Hmmm.....it would be interesting to know what % of bolt-on trials are successful.

In our case, if a bolt-on is simply going to confirm what we already suspect; namely that given the appropriate powering apabetalone will achieve meeting the primary endpoint, and if the drug is safe (which is confirmed) then it makes little sense for the FDA not to approve it now.  Although DM does say it’s a longshot he also goes out of his way to make an argument for approval, especially when he says that he ‘doesn’t think we have a serious problem here’ and that he is excited to have the meeting, that we have a good relationship with the FDA, etc., etc.  So, although on the surface the meeting with the FDA may be standard practice after the conclusion of a P3 trial, I think that DM & Co. are viewing it as much more than that.

One thing for sure is that the next few weeks are shaping up to be among the most pivotal in the company’s history.