From taking a quick look at the mipomersin results, the key issues are the 25% reduction (phase II was something like 40% reduction above and beyond statins) and of course the one phrase of "death" elevated liver enzymes. In one patient that is.
The 25% is on an ITT, and not on those who followed through with treatment. The drug works in a systematic matter and it reduces LDL over the course of time. I think the FDA can easily see through this. The complaint is that 25% reduction is not enough. 40% is enough. I think the data of completers will speak for itself. This is not the case, say with Elan's Bap where the completer analysis may be suspect. The completer analysis is quite relevant to this study.
The elevated enzyme in one patient does not appear to be a big deal to me.
This said, if ISIS's share price gets clobbered over this it may very well be a good looking share to get back into.
Tinker