If you want a look at what can go wrong with not planning trails properly, head over to the MSB thread. They have a good product, but they can't plan a trail. FDA won't approve a crap trail, which means they can't go to market.
Then there are the different pillars, each with their own risk. I think Pillar (P) 3 is the least risky because there's already trails showing that it works. P1 and P2 hold more risk, and need more proof that they'll work. Mason and Dr T do a good job showing there's a lot of potential for P1 and P2 to work, but we won't know fully until the trails are done.
Cheers,
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