The CF33, Vaxinia and Oncarlytics Deal, page-1062

Hey Gossy!

Yes - a very interesting note that you highlighted there.

The FDA will require IMU to specify specific applications, and Biliary Cancer is an obvious first choice because they have good initial results there, and it has no other effective treatments. The beauty of the MAST trial is that they have invited enrolment from patients with any solid cancer type - and that means they will start to get "signals" of effectiveness across a range of cancers. I note that the PR was in Melanoma, for example.

Biliary cancer is just "first cab off the rank." They will 100% be planning to add to this - one cancer type at a time. That 's how Keytruda has become - over time - such a blockbuster drug.

If/when they get registrational approval in a single application/cancer type, and CF33 hits the market, I think there will be Oncologists lining up to recommend "off label" use against other Cancer types where initial signals of effectiveness are seen. And that could well turn out to be "most solid cancer types." Not necessarily as first line of treatment - but definitely for people who have progressive disease with current standards of care.

One application approval will open the flood gates.

Cheers

Dave