Oncolytics Biotech Inc T.ONC

FDA seeks Accelerated Approval reform in Spending Bill

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As posted earlier today regarding the FDA's accelerated approval reforms sought in the current Congressional Spending Bill and Big Pharma's enhanced interest in ONCY's pre-emptive approach in postitioning pelarerorep for an accelerated approval....

" ONCY is ready for the FDA's recently sought reforms in the accelerated approval process that would be be codified in the new Congressional Spending Bill as a result of  ONCY's clinical trial progress and stated intent towards the filing of a registrational breast cancer study."

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Repost:  December 20, 2022 - Accelerated Approval Reforms in Congress Spending Bill "When Robert Califf, M.D., retook the helm of the FDA earlier this year, reforming the accelerated approval pathway for new drugs was one of his top priorities.   Fast forward almost a year and those reforms are close to being cemented into law after they slid through negotiations to make the

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December 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

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December 23, 2022 -  Merck’s receives FDA full aproval under an accelerated approval program for anti-PD-1 antibody blockbuster Keytruda in a less-frequent dosing regimen.  [Such a simple reason for full approval under an accelerated approval program suggests that ONCY's opportunity for accelarated approvals in both breast cancer and pancreatic cancer is much mor probable than