The most vital aspect is to ensure that the tumours detected by Cu67 are real or false positives. If they are real then the Phase 3 will be a slam-dunk and bisSAR-PSMA will sweep the market.
There are a number of ways the tumours missed by conventional imagining can be proven to be real, but the simplest would just be to biopsy a representative number of them and determine how many are real. I am certain CU6 will be having some interesting conversations with the FDA about what they need to show in the Phase 3 and they will come to an agreement with the FDA on what is needed for approval. The FDA wants to see better treatments make it to market, and like they have done earlier, I expect they will be very accommodating with CU6.
The most vital aspect is to ensure that the tumours detected by...
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