Hi Jip,
I have mentioned previously that gastric cancer has rare disease/orphan status in the USA (affecting less than 200000 of the population). IMU can apply for orphan status for Her-Vaxx in the USA to treat gastric cancer.
Orphan status comes with many benefits & because gastric cancer is classed as a rare disease, this requires a single phase 3 trial, and importantly smaller numbers on the trial than what you would see otherwise, due to a smaller patient population to recruit from.
This is a helpful blog to explain things briefly, & also a lot on FDA website if you want to read through all of that.
https://www.nuventra.com/resources/blog/orphan-drug-products/So I would say that with the funds IMU have now, they would be more than able to run a Phase 3 with Orphan Status in the USA, and potentially accelerated approval from the FDA on interim results. Rare disease status does not require thousands of patients, it may only be a couple of hundred on a Ph3.
This does not mean that later on, Her-Vaxx may be approved for more common cancers, but Orphan status is valuable to biotechs & Pharmas with the benefits provided both during and after market approval (see article above).
Whether IMU go down this pathway for Her-Vaxx, I don’t know, but it certainly makes sense to me.
Not discounting the China theories either, I think they have the largest global population with gastric cancers.
GLTAH
