(Total Views: 422)
Posted On: 09/10/2025 8:12:18 PM
Post# of 156888

I know this happened during Covid where NP said the FDA told them to shut down Eind to help get the severe trial enrolled more quickly. Does that bring up a dilemma here as well. The issue is we have a molecule that has been proven very safe in 1600 patients that is likely effective being trialed on very sick patients. This is an unlikely situation for most drugs that are currently in trial. As a patient why would you enroll in the trial and risk getting placebo if you can get the drug guaranteed via Eind or Right to Try. Can the Eind patients maybe be counted as a separate open label arm in TNBC and CRC and future oncology trials to help with gaining approval via phase 4 in combination with the current relatively small phase 2 and the 1600 patient safety data without another larger pivotal phase 3?

