I think the big questions FDA want answered are:
1. Is the trial stock the same as the inventory? Prove it
2. Is there consistency in the product such that you can those who have good results do so because they are somewhat more receptive to the treatment as opposed to them just getting 'more of the good stuff' due to the product not being uniform. Prove it
Consistent and uniform.
Prove that, and they approve the product.
Because the results across multiple categories of treatment indicate that it works, and the FDA do not disagree.
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