May. 5 at 3:39 AM
$LRMR The high burn isn't about the current trial size; it is about the massive transition from a clinical-stage biotech to a commercial-scale pharma. In Q4 2025 and Q1 2026, R&D spiked primarily due to manufacturing scale and Process Performance Qualification (FDA requirement PPQ). The FDA requires proof that nomlab. can be produced at a global commercial scale, not just for lab purposes. They need a process for storing and shipping a drug with stringent handling requirements.
They need to be ready to meet demand in January 2027. They are likely already pre-building inventory for a 2027 launch, and the P3 is a global confirmatory study. Costs are rising because they are hiring the sales structure (not hiring sales individuals yet, but leadership, maybe some salespeople soon), and market access teams need to be ready to work with insurers when approved. They are gearing up as a pharma with manufacturing, distribution, sales, etc… It’s required as part of the BLA.
