FDA

“We got approval from the FDA and we did a full recall within hours, which meant that that 265 tons of ice cream that had been out in the world came back to us.”

“The FDA actually did this thing called the emergency use authorization for. For masks, and they let us in that right away. And then we Actually, like I said, we did a lot of things, and we got lucky, and the batch of masks that we had created lined up, and we …”

“We'll be, you know, probably a small handful of restaurants around the country when, once we get that green light, but we actually have started conversations with some of these big grocery chains.”

“So to develop a new immunotherapy takes more than 2.6 billion dollars. It takes more than 10 years of research and development before market. And more than 90% of drugs fail To get an FDA approval.”

“Transparency with consumers right now is huge. I think people have realized that they can't trust all companies. Before, when we were growing up, if we assume that the FDA was protecting us and that there were someone, some government authority protecting us a…”

“After two weeks, we're just waited, you know, waiting to see the results, and they didn't find one issue, and so it very well could have been a false positive or an ingredient issue.”

“Our biggest inhibitor and why we haven't done it yet is all the fees that the FDA charges. So it's about 365,000 dollars to set up what's called an end on new drug application.”

“So we had an investor come forward that we had spoken to in the past as well, and they ended up funding the business another four million dollars, which allowed us to spend the next 18 months, get our product off the line at this facility and into the FDA.”

“And they issued a national recall. Right there and then. Issued a national recall of what was a pilot”