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[–]CytochromeP4 4 points
Today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the active ingredients of its PPP001 drug (delta-9-tetrahydocanabinol 9.5% and cannabidiol 2.5%) for the treatment of complex regional pain syndrome (CRPS). The Orphan-Drug Designation was granted for the active moiety of the drug PPP001 and not the formulation.
Not sure how they can grant a designation for an unspecified moiety in a specified formula. Is the ratio granted and protected? Is the concentration of each granted and protected?
Lets pretend it's just the percentages. If the dose is 1g then you get 95mg THC and 25mg CDB in each dose. If I create a smoke-able 0.7g dose pellet with 13.57% THC and 3.57% CBD, I've recreated the exact same dose while getting around the protection of their drug. What is the real protection behind this drug? The protection could disappear overnight depending on how the US government decides to treat cannabis in the future. If the US government decided THC and CBD will not be regulated in the supplements market I can recreate these drugs and sell them as dietary supplements cheaper than the drug bought at the pharmacy.
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