REMS certification as a transferable asset

Because Spravato can only be dispensed at certified sites under the FDA's REMS program, certification functions as a moat: a new competitor cannot simply open next door and offer the treatment. That scarcity has real value in a transaction.

But certification is only an asset if it survives the sale. Buyers will examine how the certification is held, whether it attaches to the entity or the location, and what re-enrollment would require if either changes. Sellers who can answer these questions with documentation — not recollection — remove one of the most common late-stage diligence delays.

Limneo perspective: treat your REMS documentation like a payer contract. It belongs in the data room from day one.