RE:RE:FDA seeks Accelerated Approval reform in Spending BillDecember 21, 2022 - as FiercePharma reported today on th FDA's reformed accelerated approval program ...
"The “agreement” Graybosch referred to was the stipulation that a drug approved under the accelerated approval pathway using a surrogate endpoint should later provide more advanced clinical data to confirm its benefit.
In a statement when the Tecentriq withdrawal was made in November, Roche Chief Medical Officer Levi Garraway, M.D., Ph.D., said the Swiss pharma understands “the need to uphold the principles” of the accelerated approval pathway.
Because the FDA just made its requirement clear, Graybosch foresaw a “massive delay” in the number of cancer drug approvals as companies try to shift gears, review their balance sheets and adjust their regulatory timelines. [ This delay should greatly benefit ONCY's pelareorep which is "Phase 3 Ready" and complies with the FDA's new reforms for an accelerated approval, putatively giving any Big Pharma acquirer of ONCY a leg-up advantage over other companies seeking a M&A deal. ]
To Graybosch, the FDA’s not waiting until the phase 3 readout suggests the agency is willing to reward companies that follow the rules, that an accelerated approval—instead of a late full approval—is possible even if the confirmatory data are supposed to come out soon.
This means small players will either have to fold their programs—or the entire company—or find a Big Pharma partner to fund a large phase 3 before getting any approval [which is what ONCY had planned years ago with the roll-out of ONCY's clinical development program].
https://www.fiercepharma.com/pharma/2023-preview-fda-revamps-cancer-drug-approvals-and-big-pharma-willing-fall-line