Outlander, Yes that is exactly my point. Combining results from the three trail when dealing with the FDA . Obtaining more Fast Track Designations and perhaps Breakthrough therapy. If this approach works as the 3 trials progress they might throw up several cancers that could benefit. IMU will then effectively from Phase 1 trials to Registrational trials. Maybe several. IMU already has two cancers jockeying for registration trials. That’s if the two short confirmation trials are a success. These two trials need 20 pax each to get registration. Probably less than that with a few already dosed.
Imagine the position IMU will be in if they get 4 or even 5 cancers set up in this fashion. Whilst many readers here might not be aware of the gravity of this situation, because it’s not common, you care be assured it’s big news. Especially when we remember all except one of these cancers are solid tumors.
LC and her team will be legends if this is how it plays out. I may not have this scenario exactly correct but I’m certain it’s very close. LC is planning a very fast run to the finish line. CF33 approved for use in humans.
So where to from there. It’s a bit hard for the FDA to approve CF33’s use in 3 or 4 cancers to then ask for large Ph2 and Ph3 for other cancers. If she pulls off early approvals the flood gates will be open.
Just my thoughts.
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