“But what you write really has no practical application for ipix. Primary endpoint failure would be devastating. There’d be no second chances.”
So that IPIX’s main Secondary outcome (Duration) is what most other Rx are using as their Primary — not Incidence, like us — isn’t relevant???
Other Rx in fact are saying Duration **is good enough** to get approved and this with Regulatory input (eg SGNX Ph 3 trial design)
Your logic: Does. Not. Compute.
As to B-OM, I do expect a Reduction in Incidence (Primary) vs placebo and Reduction in Duration (Secondary)
how great the spread need be in Primary?
Anything over 10pt imo a success. Anything over 20pt imo Big Success. Anything over 30pt imo HUGE.
Again there is no approved OM treatment out there other than KEPIVANCE, with limited label, recently pulled from Europe. OM doubles cost of care and results in 20% dying prematurely from what I recall reading.
So enough w the dire language — “failure” “devastating” “no second chances”
B OM has BTD potential and the FDA and any Rx Partner will see that if Topline delivers a successful trial.
Again our Secondary - Reduction in Duration - is other Rxs Primary... on its own, RID might elicit approval regardless of RII, highest bar
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