Phase 3 will have to be done for full approval. But given the extraordinary OS results in low monocytes, no side effects other than injection site irritation and 20% durable CR’s in head and neck and very promising results in NSCLC something has to give. They can’t sit on a product of this quality and efficacy.
I believe we will get provisional approval early in a number of indications and for patients with no further options. Trials will also be fast tracked and shortened, imo.
Looks like we might come back to the raise price again. I’m waiting!
Phase 3 will have to be done for full approval. But given the...
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