Chances are (if u look at the % of drugs that do clinical trials vs how many get FDA approval) it will fail and the cost will be in the multi-millions = debt and profit drain.
The flip side of this is the appeal for the patent fails and CVSI is denied (for real) a patent at all. That might mean that the 007 drug is put on the back burner, which would mean no clinical trials and no debt. So in a way it could work out because no debt is still a good thing.