RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Type C Meeting Timingsaccelerated BLA is not accelerated approval...
there are many routes to have a BLA approved in less time than is the normal goal date... Fast Track, Breakthrough designation, Priority Review and Accelerated Approval.
Accelerated Approval is VERY different... approval is granted on a yearly basis, it is conditional, and is determined via a Phase IV trial... Matt has confirmed that Phase III will be traditional kind... so NO AA... why do you continue to mislead.?
words are important. ONCY already has FAST TRACK designation for mBC Phase III, and a SPA in place... and they've been in place for 5 years...
Just like how ONCY changed it's slide deck to state, registration enabling trials, rather than Phase III..
They are no closer to approval than they were 5 years ago, and Bracelet-1 was a waste of time. They only had to repeat IND-213 - it would have completed by now... but perhaps Matt didn't think believe his own randomised data.... and thouight a Phase III at larger scale would fail... this management is tragic. and the pps says it all.
it's a shame you can't copy and paste some additional brain cells.