removed from them), there is plenty of 'in human' data already. The real ethical question is, as this product is clearly superior to every other product, the ethical problem of holding up its release to market... with every day hundreds of people are getting an inferior product put inside them that will need to be replaced in 5 to 10 years... load up people, this is our year. FDA approval of the pivotal study will be the catalyst for SP appreciation.
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