Innovation Pharmaceuticals Inc (IPIX)

[KMBJN]

Agree that was a good inference, as all trials have continuing safety analysis, so why would it refer to that?

I noticed the original plan was for two B dosing groups.

In parallel to these manufacturing efforts, the Company has drafted a study protocol toward initiating a planned Phase 2 trial of Brilacidin for COVID-19. This proposed study has two active treatment arms evaluating different IV dosing regimens in hospitalized patients with COVID-19.

http://www.ipharminc.com/press-release/2020/7/13/innovation-pharmaceuticals-clinical-trial-testing-of-brilacidin-against-sars-cov-2-covid-19-targeted-to-commence-q4-2020

So maybe FDA said you have to start low with one dose level, then add an interim safety analysis at 25% to permit increased dosing duration (from 3 to 5 days).

I'm remembering something where it was said that interim analysis results would be shared, which I assumed meant efficacy.

Oh well, just wanted to comment on all our past speculation here on this board, that it does not appear there will be any reading of results before study is over. We may not even hear of another DSMB meeting where they say essentially, "all is well, keep going" like they do so frequently.

Sure would be nice to be able to see trial protocols.

Just means we have to wait longer for results, which is fine.

Regarding how often are there interim analyses in clinical trials, I would say frequently.

https://pubmed.ncbi.nlm.nih.gov/1876782/

Most trials will involve group sequential analyses at discrete time points.

Often DSMB will be triggered at either sequential times (e.g. q. 3 months) or at enrollment levels (25%, 50%, 75%). But this is a very small and hopefully quick trial, so maybe no interim analysis for efficacy by DSMB at 50% like I assumed.