Biotech Values

[ghmm]

IPF - FVC as an acceptable endpoint:

Intermune didn't directly say so but I think it was pretty much implied when they were delaying in starting the CAPACITY studies. They had talked about getting an SPA and then proceeded to start the Phase 3 despite not getting it. I remember Dan Welch saying something to the effect of disagrement between the understanding of the disease. He worded it as the company's understanding of IPF was more advanced then the agency. I didn't buy it at the time but give them credit in the end the FDA did accept it. Also at the ADCOM one of the things the agency asked the panel to vote on was meaningfulness of 10% FVC decline.