Gary,
Just a guess, but since the inclusion criteria is for 5 different cancer types, I would imagine that sample size for each individual cancer would be too low to roll into a registrational study. My guess is 1.) Completion of study 2.) Identify indication/ITT population 3.) if ph 1/2 results are extremely impressive, I would think we have the ear of FDA so the next step would be to have regulators approve/recommend path and analyses going forward. I think there is still a lot to do with this nascent compound.
If all things go swimmingly, could you imagine IMGN in 4 years? Established, high global sales of Elahere; it's succcessor (151) ramping up; sales of Piv. gaining momentum in 2 indications, and 936 ready for take off....Reading a bit on ADAM-9 when 936 hit the pipeline, I recall that this is expressed on A LOT of different cancers.