Yes I would.
Randomised trials establish if the product is effective. That is the way new products are tested. Obviously, this means some patients get the product and some of them get the placebo. Hardly news there. It’s been standard practice for ages and ages.
There is an argument that msb can role out the product and do the study later. I accept this. But, frankly, If 100 are treated and in is effective in, say, 5 and not effective in 95 (at $300k to $350k a pop) then I would say it is not worth the cost.
MSB to dispute FDA finding in Type A meeting, page-184
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