Quote:

---

They then have the possibility of stopping the trial where not further test is necessary (stop for efficacy). When this happens they, or a Clinical Endpoint Committee (CEC) will evaluate a p-number in statistical support for the termination of the trial, and/or modification of the rial to de-risk part of the patients (for example, administer Leronlimab to the patients still being treated with placebo immediately).

---

Thanks for this description.

One comment and one question:

Comment:
It would seem to me that in our binary S/C trial, a "modification of the (t)rial to de-risk part of the patients" is the functional equivalent of an admission that the trial needs to be terminated due to overwhelming benefit.

Question:
Does a termination due to overwhelming benefit always lead to some form of FDA approval? Or stated differently, if our S/C is terminated due to overwhelming benefit, is there any way the FDA will not issue at least an EUA?