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Re: wahjjhugo post# 23522

Tuesday, 02/17/2009 10:27:31 AM

Tuesday, February 17, 2009 10:27:31 AM

Post# of 51850
Just to clarify: my comment about the challenge of running Phase III for RD was not to indicate it can't be done--it can--but to note that it was not the kind of fast/cheap process that a small company could pull off. Certainly not within Cortex's reach.

The 'safer better opiate' concept is extremely valid, particularly with the FDA requiring opiate marketers to produce new safety plans. But it won't utilize CX717, because this is a chronic use indication. It also will not be cheap or easy--but it could conceivably produce a monopoly in the opiate market, since the FDA itself has said that it might require less safe competitors to be pulled from the market if a demonstrably better alternative is produced. But not all companies would have an interest in both acute RD (hospital market) and chronic use opioid development.

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