>FGEN call
I don't know if this was a tell or not, but I was struck by their language surrounding questions about any interim looks at their anemia data. They are clearly excited by the incident dialysis trials in particular.
By way of background, incident dialysis patients have very high mortality (one year mortality exceeds 25% and was up over 30% until recently). A chunk of these patients are hypo-responders to epo and need very high doses, which is typically associated with increased mortality (which might just reflect their underlying condition of course). Historically epo trials never even included these patients at all. So given the likely safety and efficacy advantages of their drug over epo, I could imagine the differences in these incident trials might prove dramatic - enough even for some sort of an early halt.
So on questions about interim looks ("whether there are internal analysis on efficacy or safety that either are visible or not visible to us?') they clearly were very cautious in answering - there was even a warning from Neff to the person answering the question "I will ask Dr. Peony Yu if she can answer that. If you can't, you should just say that." The response was basically a hedge - we have to discuss with partners and regulatory agency, but clearly there was no denial that they were contemplating some sort of interim look.
One final clue, perhaps, was Dr. Yu's characterization of the recent DSMB look at the data:
DSMB said “continue trial as fast as we can” and later said “recommend timely execution.”
Those are pretty unusual words in my experience - normally you just get a recommendation to continue trial.
So was this all a tell or not?
Peter
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