Biotech Values

[AlpineBV_Miller]

Since there has been no listed approval for 3rd line I'm aware of, having the FDA say there are approved thereapies USED in 3rd line as a reson for the RTF would be a significant change in interpretation of accelerated approval rules.

I'll note Pazdur has precedent for this. His requirement that confirmatory trials be "substantially" underway prior to granting accelerated approval is nowhere in the regs. In fact, it goes against Congressional intent.