Biotech Values

[genisi]

By prior agreement with the FDA, the study reported here is the only phase-3 trial GILD needs to support FDA approval of Elviegravir. (Why only one phase-3 study? I’ll make the answer a quiz.)

Originally there was a second tween trial i.e. pivotal non-inferiority evaluating elvitegravir vs raltegravir in treatment experienced patients enrolling patients from EU, Canada and Australia. The FDA agreed to combine them into one global trial and cut the patients number "Due to declining numbers of patients with unsuppressed viremia". See here:

http://clinicaltrials.gov/ct2/show/NCT00707733