Re: BiovaxID, ABPI and Accentia
I'm not clear what your point is, but there are huge problems with this crowd.
First, the PR is claiming the endpoint was in vaccinated patients, not the ITT group. This is more than just a statistical purity issue, there is a real problem. The trial was not able to make the vaccine for all patients (and not able to be on time). This could easily have biased the results.
In the ITT population the trial did not do to well. You might also note the original N.
Second, they claim stat sig at some point in time, while the trial has been unblinded for quite a while. Hell, why take 2 shots on goal when you can go on forever.
Third, the trial was stopped early for no clear reason. There was a member of the DSMB who was clearly a pal of Biovest (or if not, should have sued the company). The reason the trial was stopped was obviously cash.
Two next generation version of this drug have already failed trials.
