emails from dr neil frazer, page-7

Correct GregNZ, but if they have proven manufacture and safety as the Phase2b trials were designed for. Then the only thing that could prevent it getting approved to Phase 3 is if it had disastrous results in the trials (Phase 2b).
ie. accelerated patient death or extreme side effects. Despite other cancer drugs and therapies being FDA approved with severe side effects, CVac is minimal if any. Neil would know of any extreme side effects in the Phase 2b trials as he is overseeing them.

How else can the Phase 2b trials fail?
Perhaps there is someway they can...however I am not aware of such.

The only thing left is to prove (IMO) is that CVac statistically has favourable outcomes over standard forms of treatment in Phase 3 trials. This was proven in Phase 1a or Phase 1b (can't remember which one)...however now needs to be proven on a larger scale.

You are right that it is a spec...to me a spec is a company that is not producing profits yet. However each speculative stock has a degree of risk. The upside is around 2000% from here and the downside is perhaps 90% at most (absolute worst case scenario including another GFC). I rate CVac as a 50/50 of going all the way, mainly due to it's non toxic nature and that it already works to some extent in small patient trials. It can still go to market without FDA approval, but just a smaller market. Even Martin has stated that CVac is not like other drugs that if they don't get approved it means they get binned. CVac could still see light and profits without FDA approval. Although FDA approval is the big one that opens up markets and brings in the $$.

Note: CVac has had better results in trials in terms of EFFICACY than Provenge and the like at the same stage of development.