- Before Jul 1, 2028
- If the FDA approves intismeran autogene (V940/mRNA-4157) with pembrolizumab (KEYTRUDA) for adjuvant treatment of completely resected stage IIB-IV melanoma for marketing before Jul 1, 2028, then the market resolves to Yes. 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…
- Before Jan 1, 2028
- If the FDA approves intismeran autogene (V940/mRNA-4157) with pembrolizumab (KEYTRUDA) for adjuvant treatment of completely resected stage IIB-IV melanoma for marketing before Jan 1, 2028, then the market resolves to Yes. 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…
- Before Oct 1, 2027
- If the FDA approves intismeran autogene (V940/mRNA-4157) with pembrolizumab (KEYTRUDA) for adjuvant treatment of completely resected stage IIB-IV melanoma for marketing before Oct 1, 2027, then the market resolves to Yes. 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…
- Before Jul 1, 2027
- If the FDA approves intismeran autogene (V940/mRNA-4157) with pembrolizumab (KEYTRUDA) for adjuvant treatment of completely resected stage IIB-IV melanoma for marketing before Jul 1, 2027, then the market resolves to Yes. 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…
- Before Apr 1, 2027
- If the FDA approves intismeran autogene (V940/mRNA-4157) with pembrolizumab (KEYTRUDA) for adjuvant treatment of completely resected stage IIB-IV melanoma for marketing before Apr 1, 2027, then the market resolves to Yes. 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…