RE:RE:A couple of "stupid" questionsRjM2018 wrote: P3 further reduces risk. Although we showed statistically signifcant effiacy and safety with 250mg & 200mg doses, the 150mg dose wasn't powered for statistical significance. There was a very clear signal that the 150mg dose could be stat. sig. efficacious. Phase 3 trial is an adaptive design, in that they will study lower doses (like, 200mg, 150mg, 125/100mg) to find the lowest effective dose for go-to-market over 6 weeks vs 2 weeks for phase 2b.
Risks is that because the duration of treatment is 3x longer, AEs could arise...
Agreed RJM.
We have both positives and negatives at play.
To your point, duration is longer and new to OTENA ... so we don't know what to expect there.
But ...
We also have some work going on right now to better pinpoint where the drug might fail.
If we can get it down to 125 or even 100, that will play in our favour - with less active ingredient at only once per day, then we have reduced adverse effects.
Extended trial period could also be a positive thing w.r.t. H2S as we might see beyond its protective nature and into its ability to repair.
That's where the excitement comes in for the future of H2S drugs. Repair would show potential when combined with other drugs like an Alzheimer's drugs (for example) - not just protection but all out self-repair. Fingers crossed.