Being a staged, adaptive design phase 3 trial, the 2mg twice weekly will be worked into the trial and we will pass our phase3 trial with this dose, I have no doubt about it.
When the phase 3 trial was designed 008 hadn’t been completed. We now have more data to proceed here. I mean what else do they actually need now? The FDA will SURELY allow the stage 2 component of our pivotal trial to have our best dose in it!!!
Donna (and Paul) have made it very clear 2mg twice weekly is our preferred dose. And we have the data to back it up.
I guess, if the FDA want to be onerous, it’s whether that means stage 2 has three arms to it. 1.5mg twice weekly, 2mg twice weekly and placebo. Potentially the dataset produced in 005 and 008 (2x phase2b) is enough to satisfy the agency that we have a minimum effective dose with 12 month duration that is clearly safe.
Either way, Stage 1 is over (Putting historical data on lesser dosages in its place) and our Stage 2 can be adapted.
Our numbers to date suggest we kick placebos butt. Oh and that we clearly are DMOAD with subQ delivery too.
AGM 2024 - QUESTIONS, page-54
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