Monday, June 10, 2019 5:10:46 AM
1. How many patients will the FDA require? Will the 50 patients we plan to enroll suffice?
2. How long need CTC levels and tumour shrinkage to be observed?
Given the huge unmet need, I think (1) won't be a problem, if results are very clear and impressive, but I think they will need all 50 patients. I also suppose that they will still be required to show reduced CTC numbers over a certain period of time to prove that the effect persists, for a couple of months at least (just guessing).
That puts us at 6? months after full enrollment, which at the current pace of enrollment might be more a year away, so I would guess 2H2020.
All in my totally unqualified opnionion.
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