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Complex drug products typically require additional bioequivalence studies that add 1-2 years to development timelines and $3-10 million to development costs

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Additionally, it was detected, in neurotoxic and inflammation-driven animal models of PD, an increase in CB 2 receptor expression that correlated with an increase of microglial activation ( 2 receptors in neuroinflammatory processes associated with PD

Each indication requires its own evidence base

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