Joe gave an informative response in the CC that ou

Joe gave an informative response in the CC that outlined how things get delayed. The following is in regards to IND approval in July.

“To get the approval, yes. It's our approximation. Now, understand, because we are constantly doing different experiments and there's different processes that we have to do to finish the CMC, things change. I’ll give you a couple of examples. Now, I believe we would have been done months ago--and I know we would have been done months ago.

But when we did the immunogenicity study with the mice with the human alleles, the mice, unbeknownst to us, had COVID. So, someone must have sneezed on the mice that COVID; some way, somehow, the mice got COVID.

So, when we tested our vaccine and the mice, they got the vaccine, they gave a great immune response and a great IV response. But when we tested the mice that got placebo, they had a neutralizing response and that's not supposed to happen.

So, what happened is the mice got COVID. Now, they weren't symptomatic, there's no way of telling if the mice got them; the second time we did it, we could test those mice now, we took blood from the mice to make sure they don't have COVID, but believe it or not, they got COVID. So, that set us back 60 days.

Or look at our manufacturers. So, we had one of the premier large manufacturers that's doing all the big COVID fill-finish, and we got bumped from one of the Big Pharma and instead of getting fill-finish started in April, they pushed us out to November. So, we had to scramble, we had to find another premier fill finish and get put into the slot. When we were put into that slot for May 18th, but they're doing all the work that leads up to that commercial run of our vaccine; we've already done the three engineering laws, we've already done the packaging on the three engineering runs, we've already done the mixing, we've done all the testing, but now we have one last big thing which is the commercial big run, which will be done in May--started on the 18th.

So, again, there's no way of ever telling, science evolves daily right, and the amount of experiments that we're doing evolves daily and we make things better as we go; and then as problems come up--I mean we didn't know that we could make a lyophilized version of the vaccine, so we had to test all that; we had to see if we can turn that liquid into a powder and will it still be that effective as it was the liquid?

So, all those things as we're going, we add, we take away, but mostly, we've been adding and that just makes our IND package 100 times better than where it was each and every month.

So, that's why we keep doing that--because COVID is not going away it's never going to go away. And I believe--again, it may vary from my team, but I listen to the CEOs of these companies and they're saying, "You will need a booster; so next year, you're going to need another shot." So, for me, I don't care if all 8 billion people in the world get vaccinated, next year you're going to need another shot and why wouldn't you want the safest, most complete vaccine which will be us?”