Accelerated approval is very much a possibility.

Accelerated approval is very much a possibility. FDA OCE has been very active in utilizing the accelerated approval pathway. See for a list.

https://www.fda.gov/drugs/resources-informati...-approvals

I think this is why Dr. Jay felt mCRC was perhaps the fastest way to market. FDA does recommend early discussion if pursuing this pathway. A follow on trial would be required to verify long term benefit. This trial might need to be started prior to receiving the accelerated approval as FDA is concerned with sponsors dragging their feet.

From FDA guidance document:

"While a variety of trial designs and endpoints have historically been used to support accelerated approval, single-arm trial designs and response endpoints (with duration of response as supportive) have most commonly been used in oncology. Response rate is a marker of drug activity because malignant tumors do not typically regress on their own, and because this endpoint can be interpreted in single-arm trials for monotherapy oncology drug regimens."

Note "for combination regimens, the contribution of the individual components to the claimed effect(s) generally may be challenging to establish."