Biotech Values

[DewDiligence]

Re: Fast Track and Priority Review

>Myogen received fast track status…People confused that with priority review. They aren't supposed to have anything to do with each other.<

They are not completely unrelated. Fast Track has little importance per se, but it does make it more likely that a drug will get Priority Review because there is presumed to be an unmet medical need.

Priority Review without Fast Track is common. (Lucentis is the latest example.) Fast Track without Priority Review is rare; when it occurs, either there is something wrong with the drug or the unmet medical need has been met by another therapy since the Fast Track designation was awarded.

As has been noted on this board, news of a Fast Track award is often a good shorting opportunity because many investors think it means more than it does.