2}UK MHRA has allowed DCVax to be given to patients for over four years on a 'Specials' compassionate use program, despite not yet having MAA approval. No issues in terms of either Safety or efficacy have ever been raised.
has been heavy on my mind since the revised RWE FDA guidance came out along w eagle8's (and your) reference "Merck teams up with Atropos Health to generate rapid real-world evidence insights : 15 January 2025". Ten years (a nod to Flipper) of Specials data adds up to a nice Registry of RWD that they'll be able to incorparate in their trials and applications. I'm sure it's part of the current MAA.