Yeah, I can get some of them. They are broken down like this:

Establishment Fee – The fee you pay for any given facility that takes place in the manufacturing process of this drug. This is an annual fee to cover FDA inspections of your manufacturing processes and techniques to make sure that they meet cGMP requirements. Once an establishment has paid its fee for the year, you don’t owe it again. It’s a once per year per facility fee. Obviously, if I build my own facility, I have to pay the fee on it. This is $57,000 per year.

Sponsor Fee – This is usually a fee that the company promoting the drug must pay. It’s for the FDA to review/monitor the credentials and studies that a company does to make sure that good scientific methods are being followed, that sort of thing. It’s an annual fee that the company pays only once regardless of how many drugs they are sponsoring. It’s also about $55,000 per year.

Drug maintenance fee – This is paid annually on all already approved drugs that the sponsor intends to keep selling. This is for the FDA to keep up with the various drugs and make sure they are keeping only approved items on the shelves. This is about $5,000 per year per drug variant.

New drug application fee – This is what you pay to the FDA so they can do the full technical analysis of your drug, the safety and efficacy studies, your manufacturing process, etc. This one is $262,000 per drug and is only paid once at the time you apply for the new drug approval.

Now, they have a specific small business waiver that waives the new drug application fee for a small business that’s never filed a new drug application before. That one’s easy to get. There are other waivers possible, but only after the FDA user fee person has evaluated your drug and situation. If the fees would keep you from innovating in the marketplace, or if the fees are excessive because your particular drug won’t need near the oversight that other drugs take, then the fees can be reduced or waived entirely on a case by case basis.

Oh, and as to forecasts, that’s really hard to make a good guess on. There are a number of competitors on the marketplace already, but none that are all natural. Unless we knew how much people were making off those drugs, and how much we might be able to poach their sales, we can’t accurately gauge our own forecasts.

However, I will say that the human market for this type of drug in North America alone is in excess of $8billion a year when you count both over the counter and prescription drugs. The OTC drugs alone are about $1billion a year. So even just taking 5% market share would put you in the $50million revenue range (gross retail, wholesale would be probably no more than half that).

I called SECU about it. They are aware of the problem and are attempting to notify members not to respond as well as attempting to get it stopped. I figure they have more clout with the AG than I do, so that should suffice

We’re on AT&T.

Haha! Tit for tat baby!