RE:RE:RE:RE:Webcast
Look at the presentation, they're doing the Phase 2 OC trial in monotherapy. Below the answer from the CFO.
For ovarian yes, we plan to meet with the FDA to discuss registration trial as a monotherapy. In other indication the strategy is still combination. On the basket trial we will disclose some information on the cost in our MD&A that will be filed on Friday.
So I guess Merck and IMV will partner eventually in some way. And IMV will use the new capital from the US placements to finance the monotherapy.
Further, read this: Using surrogate or intermediate clinical endpoints can save valuable time in the drug approval process. For example, instead of having to wait to learn if a drug actually extends survival for cancer patients, the FDA may approve a drug based on evidence that the drug shrinks tumors, because tumor shrinkage is considered reasonably likely to predict a real clinical benefit. In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually predicts that patients will live longer. These studies are known as phase 4 confirmatory trials.
This from https://www.fda.gov/forpatients/approvals/fast/ucm405447.htm
If you read the new presentation, they talk about Tumor Shrinkage!!!!!