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iwfal

06/09/07 10:39 AM

#4167 RE: rkcrules2001 #4165

Every 483 effectively constituted a cease-operations order.

rkcrules - thanks a lot for the reply and the view from the inside. I can certainly appreciate that a 483 to an on-going operation would be very drastic. And presumably rarer than in a new operation. But the question is how rare and impactful they are in a completely new facility - e.g. one where there are no ongoing operations so ceasing operations means little?
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mouton29

06/09/07 11:19 AM

#4173 RE: rkcrules2001 #4165

Is the 483 material?

Well, the convert has not closed yet, see last sentecne of the paragraph quoted below. Let's see whether the offering closes Monday. If this is really material, perhaps you will see repricing or worse.

SEATTLE, June 6 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced the pricing of its offering of $75 million aggregate principal amount of convertible senior subordinated notes due 2014. This offering will be made through a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933. The notes will bear interest at a rate of 4.75% per year. The Company has granted the initial purchaser of the notes a 30-day overallotment option to purchase up to an additional $25 million aggregate principal amount of the notes. The sale of the notes is expected to close on June 11, 2007, subject to satisfaction of customary closing conditions.
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maharajah

06/09/07 11:39 AM

#4177 RE: rkcrules2001 #4165

I am currently involved in this industry, the FDA regulatory side, and everything rkcrules2001 mentions is still valid today. 483s are a big deal regardless of what it is for.