Replies to post #4167 on Dendreon Corp fka DNDNQ

[rkcrules2001]

iwfal -- 483

<<how rare and impactful they are in a completely new facility>>

Yes, with a new facility and an unapproved product, there would presumably be no immediate impact from the 483. As you note my experience was with large ongoing operations, hence immediate negative impact, and hence hypersensitivity.

But I'm still confused. Anyone involved in pharma knows that 483s are never 'minor' -- again the fix might be minor, but the impact is nonetheless huge. It is an absolute no-go on operations. I just can't reconcile some the 'facts' and claims here.

-- The 483 was issued in February.
-- Gold says its substance was 'minor'.
-- It is still not resolved on May 8.

So it's such a minor issue (so easily fixed?) there is no need to tell investors? But then why is it still unresolved 3 months later? Was 'resolution' simply awaiting some re-inspection or other beaurocratic process? My recollection was that FDA would remove a 483 as soon as the cause was remedied. (Again, though -- this was big pharma, ongoing ops.)

This raises my curiosity about Urdal. He is the big kahuna internal shareholder, more options and shares than anyone else. And he sold zero after the AC.

My initial assumption was this indicated he was absolutely confident of approval. But he is in charge of operations, so within DNDN he would own the 483 and its resolution. He would know better than any other exec how minor it really was.

Did he not sell because he knew an approvable letter was coming because of the 483? (He may still have been surprised along with everyone else that the CR letter also said that more clinical efficacy data was needed.)

Obviously all that is just speculation. And I suppose it is conceivable the 483 issue may turn out to be nothing, truly minor. But the people behind the new lawsuit apparently don't think so.

Lastly -- I too would like to know the answers to your questions about 483 frequency and impact on startups like DNDN's NJ facility. My guesses are -- infrequent, and significant. Nobody would want those "flunks" on the record -- raising future auditor sensitivity, etc...... To fully beat the dead horse: they are a big deal.