There is an ongoing phase III study for lomitapide listed on clinicaltrials.gov that shows the FDA Office of Orphan Drug Development listed as a collaborator. It looks like Aegerion has been working very closely with the FDA on this for a long time. The FDA has already approved lomiapide for compassionate use so they must not be as concerned about lomitapide as they are with mipomersen. Provided that nothing unexpected crops up I'd say they should eventually get approval (if they don't run out of money first).
Really Archie, does it make sense that FDA is like almost playing favorites. ISIS is shaking in their boots about whether they have enough data, and good data for the FDA, and Dr. Beer is saying that the FDA is going to let AEGR get by with about 40 times less patients and that FDA even told AEGR that they could simplify their trials. 29 patients in a single armed study, I've never seen that before. It's almost like Dr. Beer's brother-in-law works for the FDA. Would you as an investor looking at this not even have the least bit of trepidation about what was going to transpire? t
I can't see how any real scientist would put any validity in a single armed, non-double blinded, placebo controlled phase III study. A one product company that uses an old small molecule drug that calls themselves a "biotech." Time will tell. t
Jetman - You were very busy this weekend over at Isis. I couldn't even follow the thread since it was so long.
I think this drug has as good a chance a mipomersen but I have my doubts that the market is as big as these Aegerion and Isis are making it.
Another thing, I saw a Texas TV station that had a story promoting a "new" technique of LDL apheresis. I doubt the apheresis companies are going to let their cash cow lose market share to either Aegerion or Isis without a fight.