Correct me if I am wrong on these assumptions based on my optimism and what i think we know:
1. Phase 1 will likely prove low adverse events, similar to our antagonist Efti in oncology settings; and
2. Phase 1 will provide critical PK and PD info; and
3. When Phase 1 meets its endpoints if all is well …
4. Phase 2 can be designed, approval sought; and recruitment undertaken … this is not cancer, and there is a very high unmet need, so is it not fair to assume this could all happen in 2025? ; and
5. because it is not cancer, I assume Phase 2 trial endpoints can be known very quickly because patients will feel the improvement practically immediately. No need to wait years for mOS etc.
6. that said Phase 2 QoL efficacy over sometime (say 6 months?) will be needed.
I know this is optimistic and simplistic, but this could an absolute blockbuster with a massive TAM in unmet need …. Am I wrong?
So I am very excited about the potential. Well done IMM team.
Regards
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