nuke - if you're using the word 'trial' in the context of producing information that is usable for the purpose of filing, approval, etc. - my answer would be no.
At least historically, and based on how one creates a condition where sufficient controls are in place where an outcome has a direct link to an experiment and a design that sought for that outcome, the FDA would want that type of assurance to proceed with accepting a formal filing for the purpose of a potential commercial and public (no special conditions) use.
That said - there are many major values to collecting and correlating the information they have (and what we know they're sharing);
It helps get leverage with the FDA/EMA (Europe) on more flexible trial design, parameters, entry/exit criteria, etc.
Coupled with new diagnosis options it may help drive faster/less comprehensive measures to determine when something is considered 'working'
It makes it much easier to combine with an existing and approved product (say Opdivo, Keytruda) if it consistently shows that it can do no further harm or even better - help produce better outcomes. So pathway as a combo approval would be shorter and more flexible.
Finally, with Gottlieb taking on FDA lead role, over time - use of secondary or trial extension data (such as Sunrise post halt) may be usable for filing under some conditions. A lot more flexibility is coming to the FDA as the traditional 'one size fits all' approach for gating medicines in and out of the system is recognized as a poor choice for some disease categories. When facing guaranteed mortality and continued down-spiral of health with every day that passes, waiting longer instead of allowing experiments is not the best choice for cancer patients. As one gets weaker and compromised, many potentially great medicines will not work (or become less effective) due to the deteriorated condition of the patient. Fast, aggressive and shifting to different options will be the name of the game as soon as they figure out how to measure response in real time and make quick decisions.
Which is another angle where simple, cheap, accurate and precise (staging, progress, etc.) diagnostic comes in. Treat, measure, evaluate, verify, decide, plan, repeat.
Best,
MH
