“in order for that to, you know, for us to get to a full Australia like system, the a track system that they use for accelerated first in human, trials and direct IRB submissions. It's gonna require an act of congress”
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Whether Congress passes legislation enabling an Australia-style A-track system for accelerated first-in-human trials and direct IRB submissions
Yaron Werber predicts Ascendis will have until March 2027 to convert patients if they lose the ITC patent case, with initial decision expected August 21, 2026.
Yaron Werber predicts BioNTech will report phase three stage 2 data for CTLA-4 in second-line squamous lung cancer showing survival benefit vs. docetaxel.
Cullinan's lung cancer drug has a February PDUFA date for second-line indication following positive first-line phase three data.
Yaron Werber predicts ITC will issue initial decision on BioMarin vs. Ascendis patent case by August 21, 2026, with final decision by December 21, 2026.
Takeda's polycythemia vera drug (in collaboration with Protagonist) has a third quarter PDUFA date.
John predicts Coursera will run two studies (biomarker and outcomes-based) for their PCSK9/angiotensinogen siRNA program
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