RE:RE:RE:RE:RE:RE:RE:Accelerated Approval, surrogate endpoints, registration Perhaps to dispell ANY doubt, ONCY could have phrased registration enabling study with "Registration Enabling Phase II".
It's either always deliberately vague to draw new money in, whilst weariong rose-tinted specs... or its an oversight. I would hope they clarify potential pathways at the forcoming panel meeting.
Enough of the smoke screen Matt... Either you have data to support accelerated approval, that data is forthcoming (and therefore let us know what that is), or FDA have dismissed all proposals for an AA and insist you run a Phase III..
Just because it reads wam and cuddly, doesn't mean this is the case... bear in mind IND-213, was started 12 years ago... and we have a second Phase II in mBC... BUT ONVY management have in the past told us that they will run a regular Phase III - so NO AA on the horizon for that... big trial = big money, no partner = no trial.
let's not get too excited just yet folks.