Replies to post #3731 on Dendreon Corp fka DNDNQ

[rkcrules2001]

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.>>

[DewDiligence]

>…after reading thoroughly all of the FDA's criteria for the various letters, I do indeed think an Approvable bodes well for Provenge.<

Please don’t kid yourself into thinking that the word approvable means that the FDA’s response was positive. An approvable letter that requires the results from another clinical trial for the FDA to reconsider the application is a euphemism for a rejection.