News: IMM Immutep Receives FDA And Irb Approval In The Us For Phase Iib Tacti-003 Trial In Hnscc, page-21

A FDA bridging study is a study performed in a new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen that will allow extrapolation of foreign clinical data to the population in the new region.For example if the FDA fast tracks EFTI for HNSCC and we get approval, we still don't have a breast cancer indication.

We do know that certain breast cancer subsets do extremely well with EFTI. Initially in Spring 2020 Immutep reported "Efti did not prolong overall median PFS in women with HR+ MBC receiving first line chemotherapy... Relevant subgroups and overall survival will be investigated." The stock tanked. Then 6 months later "Immutep Reports Statistically Significant Survival Benefit for Key Patient Groups in the Ongoing Phase IIb AIPAC Study in Metastatic Breast Cancer" Data with immune therapy improves over time. At 5 years we saw the only survivors in the PD L study were in the treatment groups. I suspect we will see the same with eftilagimod.

In Novemeber 2020, before the latest AIPAC results were known, Immutep announces a new license and collaboration with Labcorp, "with further potential commercial milestones and services payments." Not only can Immutep generate profits with Labcorp but this agreement allows Immutep to find those patients who will benefit from eftilagimod! The advantages of eftilagimod treatment will be seen sooner than in the original AIPAC study as the eftilagimod non responders are eliminated.

Approval should occur quickly for an effective and safer treatment. Maybe 24 months.