@Bendunstan You are welcome to explain why the FDA approved...

@Bendunstan

You are welcome to explain why the FDA approved Sac-T before the first-in-human study completion date.

Everyone knows study completion dates on clinicaltrials.gov are ballooned out in case of extraordinary overall survival.

You've made statements that the efficacy of a drug can't be evaluated until the study completion date specified on clinicaltrials.gov. This is categorically false, evidenced by the publication of results and, in some cases, full regulatory approval occurring years before the referenced study completion date.

Here are another two examples of oncology products that reached approval from Phase 1 years before the study completion date.

Zongertinib received FDA accelerated approval in 2025 from a Phase 1 trial, 3 years before the study completion date.




Keytruda received accelerated approval in 2014 from a Phase 1 trial, 4 years before the study completion date.




All of these investigational trials share a common theme; that they are open label in nature. Open label trials are advantageous as efficacy endpoints are evaluated at all timepoints along the trial, which enabled organisation like Merck to fast-track the development of Keytruda.

Who in their right mind would spend months stating RAC won't determine efficacy until 2029?