Ann: Director Appointment, page-33

I think his line "I believe I can make a substantial contribution" says it all.

To what extent will his involvement be at the upcoming BLA resubmission, formally or informally, we may never know. But he is probably well aware of where the boundries were drawn and how the cookie is likely to crumble when the BLA resubmission is accepted and goes through the formal review stage. Having him on our bench will be invaluable in the sense that his reputation at CBER will in itself add weight to our resubmission, not to mention who now sits at the top of the FDA.

The review team at CBER will have to contend with a 9-1 ODAC vote, Robert Califf as the head of the FDA and now Dr Krause from our Board. They were well within their right to issue a CRL around concerns on manufacturing / MOA, which I see as the 'CRL we had to have'... but the reasons to hold back approval are IMO evaporating.