If the FDA approves any psychedelic substance for medical use for marketing before Jan 1, 2027, then the market resolves to Yes. Psychedelic drugs include: LSD, Psilocybin, DMT, Mescaline, MDMA, MDA, PCP, DXM, Ibogaine, Salvia divinorum, 2C family, and Ayahuasca.
Important information: For purposes of this Contract:
The listed substances are illustrative, not exhaustive. Approval of any other substance commonly recognized in scientific or FDA documentation as a psychedelic, hallucinogen, or entactogen (for example, psilocin, 5-MeO-DMT, methylone, or 2C-, DOx-, or NBOMe-family compounds) may also satisfy the Payout Criterion.
"Approval for medical use" means an FDA approval letter for an NDA or BLA authorizing marketing of a drug or biologic for human medical use in the United States, where a listed (or otherwise qualifying) psychedelic substance is an active pharmaceutical ingredient of the approved product. Complete Response Letters, tentative approvals, Emergency Use Authorizations, expanded access or compassionate use authorizations, and approvals limited to export do not satisfy the Payout Criterion.
Combination products. Approval of a combination drug product satisfies the Payout Criterion only if at least one active ingredient is a listed (or otherwise qualifying) psychedelic substance and that psychedelic active ingredient has not previously been approved by the FDA via NDA or BLA for any human medical indication. By way of example, an FDA approval of AXS-05 (a combination of dextromethorphan and bupropion) for a new indication does not satisfy the Payout Criterion, because both active ingredients were FDA-approved prior to Issuance.
New indications for previously-approved substances. An FDA approval (including via supplemental NDA or supplemental BLA) of a new medical indication, dosage, or formulation for a substance whose active pharmaceutical ingredient was already approved by the FDA via NDA or BLA prior to Issuance does not satisfy the Payout Criterion.
Advisory Committee votes, sponsor withdrawals, and CRLs do not by themselves resolve the Contract. Resolution turns solely on whether a qualifying FDA approval letter is issued after Issuance and before January 1, 2027.
If the FDA approves any psychedelic substance for medical use for marketing before Jan 1, 2027, then the market resolves to Yes. Psychedelic drugs include: LSD, Psilocybin, DMT, Mescaline, MDMA, MDA, PCP, DXM, Ibogaine, Salvia divinorum, 2C family, and Ayahuasca.
Important information: For purposes of this Contract:
The listed substances are illustrative, not exhaustive. Approval of any other substance commonly recognized in scientific or FDA documentation as a psychedelic, hallucinogen, or entactogen (for example, psilocin, 5-MeO-DMT, methylone, or 2C-, DOx-, or NBOMe-family compounds) may also satisfy the Payout Criterion.
"Approval for medical use" means an FDA approval letter for an NDA or BLA authorizing marketing of a drug or biologic for human medical use in the United States, where a listed (or otherwise qualifying) psychedelic substance is an active pharmaceutical ingredient of the approved product. Complete Response Letters, tentative approvals, Emergency Use Authorizations, expanded access or compassionate use authorizations, and approvals limited to export do not satisfy the Payout Criterion.
Combination products. Approval of a combination drug product satisfies the Payout Criterion only if at least one active ingredient is a listed (or otherwise qualifying) psychedelic substance and that psychedelic active ingredient has not previously been approved by the FDA via NDA or BLA for any human medical indication. By way of example, an FDA approval of AXS-05 (a combination of dextromethorphan and bupropion) for a new indication does not satisfy the Payout Criterion, because both active ingredients were FDA-approved prior to Issuance.
New indications for previously-approved substances. An FDA approval (including via supplemental NDA or supplemental BLA) of a new medical indication, dosage, or formulation for a substance whose active pharmaceutical ingredient was already approved by the FDA via NDA or BLA prior to Issuance does not satisfy the Payout Criterion.
Advisory Committee votes, sponsor withdrawals, and CRLs do not by themselves resolve the Contract. Resolution turns solely on whether a qualifying FDA approval letter is issued after Issuance and before January 1, 2027.
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