Ae37/Keytruda is a new trial. The one you note has the “Primary Outcome Measures :Overall Survival (OS) [ Time Frame: Up to 37 months ]”
We don’t know the protocol of the new pending combo study, but a previously filed 8k by Gnbt states:
“Antigen Express agrees to pay NSABP an amount not to exceed $2,118,461 as set forth in this Appendix B to perform the work under the terms of this Agreement. Such payments assumes (a) an actual enrollment of twenty-nine (29) evaluable patients, (b) five (5) sites, (c) twelve (12) months accrual, (d) six (6) months average treatment, and (d) at least one (1) patient receives treatment for 24 months.
Antigen Express will make payments to NSABP in the increments and at the times indicated on the Payment Schedule in this Appendix B. Payments to NSABP shall be made in four phases as follows – Start-Up Activities, Accrual and Treatment Period, Follow-Up Period and Primary Endpoint. Antigen Express shall pay NSABP invoices not later than thirty (30) days after receipt of an invoice.
3. Start-Up Activities – $340,000 – Within thirty days after receipt of a fully executed Agreement, Antigen Express will make an initial payment (“Initial Payment”) to NSABP in the amount of $340,000. The Initial Payment shall become nonrefundable upon execution of this Agreement to the extent it has been expended for costs actually reasonably incurred or committed pursuant to this Agreement. The Initial Payment supports: pre-study activities, site start-up costs, drug distributor, central lab, and database start-up costs, and other initiation and administration functions, and protocol education and awareness building.
4. Accrual and Treatment Period – $1,458,461 – Antigen Express will pay NSABP $1,458,461 during the Accrual and Treatment Period commencing with the enrollment of the first (1) Subject randomized to FB-14 and in increments as indicated on the Payment Schedule contained in this Appendix B. These payments support the costs of regulatory, administrative, and other services as anticipated in the performance of FB-14. In addition, payments include support for activities performed and costs incurred at Participating Sites, such as: patient screening, eligibility assessment and recruitment activities, patient instruction, incidental supplies and materials, tissue acquisition and storage, other unfunded costs related to the study, and the cost of patient care procedures that are considered non-routine care.
5. Follow-Up Period - $240,000 – Antigen Express shall pay an amount up to $240,000 in three (3) annual payments of $80,000 each. Invoices for annual payments will be submitted at the beginning of the calendar years for which the payments are related.
6. Primary Endpoint - $80,000 – Antigen Express will make a final payment of $80,000 upon completion of the primary endpoint analysis and submission of the primary endpoint manuscript to Antigen Express.”
https://www.sec.gov/Archives/edgar/data/10597...ex10_1.htm
We don’t know the protocol of the new pending combo study, but a previously filed 8k by Gnbt states:
“Antigen Express agrees to pay NSABP an amount not to exceed $2,118,461 as set forth in this Appendix B to perform the work under the terms of this Agreement. Such payments assumes (a) an actual enrollment of twenty-nine (29) evaluable patients, (b) five (5) sites, (c) twelve (12) months accrual, (d) six (6) months average treatment, and (d) at least one (1) patient receives treatment for 24 months.
Antigen Express will make payments to NSABP in the increments and at the times indicated on the Payment Schedule in this Appendix B. Payments to NSABP shall be made in four phases as follows – Start-Up Activities, Accrual and Treatment Period, Follow-Up Period and Primary Endpoint. Antigen Express shall pay NSABP invoices not later than thirty (30) days after receipt of an invoice.
3. Start-Up Activities – $340,000 – Within thirty days after receipt of a fully executed Agreement, Antigen Express will make an initial payment (“Initial Payment”) to NSABP in the amount of $340,000. The Initial Payment shall become nonrefundable upon execution of this Agreement to the extent it has been expended for costs actually reasonably incurred or committed pursuant to this Agreement. The Initial Payment supports: pre-study activities, site start-up costs, drug distributor, central lab, and database start-up costs, and other initiation and administration functions, and protocol education and awareness building.
4. Accrual and Treatment Period – $1,458,461 – Antigen Express will pay NSABP $1,458,461 during the Accrual and Treatment Period commencing with the enrollment of the first (1) Subject randomized to FB-14 and in increments as indicated on the Payment Schedule contained in this Appendix B. These payments support the costs of regulatory, administrative, and other services as anticipated in the performance of FB-14. In addition, payments include support for activities performed and costs incurred at Participating Sites, such as: patient screening, eligibility assessment and recruitment activities, patient instruction, incidental supplies and materials, tissue acquisition and storage, other unfunded costs related to the study, and the cost of patient care procedures that are considered non-routine care.
5. Follow-Up Period - $240,000 – Antigen Express shall pay an amount up to $240,000 in three (3) annual payments of $80,000 each. Invoices for annual payments will be submitted at the beginning of the calendar years for which the payments are related.
6. Primary Endpoint - $80,000 – Antigen Express will make a final payment of $80,000 upon completion of the primary endpoint analysis and submission of the primary endpoint manuscript to Antigen Express.”
https://www.sec.gov/Archives/edgar/data/10597...ex10_1.htm
