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Re: artavia2007 post# 3731

Tuesday, 05/22/2007 9:22:34 AM

Tuesday, May 22, 2007 9:22:34 AM

Post# of 12660
artavia2007 -- approvable vs major deficiency

<<Quite - you've exactly perceived and articulated my underlying meaning in my query - that the reactions and discussions suggest a "Major Deficiency" letter was issued, rather than the "Approvable".>>

In their PR they explicitly used the term "approvable" --

"SEATTLE, WA, May 9, 2007 – Dendreon Corporation (Nasdaq: DNDN) today announced that it received a Complete Response Letter, commonly referred to as an "approvable" letter, on May 8, 2007 from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for PROVENGE"

Could they defend such language in the PR by claiming that official "Approvable" and "Major Deficiency" letters are both commonly referred to as "approvable" letters?

If PGS's post is correct, such a defense would not seem feasible -- PGS:
<<The major deficiency ruling is often referred to as a "refuse to file" in most of the press.>>


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