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BonelessCat

02/03/14 10:51 PM

#53491 RE: ridinbulls #53481

This is exactly the kind of binary construction that to me is irrelevant to B given the Phase 2a outcomes. There are many more outcomes possible than 2 just in the conditions you set. After all, in what ways superior? Lower, single dose with higher efficacy measured by sustained tissue repair and healing? Superior with same efficacy in a single dose? Superior in a 3 day course as opposed to a 7 day course, but the same sustained efficacy?

I can go on....

Let's name 2 scenarios and get opinions on what the approval process would be...

1. B is shown to be Non- Inferior to D.

Do we see a phase III?

2. B is shown to be superior!

Do we see phase III?

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noretreat

02/04/14 7:27 AM

#53502 RE: ridinbulls #53481

It will be difficult for B to be found to be superior to D on the primary efficacy measure in this test. This is because of the way the test is evaluated. We can figure D to have 95-97% efficacy. Even 100% for B would not be statistically different.

The key for single dose B is to equal D's efficacy, and therefore beat it soundly on ease of use, compliance and cost (do we know that cost is lower?). If B equals D efficacy in this test, then there is a good chance it will become the standard of care in acute bacterial skin and skin structure infections, or ABSSSI.

We don't have that much longer to wait....less than a year.