Replies to post #75347 on Innovation Pharmaceuticals Inc (IPIX)

[biodoc]

Yes, the primary efficacy endpoint is simply lesion size decreased by >20% after 48-72 hours. However, it is critically important that the brilacidin early response compares favorably to daptomycin early response. And it does. With no rescue antibiotics administered for the study groups it's kind of a no brainer.

In a previous post I mistakenly questioned the number of patients that needed rescue- it's clearly stated in the Oct. 23 PR that no rescue antibiotics were administered.

[noretreat]

So, the primary outcome is defined by meeting a standard (lesion area has decreased by =20%) and not in comparison to any other drugs. In fact, for all outcomes, there is no comparison to Dapto or any other drug.

I believe that is incorrect. What good is it to know that a drug met the standard a certain % of the time unless that % can be compared to something? Few drugs work 100% of the time.

If, at 2 days B met the standard 90% of the time...is that good? Well, it certainly is if D met the standard 80% of the time. But it is not so good if D met the standard 100% of the time. What we know at this point, again, is that B and D met the standard a similar ("statistically comparable") % of the time at the primary endpoint of 2-3 days.

[loanranger]

"But, in the submission to the FDA the comparison becomes important in presenting non-inferiority or superiority over the current standard treatment."

Can I infer that....not addressing B but generally....the FDA would not approve a drug that is effective, but less so, than an existing drug? If that's true, and I'm a little bit afraid to ask, but do they also take price into consideration?


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[TheHound]

Correct BK. This is true w/ regard to the primary outcome measures. You've summed it up nicely in several posts now.

Thanks. App.