Page 351 - Binder2

Ambiguity as a Shield

Regulatory uncertainty allows incumbents to maintain a
plausible excuse for inaction:

“We’re watching the space, but we need clearer FDA
guidance.”
“We can’t proceed until there’s a validated regulatory
pathway.”
“We support innovation, but the risk of non-approval is too
high right now.”

These statements sound responsible—even forward-
thinking. But in reality, they’re a form of strategic stalling.

Because while regulators take years to adapt, pharma can:

● Continue to market high-cost injectable biologics
unchallenged.
● Avoid head-to-head comparisons with edible
alternatives that might outperform them in cost,
stability, or durability.
● Delay investment in a technology that threatens
their existing franchises.
● Let startups absorb the regulatory risk—then
consider acquiring them only after the hard work is
done.

In this context, regulatory ambiguity isn’t a hurdle—it’s a
convenient smoke screen behind which the status quo can
persist.

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