What We Need From the Agency
Sponsors need clear, unambiguous guidelines about which sorts of novel study designs may be used in support of an NDA, perhaps even overt encouragement to seek salvage indications.
To open a discussion into incentives for research into smaller subpopulations: pediatrics, salvage, IDUs, etc
A commitment to encourage industry to do meaningful expanded access programs, especially in Salvage populations. And preferably not just scant weeks before licensure!!
Co-enrollment in expanded access programs should become common. We heartily applaud several companies, notably Abbott, for their leadership in this area.