News Focus
News Focus
icon url

biodoc

10/26/14 11:08 AM

#75392 RE: BonelessCat #75390

Yes. Let me try again.

(1) Was the lesion reduced by >20% at 48-72 hours? Yes/No
(2) What percentage of patients from each arm had their lesions reduced by >20%? (responders/total in arm)
(3) How does each Brilacidin arm statistically compare to the control arm (daptomycin)?

icon url

noretreat

10/26/14 11:58 AM

#75403 RE: BonelessCat #75390

As a general rule I enjoy ambiguity. In this case I find it annoying because because I have seven figures riding on it.

But I digress.

At the risk of murdering a fine point, something generally best left to others...the primary endpoint definition is ambiguous at best.

If it means that EVERY PATIENT must show 20%+ lesion reduction in under 3 days, then I am surprised any drug would ever meet that tough of a standard. Yet this is the literal interpretation of the protocol.

If it means that THE AVERAGE lesion reduction must be 20%+, then it leaves way too much room for wiggling. For example, one way to achieve average lesion reduction of 20% is for 20% of the patients to show 100% reduction and 80% to show nothing at all.

--------------------------------

One other point...No patients required "rescue" treatment. That in itself in a very significant outcome.