The incidents mentioned in the Storyline supplied by the network are less interesting than this incident which is not mentioned:
James Bell (the owner of Bunker Hill) has a rare prion-based disease and his life expectancy is a few months. He develops a potential treatment and finds a patient with an advanced form of the same disease. A short period of animal testing has been performed, but it is not enough to convince the FDA representative to allow the treatment on a human. She says that at least a year of animal testing would be required (James Bell would be dead by then).
The FDA representative happens to be Dr. Wallace's wife. That would not be allowed in the real world, because of conflict of interest restrictions (it does enable a fight between Dr. Wallace and his wife). In this case, fast-track approval would normally be given for two reasons. First, the patient has less than one month to live, so only about one month of animal testing would be required (they had not performed a full month of testing). Second, this is what is known as an "Orphan disease," a disease that is rare enough that the normal three-year testing cycle (including over a year of animal testing) is reduced to under a year total. The justification for fast-track approval of treatments for orphan diseases is that normal testing requirements are too costly for rare diseases.
James Bell (the owner of Bunker Hill) has a rare prion-based disease and his life expectancy is a few months. He develops a potential treatment and finds a patient with an advanced form of the same disease. A short period of animal testing has been performed, but it is not enough to convince the FDA representative to allow the treatment on a human. She says that at least a year of animal testing would be required (James Bell would be dead by then).
The FDA representative happens to be Dr. Wallace's wife. That would not be allowed in the real world, because of conflict of interest restrictions (it does enable a fight between Dr. Wallace and his wife). In this case, fast-track approval would normally be given for two reasons. First, the patient has less than one month to live, so only about one month of animal testing would be required (they had not performed a full month of testing). Second, this is what is known as an "Orphan disease," a disease that is rare enough that the normal three-year testing cycle (including over a year of animal testing) is reduced to under a year total. The justification for fast-track approval of treatments for orphan diseases is that normal testing requirements are too costly for rare diseases.