I don't think approval is a slam dunk at all because they are simply taking two already approved drugs and combining them. I've hear the FDA is not big on that kind of a ploy for money. They will need to show some extra efficacy of some kind for a more certain win. But it is possible they have friends in high places!
I'm not sure if I want to plant my money in this stock now which would require an 18 month wait for much movement. I'm sure there will be some normal ups and downs and newsletter pumping during that time, but I'm still thinking.
Without approval,I would be surprised to see any kind of a partnership deal or a buy out take place, but this is biotech and anything is possible.
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