Biotech Values

[DewDiligence]

Re: Fast-track status and Orphan status:

>> In June 2003, received CA4P FDA fast track designation for the treatment of ATC. In July 2003, the FDA awarded orphan drug status to CA4P for the treatment of multiple forms of thyroid cancer including ATC… For me this is "evidence" that toxicity is not a big issue. Still, the [January 2004 Clinical Cancer Research] article is written and published and it makes me a little bit confused. <<

mid_swe et al: I think it’s a misconception that fast-track status and orphan status are a signal that a drug candidate is meritorious. Rather, the FDA’s conferring fast track and/or orphan status on a drug says more about the indication a drug is aiming to treat than it says about the drug itself.

In a disease with no approved treatment, almost any drug candidate can apply for –and receive— fast-track status. If the addressable market for the disease is small, orphan status is easily obtained as well. However, neither status (fast track or orphan) implies that a drug is free from defects and is likely to be approved by the FDA for marketing.