If by no guarantee you mean there is some chance of e.g. a meteorite falling on one's head, then there is always a chance of that happening.
Does "no guarantee" mean no facts to support approval? We have a collection of pros and cons, both of which have been widely discussed on this board. There is a definite support, majorly in Phase II results, that bavituximab is efficacious in this indication. Sure there are pitfalls on the way to approval which must be considered, but saying that there's no guarantee -- and meaning that there are no facts nor arguments support that -- is similar to saying that even a kindergarten graduate could start a clinical trial and have the same chance of it being approved.
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