OncoSec Medical Inc (ONCSQ)

[JDUser1963]

Correct. That's what makes it easier to globally register. And that will expedite and streamline the costs for ONCS once they garner device approval.


The interesting aspect f this whole ordeal is: In the US it's a drug and Canada and Colombia (LOL!) as well, but for the remainder of the World including the EU for a CE mark it's a medical device. As a matter of fact the entire World will use the EU CE mark as a determinant for admission by the governing body. They lean on the EU and the US; however, Japan uses the physician exception to an extreme and that makes it easier these days for data. Same used to be said for Germany and Switzerland but the new harmonized EU standards are putting a damper on that now and NEMKO is leading the way so they can monopolize the audit process. Neopulse is already in the books in the EU, they have a hold on it. Why they chose to go US for Immunopulse is because a majority of the journals are in the US and will be very useful as a marketing tool. Add to that the US is also the quasi rubber stamp that the EU is; and now that the EU has NEMKO lobbying it to be more stricter like the US then might as well garner approval here first. No, this kid is sharp and the patent Councel is sharp as well and the new Reg officer was a friend of mine from Biogen. It's a small World.

I know what's going on. I have all the timelines drawn out...the cliff is near for many shorts, some MM's may get notice and pull out first, but it is near. I'm not telling.