In my experience talking with biotechs I have found that this is one of the reasons, but not the primary one.
Like any r/r calculation it’s a combination of factors. Companies have to examine the potential of treating patients under these pathways on a risk/reward basis. The FDA not liking what you’re doing is one of many risks which gets weighed. Sure they won’t officially enforce against you but you don’t want the guy overseeing your trials to carry a secret grudge.
However if I were asked what is typically the most relevant risk it’s actually reputational risk/damage with investors. Investors tend not to like when their companies use EA/RTT, and of course if something goes wrong even if the FDA doesn’t come after you, one bad headline might kill your next fundraising round. For a company that needs to raise money to survive, both of these are actually pretty big deals.
In my experience talking with biotechs I have found that this is one of the reasons, but not the primary one.
Like any r/r calculation it’s a combination of factors. Companies have to examine the potential of treating patients under these pathways on a risk/reward basis. The FDA not liking what you’re doing is one of many risks which gets weighed. Sure they won’t officially enforce against you but you don’t want the guy overseeing your trials to carry a secret grudge.
However if I were asked what is typically the most relevant risk it’s actually reputational risk/damage with investors. Investors tend not to like when their companies use EA/RTT, and of course if something goes wrong even if the FDA doesn’t come after you, one bad headline might kill your next fundraising round. For a company that needs to raise money to survive, both of these are actually pretty big deals.