BLA approval is very likely, given the facts that it is approved on a "named patient" basis in Europe and the FDA granted "Orphan Drug status". However, you never know for sure until it is a done deal.
Check out Dendreon DNDN. They are in the same vaccine space but for prostate cancer. IIRC, about a year ago they were at 2.50 and now they trade around $35.00.
The first step is emerging from bankruptcy. That should happen by June and it may be eminent. As soon as they are out of bankruptcy re-org the stock will really move.