“we're expecting the initial decision from the ITC by August 21 and then a final decision from the judges by, December 21 on whether, ultimately, they can enjoin, Ascendis because they're importing the drug.”
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ITC issues initial decision by August 21, 2026 and final decision by December 21, 2026 on patent infringement case
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.
Jake Beecroft predicts that achieving an Australia-like accelerated first-in-human trial system in the US will require an act of Congress.
Cullinan's lung cancer drug has a February PDUFA date for second-line indication following positive first-line phase three data.
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.
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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