Many peptides are unlikely to ever receive FDA approval because their simple, easily replicated structures make them commodities. Pharma companies won't fund billion-dollar trials for drugs they can't patent, leaving them in a permanent gray market.

While the FDA is often blamed for high trial costs, a major culprit is the consolidated Clinical Research Organization (CRO) market. These entrenched players lack incentives to adopt modern, cost-saving technologies, creating a structural bottleneck that prevents regulatory modernization from translating into cheaper and faster trials.

A significant portion of biotech's high costs stems from its "artisanal" nature, where each company develops bespoke digital workflows and data structures. This inefficiency arises because startups are often structured for acquisition after a single clinical success, not for long-term, scalable operations.

While AI can accelerate the ideation phase of drug discovery, the primary bottleneck remains the slow, expensive, and human-dependent clinical trial process. We are already "drowning in good ideas," so generating more with AI doesn't solve the fundamental constraint of testing them.

The Orphan Drug Act successfully incentivized R&D for rare diseases. A similar policy framework is needed for common, age-related diseases. Despite their massive potential markets, these indications suffer from extremely high failure rates and costs. A new incentive structure could de-risk development and align commercial goals with the enormous societal need for longevity.

Unlike software startups that can "fail fast" and pivot cheaply, a single biotech clinical program costs tens of millions. This high cost of failure means the industry values experienced founders who have learned from past mistakes, a direct contrast to Silicon Valley's youth-centric culture.

Developing an antibiotic is costly, but its use is short-term and new drugs are held in reserve, making them unprofitable. This market failure, not a lack of scientific capability, has caused pharmaceutical companies to exit the space, creating a worsening global health crisis.

A massive disconnect exists where scientific breakthroughs are accelerating, yet the biotech market is in a downturn, with many companies trading below cash. This paradox highlights structural and economic failures within the industry, rather than a lack of scientific progress. The core question is why the business is collapsing while the technology is exploding.

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