InvestorsHub Logo

exwannabe

07/08/17 8:33 PM

#125065 RE: monarch6500 #125061

Just as a guess, I am thinking that UK approval is on a separate timeline from the FDA,s and IF the top line data is released before the conference and if it is sufficiently good then UK may approve before FDA. This may press FDA to give AA.


There is no UK approval for onco drugs, all such go through the EU centralized review.

The timeline for the EMA (the EU equiv of the FDA) is generally slower than the FDA.

And the FDA is very unlikely to be giving an AA when they already have OS data in hand. DCVax-L would get a full approval, or no approval.

And the timeline for AA is the same as regular approval. So why are people yapping about it.

And the FDA is not going to approve because another agency did.

Other than that, your post is spot on.