Designs for the True Salvage Patient
It is our strong contention that designs that offer only one novel agent are unlikely to succeed, and may compromise future use of that agent in a combination.
While it has never been an easy task to coordinate trials with multiple pharmaceutical sponsors, our conversations with industry have been very promising
Several companies have expressed willingness to collaborate on salvage studies. But they donít want to compromise their chances of registration - ideally, they would like the data from such trials usable to support approval
It is ABSOLUTELY KEY that FDA proactively offer clear and unambiguous guidance with regard to these issues.