GREY:IMVIF - Post by User
Comment by
qwerty22on Mar 18, 2021 4:03pm
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RE:DLBCL trial
RE:DLBCL trial Effectively almost all oncology approvals of new molecules are accelerated approval because they are based on surrogate endpoints. The question to ask is whether they see the 2b as being registrational? I can't remember if they used the r word in the call, they have talked about potential registrational in the past.
Biotech010 wrote:
I spoke to the company yesterday. Doing a phase 2b does not preclude an accelerated approval. In the first part they want to repeat the data they had in the PDL-1 positive population in a greater number of patients. And then they would ask accelerated approval. Interim data is planned for Q1 2022.