Acceptance of NDA is a key risk reduction: The acceptance of the NDA for ibrutinib was the high probability outcome
following the filing in late June. However, there had been a risk that FDA could have issued a Refuse to File letter. This risk
was heightened by the broader than anticipated filing for CLL and the simultaneous unexpected departure of PCYC's CMO.
We had assumed that if FDA had any major issues with the filing they would use the Refuse to File option rather than deny
the drug on review
We believe approval is highly likely, and could come ahead of the PDUFA date.