I think many here may not appreciate how long it will take to write up the trials for licensure once the trials are complete. It's my experience that the writing phase is longer than expected, especially if there's any controversies afoot. Secondly, the FDA, besides being a scientific driven department must thrive within the larger US bureaucracy and that mean political pressures to come to bear upon those that write up results.
And then, the FDA can take as long as a year for its review. If the therapy/drug gets fast track, then the approval time might be as long as 6 months.
It is my humble suggestion that you not make bets on any pre-approval biotech company if you aren't especially patient.
In the back of my mind, I'm thinking that ACTC might be a 2013 or 2014 approval... And if that's the case, real values won't be ascribed to it until the quarter before approval "if it is likely to be approved..."
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