Replies to post #4152 on Dendreon Corp fka DNDNQ

[DewDiligence]

IMHO, this latest lawsuit is the last straw—DNDN in its current form will probably not survive until the 9902b interim look.

[walldiver]

So let's say hypothetically that DNDN completed a detailed response to the FDA mfg inspectors for everything the inspectors detailed in the Form 483...let's say DNDN did this in early May 2007. The question then would be if anything in that Form 483 requires a reinspection of the NJ plant by FDA mfg inspectors. If so, then the FDA needs time to look over DNDN's responses to Form 483, and then schedule a reinspection. Let's say that FDA finishes looking over the company's responses by June 1st. If so, then would the new PDUFA date be 12/1/07? FDA could reinspect in 9/07 or 10/07, in order to allow some time for the back and forth discussions between the DNDN mfg team and the FDA mfg inspectors.

But as of 12/07 we would be getting closer to the 9902B interim unblinding, which will probably take place somewhere between 160-200 events. Maybe the agency was thinking after the positive advisory panel vote that since it might be another six to eight months after the 5/15/07 PDUFA date for DNDN to satisfy the mfg inspectors, then why not wait just a few more months for the 9902B interim survival data to be unblinded?

[nerdseeksblonde]

that sounds more credible
anyway than the last suit. I have to confess to
ignoring some details here on what mgmt said and
the specific trading rules but clearly anything
that gets more disclosure is good for everyone
as long as legitimate competitive interests and IP
rights are maintained.

These are the kind of not-so-publicized things that, if
they exist regardin the clinical dat and are brough out, would extend the class period well prior to the AC meeting.

Whatever happened to the mono data once the tax+pro data came out? Did anyone
ever come up with a model they felt good about or see credible numbers? Instead of the fixation on a stupid accounting judgment, most investors would be concerned about the known attributes of the only near-term product...

[drbio45]

As you remember Staar Surgical took awhile to get their 483's resolved but it was always disclosed.

this is a big deal.

[iwfal]

issued to Dendreon what is known as an FDA Form 483, Inspectional Observations Report, which cited various violations of FDA regulations at the Dendreon facility.

...

the issuance of a Form 483 made it highly likely that FDA approval would be delayed substantially past May 15, 2007, the anticipated FDA review date

The problem here is that the ambulance chasers are not known to be reliable interpreters of fact. And CMC issues come is a remarkable gradation - from the take-a-week-to-fix to shut--it-down-for-a-year. If the 483 is, as Dendreon suggests inre the approvable letter, a minor one then it wouldn't be 'material' even if they had a 483 ahead of time. I'd be surprised if >50% of first time inspections of new facilities don't result in a 483 - and that most are never reported since they are considered non-material.

BTW - Almost all classes of auditors/inspectors work the same way. They feel they need to report something or they aren't doing anything. That is why it is a very good bet that a very high percentage of CMC inspections find something.