WL you don?t appear un-intelligent, and you have mentioned it in an around-about-way in your own posts - but have not acknowledged it - or at least thought outside the box. WAY TOO FOCUSED on FDA. It is not - the only authority approval path to commercialised products [hence returns] for this Technology.
Hint: The poultice is in application in many fields. Leave it up to you to get the bulb above your head lit up.
PS: With FDA, Delivery change may affect rate and efficiency in absorption, which will in many cases lead to dosage changes - but they are able to piggyback off the existing proprietary safety and efficacy data.
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