FDA

“Because of the way the FDA regulates these products, it's very hard for us. Like we can't put caffeine in our gum that has nicotine in it. You can't mix actives, but if you're more of like a health clinic, you could actually prescribe caffeine, nicotine differ…”

“The other issue with the compounding just from a business perspective is that I think that you're only allowed to do it from an FDA perspective when it's on shortage. And so you can build up this revenue stream and you can get subscribers, but then it could ge…”

“And notably, like big companies right now with big startups like Neuralink and Synchron, like these big brain computer interface companies, you know, which have breakthrough designation, which was, you know, prized as like the fastest, most expedited pathway i…”

“So they just recently released the guidance that certain biologic drugs, antibodies don't have to go after as much animal testing. You can leverage a lot of human clinical trials, which is like almost incorporating common sense, right?”

“So I think ultimately it will be approved.”

“So I think ultimately it will be approved.”

“The FDA is able to put an import restriction on the company, so they're making the product, I believe, in China, probably overseas somewhere, because it's electronics, it's equipment. They bring it in at the ports, and the FDA says, hey, while we sort out this…”

“Going forward, new products that contain nicotine, that contain tobacco, We want to review it before it hits the market, but we're also going to create a grace period for stuff that was launched before 2016. Anything launched before August eight, 20 16. You ca…”

“Later, a hedge fund guy actually buys the company out of bankruptcy, turns it around, gets it FDA approved, and sells it to Altria for like a couple hundred million dollars, or maybe actually a couple billion dollars, I think.”

“Then they wind up splitting the company once both products are kind of taking off, but they're on very, very different trajectories. And it's very clear that They will be under very different regulatory regimes”

“You could spend millions of dollars and wait a decade, which is exactly what we did. But we were able to actually grow the brand and sell the product and like set up operations and iron out things and iterate a little bit during that time, fortunately.”

“The FDA has issued marketing granted orders. These are MGOs. We'll get into this, but it's, like, slightly different than, like, FDA approval for a drug for the Juul system, recognizing that these products, as appropriate for the protection of public health, t…”

“I think that we will exceed them in value in many core areas. Because they, you, they can take, you know, well-structured, well-funded clinical trials. But then other things like peptides that are very promising. They're not going to have the clinical work.”

“I believe the FDA will make it legal to compound soon.”

“I think you can shut it down, and then I also think that we have a perfectly great system, which is the normal regulatory body we've had for 60 years. And creating, like I said, a new special ed version of it, For drugs that couldn't quite get on the school bu…”

“Taking Eretta Trutide, which is just sort of a GLP plus, if you will instead of just waiting it for it to be FDA approved, or like, Using Ozempic. I think this is like the worst risk reward decision you could possibly make.”

“Lucy cannot make quit claims about the nicotine gum product. So even though most people think, oh, this is like Nicorette, it's actually regulated in a different category. It's regulated as tobacco product, not as a pharmaceutical product.”

“So Medvi received an FDA warning letter just two months ago for misbranding violations.”