RE: Trial Design28 Jan 2023 00:35
Interesting. I can see why pushing to, or at least towards, MTD would be important in terms of para one: if, for example, 200mg/m² was deemed safe to be used, there's not enough data to say that it would be safe and efficacious for everyone or that AVA6000 can't be even more efficacious whilst still being safe, so push the dose level up and then choose a dose below MTD. That does sound rather old skool FDA, but if side effects are minimal and cardiotoxicity absent, then go for the highest possible efficacy!