An approval is defined as:

• For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
• For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
• For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
• For biosimilars: FDA approval of a 351(k) application

The following constitute approvals that trigger the Payout Criterion:

• Standard approval (traditional approval based on clinical benefit)
• Accelerated approval (based on surrogate endpoints)
• Approval with Risk Evaluation and Mitigation Strategy (REMS)
• Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs

The following do NOT constitute approvals:

• Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
• Approvable letters that require additional actions before approval
• Tentative approvals pending patent or exclusivity expiration
• FDA requests for additional information or studies
• Extension of Prescription Drug User Fee Amendments dates
• Approval for compassionate use or expanded access programs only
• Emergency Use Authorization (EUA) without full approval
• Approval only for export or for use outside the United States

If the FDA issues a Complete Response Letter before Jan 1, 2027, the market will resolve to No unless the FDA subsequently approves midomafetamine / MDMA for PTSD after addressing the CRL concerns and before Jan 1, 2027.

If the FDA convenes an Advisory Committee that votes against approval but the FDA approves midomafetamine / MDMA for PTSD anyway before Jan 1, 2027, the market will resolve to Yes.

If midomafetamine / MDMA for PTSD receives accelerated approval that is later withdrawn before Jan 1, 2027, the market will resolve based on whether the initial accelerated approval occurred after Issuance (Yes), regardless of the subsequent withdrawal.

If the drug sponsor withdraws the application before FDA action and before Jan 1, 2027, the market will resolve to No immediately.