Let’s start with an interesting question. If you had $ 500 million dollars and were given the option of either 1) buying a professional sports team or 2) paying a drug to get through the FDA development process and then owning the rights to that drug Being whom you choose?
The average person does not realize that those two options are of equal value, but they actually are. Obtaining a drug approved by the FDA is expensive, time consuming, and risky. You may browse the web to search FDA tentatively approved drug lists.
Only one in five drugs actually makes it through this process, and the expense of doing so is challenging. If the medicine makes it and the disease it treats is fairly common, revenue potential can be tremendous.
Therefore choosing option 2 may pay better than a professional sports team. Most sports teams are also scrapping proposals from year to year, but at least they are appreciating assets that generate revenue.
Once a drug is synthesized in the laboratory or purified from a natural source, the next step is usually animal testing. Common animals include mice or rats.
This is called the preclinical phase of testing, and if successful a new drug (IND) application is submitted to the Food and Drug Administration (FDA). Ind is a human testing protocol within the application. The FDA can counter the protocol, but if the manufacturer cannot begin testing after 30 days.