Replies to post #357303 on Innovation Pharmaceuticals Inc (IPIX)

[Rdunn88]

19 subjects used for OM interim analysis? They should have close to 30 completed now which includes the evaluation period. Makes no sense for OM and not a pandemic situation.

presented below is information on Cellceutix’s clinical trial of Brilacidin for OM, including preliminary Interim Analysis of 19 patients (9 administered Brilacidin; 10 administered placebo) who have reached or passed the planned visit at the end of 5 weeks on study, and received a cumulative radiation dose of at least 55 Gy.


http://www.ipharminc.com/new-press-release/2017/3/26/cellceutix-reports-very-encouraging-interim-analysis-of-phase-2-drug-candidate-brilacidin-for-severe-oral-mucositis-om-in-head-and-neck-cancer-patients-high-potential-for-preventative--cyml9

[Justfactsmam]

You are confirming another reason (beside double-blinded) why there was not and could not be an "Interim Efficacy Analysis" in the Brilacidin-COvid-19 Clinical Trials. Just based on the CT design requested, and planned and inserted into the Protocol of the Clinical Trial APPROVED by the FDA...

The downside of interim analyses is that they raise the hurdles for statistical significance of the final results.

It not a matter of "Downside" (which is a strawman setup)...its a matter of design...Efficacy Interim Analysis was NEVER PR'd...and would not have been simply because it was never in the protocal and could never be done based on the 3 to 5 day safety dosing and, then continuing the remaidner of the patient with a 5 day dosing protocal...

Bottom Line...there was no representation or PR that interim efficacy would ever be done...

its a Strawman setup... All referenced Efficacy is FINAL ANALYSIS... none state "Interim"