Replies to post #3714 on Dendreon Corp fka DNDNQ

[poorgradstudent]

The major deficiency ruling is often referred to as a "refuse to file" in most of the press.

That is a ruling from the FDA that the submitted application is lacking information that makes it impossible for the FDA to render judgment. In other words, there are clinical data missing from the BLA, manufacturing details are missing, etc...

The opportunity for a major deficiency letter rests at ~60 days after the initial BLA submission by the sponsor. For example, IMCL received this "major deficiency" ruling, or a refuse to file.

Once the FDA accepts that it has all the information available to render a judgment, the possibility of a "major deficiency" ruling has passed and you're into the approved / approvable / not approvable scenario.

[DewDiligence]

[OT] for Artavia: >I originally posed this query to Dew on the IV mb, but received no response.<

I replied to you yesterday in an iVillage private message. If you click on the Inbox link, you will see it. Regards, Dew

[scha6ab]

Assuming this is in fact an approvable scenario, dont you think this bodes well for DNDN? That possibly there is either some minor clarification on their part or they need time to complete enrollment. Which the news today from the AUA would definitely help that cause, as well as upcoming ASCO publicity. If this is the case how can the analysts who are so called "experts" in biotech not pick up on this? It sounds to me that they are purporting this to be more in the major deficiency camp, but how can the lines be blurred on this classification. I am a so very confused on this point, who do you believe. The two we need to hear from DNDN and FDA are understandably on self-imposed gag orders until next month. I guess we'll just have to wait and see.