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Re: bhp1rtp post# 19565

Friday, 06/13/2014 12:22:19 PM

Friday, June 13, 2014 12:22:19 PM

Post# of 30990
Thanks for your response. Why couldn't they potentially get any of these expedited approvals by targeting inflammation in general? Keep in mind, anatabine is not being touted as a cure. Consider this from the wikipedia FDA Fast Track Development Program page:

If there are existing therapies, a fast track eligible drug must show some advantage over available treatment, such as:

Showing superior effectiveness
Avoiding serious side effects of an available treatment
Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
Decreasing a clinically significant toxicity of an available treatment
Addressing an expected public health need

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