Friday, April 22, 2022 12:51:21 PM
Most companies do not PR datalock. Data cutoff occurs prior to data lock and is what is generally more available.
These are the last 3 novel oncology drugs to be approved by the FDA.
Drug Data Cut TLD PR PR BLA acc. Conf/Jou FDA App.
KIMMTRAK 10/13/2020 11/23/2020 08/24/2021 09/23/2021 01/26/2022
OPDUALAG 01/25/2021 03/25/2021 09/20/2021 ASCO-2021 03/18/2022
PLUVICTO 01/27/2021 03/23/2021 09/28/2021 ASCO-2021 3/23/2022
None of these took over 2 months to PR TLD
None of these took 12 months for peer-reviewed data.
None took more than 14 months for FDA approval
NWBO is at 22 months post data-cutoff and crickets on all items.
The concept being posted that this timeline is normal (or even normal in Covid times) is BS. Nobody can find even one case of a drug that was later approved taking this long to get TLD out in some way.
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