A sad situation

Let's assume you have a young daughter with a tumor which has not responded to conventional therapy and the physicians tell you that there is nothing more they do. A small biotechnology company has a compound in developmental research which they hope will treat cancers of this type, but it hasn't been through the required process to get FDA approval and hasn't even been shown to be effective at a given dose or age group.
As a Father you contact the company and beg for the drug to treat your daughter even though you know the outcome may not be positive and the drug itself may be too toxic and could cause an acceleration of her demise. What do you do if you are running the company? The only way you can develop the drug for FDA approval is through controlled studies of appropriate patients. If you give the drug to patients without the study parameters being established, you could forfeit the potential to develop the drug for numerous other patients.
This situation in various forms is facing parents and companies every day and a decision on the best way to handle requests for drugs prior to FDA approval is an ongoing ethical problem.