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Re: loanranger post# 75252

Saturday, 10/25/2014 12:17:19 PM

Saturday, October 25, 2014 12:17:19 PM

Post# of 405172
loanranger, it is important to see that there is an early clinical response to treatment, regardless of the antibiotic regimen. That is, any effective treatment should be working in the first couple of days.

FDA has published a guidance paper that talks about primary and secondary endpoints for ABSSSI trials (see bottom of page 6):

http://www.fda.gov/downloads/Drugs/.../Guidances/ucm071185.pdf

Note that the secondary endpoint is complete resolution after 7-14 days.
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