I wasn't saying things won't get tougher, I'm sure they will to some degree. But tnat doesn't mean safety wasn't the major concern at the fda before. I doubt there's a sudden mindset shift on squalamine. Systemic delivery has always been a major risk of the squal program. Maybe vioxx woke investors up to this.
I think we'll see much closer post approval surveillance. Perhaps a new risk for investors can be added, "post approval safety risk." Probably more contingent approvals with LT follow up requests. I don't think we'll necessarily see LT trials beyond what they already are in many indications, including AMD (2 years?).
Certain indications, probably huge trial requirements where only big rx can afford. Others will remain similar to today. Chronic use? ST use? Millions of users, or orphan indication? Serious need? Lifestyle drug? Me too?
Find the co's working on breakthrough drugs for serious unmet medical needs.
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