Biotech Values

[poorgradstudent]

CRME:

>Having a high safety profile - especially the fact that no torsade de pointes has reported up to date, and the fact that IV vernakalant studies included patients who had AF recurrences on oral antiarrhythmic agents , I think that vernakalant has a high probability to be the next antiarrhythmic approved for the IV termination of recent onset AF.<

I certainly can't argue with the potential that V represents.

However, with regards to the safety profile, I do think we're getting ahead of ourselves. Until we have a clear idea of how durable the V induced rhythm is, we have little idea as to how often patients will have to be given V. If V needs to be repeatedly dosed, then the side effect profile deteriorates incrementally.

Further, it is not sufficiently clear to me at this point if V can even be dosed multiple times. In the trials, it appeared that those that don't respond to the first dose had a significantly reduced chance of responding to the second. If this type of pattern plays out for consecutive V dosing over visits, then it could hamper the drug's utility.

Just to be clear, I would not be surprised if V is approved. What I am trying to convey in my posts is that I *would* be surprised if it posts meaningful sales without additional clinical data. My view is that people's perceptions of the drug have outpaced the clinical data currently available.