Biotech Values

[AlpineBV_Miller]

re: response letters

When the FDA agreed to industry requests for changes in nomenclature of the PDUFA responses, the idea was the initial letter sent to the companies would be clearly labeled as to the type of class. I think what's going on is most execs don't understand (or know) the importance between the two classifications. Alternately, they are purposefully being obtuse.

Two years ago, the FDA agreed to eliminate the terms "approvable letter" and "not approvable letter" from their lexicon. As near as we can tell, companies still adhere to the terms though the responses from the FDA don't contain the words. Technically, companies now get a "complete response letter", a term you irregularly see in press releases.

We've been on calls with management who insist they do not know the FDA's timetable for review of a response letter, then turn around and tell us the response was designated a class two.

The bottom part of this article describes the situation as of June 2004.
http://www.minyanville.com/articles/index.php?a=5037