I doubt if anything has been leaked. I'm confident that they will approve, but I do not think it's a slam dunk. The FDA shot it down and I'm sure this is being looked at closely by the EMEA. Maybe it's good that Amuvatinib was canceled. We don't want bad news after good news, that seems to put the brakes on. This will mean a decrease in expenses for the 4th quarter.
Free, nothing is a slam dunk but really think that Man#$2 and company think this will be approved. Went back over the Stifel Nicolaus presentation from a few weeks ago and he said "if approved, as we anticipate". Also under 2012 milesones and events, for Q3 they state "Dacogen-European Commission approval in AML expected". Tried to copy and paste below:
SGI-110 AML/MDS Phase I completed and Phase II initiated
AT13387 – Phase I completed
Data presentations at AACR, ASCO and EASL
FGFR inhibitor (Janssen) - Phase I trial started (£3.5M milestone)
CHMP opinion issued for Dacogen in AML
•Dacogen – European Commission approval in AML expected
•AT13387 – Initiate additional Phase II solid tumor trials
•SGI-110 – Data update from Phase 1/2 in AML/MDS at ASH
•SGI-110 – Initiate Phase II solid tumor trials
•AT13387 – Preliminary Phase II data in GIST
•Amuvatinib – Phase II data in SCLC
Also, interesting comments on GSK relationship. He said ASTX was ready for a "additional relationship and further collaboration" with GSK. Said Astex has a "basket" of drugs they are working with GSK on.