RE:eyes on the prizeWe all know that the reults were "Brilliant" but the results were from the "Bracelet".
And surrogate endpoints do not have to be "perfect" to predict OS outcome - but the FDA has found them good enough of a predictor in multiple Phase 2 studies and will now increase importance of Phase 2 surrogate endpoints to grant accelerated approval, given that the FDA has increaingly opened its Accelerated Approval process to surrogate endpoints, with the passing of the Inflation Reduction Act (IRA).
For example : Zynyz was approved was based on Phase 2 data from the POD1UM-201 trial, a single-arm study that tested the drug in adult patients who had not received prior systemic therapy. Zynyz had an objective response rate of 52%. The duration of response in these patients ranged from 1.1 month to more than 24.9 months, with 76% responding for six months or longer and 62% responding for 12 months or longer.
https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-inc?postid=35421604
And who will pay for a Phase 3 registration study? Any Big Pharma company who is looking to add pelareorep to their immune checkpoint inhibitor in pancreatic cancer, or with their CAR-T therapy, or bispecific or ADC, or small molecule like PARP and CDK 4/6 inibitors products.
And who else will pay for a Phase 3 study involving the biological product pelareorep? Well any other Big Pharma company who is seeking to preclude the loss of market exclusivity on their core drug products that are facing loss of patent protection and a looming patent cliff.
https://stockhouse.com/companies/bullboard?symbol=t.onc&postid=35421458