NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Thanks again Koman. You wrote this in May of 2015, long before Dr. Liau's October presentation.

Hey Flipper, this quote is for you in regards to your concern about what happens at the IA for the dcvaxL pIII trial if there is a halt for efficacy but the trial may continue and what happens to the blind etc that you posted a short time ago where I told you it shouldn't be a concern- at least to me. Remember?

"The phase III study will enroll 2,500 patients with NASH and liver fibrosis. The patients will be treated with either a low and high dose of OCA or a placebo. After 72 weeks of treatment, an interim analysis on 1,400 patients will be performed on co-primary endpoints: first, a decrease in liver fibrosis by at least one stage; and second, resolution of NASH with no worsening of fibrosis.

The efficacy endpoints to be used in the phase III study are similar to those used in Intercept's successful phase II study. In that older study, OCA demonstrated a statistically significant reduction in liver fibrosis compared to placebo. OCA also improved NASH resolution compared to placebo, but the benefit was not statistically significant.

Intercept is not being asked to conduct a cardiovascular outcomes study of OCA, alleviating a concern raised by investors.

If the interim analysis is successful, Intercept will be able to seek accelerated approval in Europe and the U.S. The company, however, will continue to follow patients in the study on a blinded basis until a pre-specified number of liver-related clinical events, including progression to cirrhosis, occur. The phase III study is expected to begin enrolling patients in the third quarter."


I don't know if DCVAXL has something like this predesigned into their pIII trial but that is how I see it being played out IF an interim analysis shows meeting of a prespecified data point that would allow AA until the rest of the trial when finished confirms or not the OS advantage. I don't think LP ever mentioned anything like this, though.

In other words, under that design, Dr. Liau's October speech might be interpreted more your way, and it would explain our timeline flip flop with each other. Maybe. That language in red above reminds me very much of the language she slightly struggled with regarding "predetermined number of events."