hi Joe Basically the FDA now wants to see phase 3/confirmatory...

hi Joe

Basically the FDA now wants to see phase 3/confirmatory trials to be underway before granting accelerated approval. They said there's no "one size fits all approach" - and if the drug is a breakthrough drug (and we can assume that's the case with NSCLC and HNSCC given their fast track designation) then the FDA can "be flexible" in granting approval for "real breakthrough therapies" before the completion of phase 3.

AIPAC might be more of an unknown - but you'd think that they could seek accelerated approval for the known sub-categories where it has made a difference (also in the half yearly report note the comment the phase 3 component of AIPAC-003 will commence only "following regulatory interactions").

What's also encouraging is that IMM have said that they are regularly engaging the FDA and EMA in regard to trial designs. The FDA said it encourages companies to engage early so they know if drugs fall into the breakthrough categories which would allow accelerated approval.