Even though it is a safety trial it has the unique attribute off...

Even though it is a safety trial it has the unique attribute off being an efficacy trial. According to PF Cohort 4 has to justify going to Cohort 5. That means not just safety but efficacy is required to complete the trial. I doubt the trial however could be be stopped if any particular Cohort produces efficacy because of the lag in monitoring. The FDA will want everything by the book.

It is interesting that PF said he got some significant flak from US pharmas/holders re their previous reporting regime and now he is gone.