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Thursday, August 03, 2017 9:47:15 AM
I also found the descriptor below which perfectly aligns with all of IPCI's previous statements on completing human abuse and liability studies.
Nowhere in any previously disclosed to the public domain IPCI statements in their press releases, financials or filings did IPCI ever claim that they had in fact completed any human abuse potential (HAP) studies for oral and nasal...which is why I keep insisting that the ambulance chasing class action lawsuit threat due to the Rexista adcom rejection is as bogus as it comes.
And if the HAL studies IPCI already completed only cost them $1M to $1.5M then 1 would think the HAP studies should be around the same costs. Hopefully someone more familiar with HAL/HAP costs can weigh in cheers>>>
Human Abuse Liability (HAL) and Human Abuse Potential (HAP) clinical studies may be required by the FDA to evaluate the abuse liability or abuse potential of a New Chemical Entity (NCE) for drugs that affect the central nervous system. HAL/HAP studies provide insight to understand if the drug is “liked” as compared to a drug in the same drug class or a drug that has the same or similar mechanism.
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