Replies to post #4222 on Dendreon Corp fka DNDNQ

[iwfal]

Those are valid points raised by Toos...the question remains, though, did DNDN respond to the FDA prior to PDUFA with the necessary corrections to the issues outlined in the 483?

The point is - how much does it matter if they were minor points that would have gotten signed off in less than 3 or 4 months?

I believe that you would have considered an approvable (or approval with a lien? - not clear to me how they would have worded it) with the only lien being something worked off within 90 days to have been a home run. I certainly would have.

I understood the 'might as well give them an approvable if they have a manufacturing issue' argument but I think this is a very weak argument if the 483 is something that could be worked off in 60-90 days.

[rkcrules2001]

Toos 483 comments

I assume the fact that NJ is producing Provenge for the trials is unchallenged, since there is no other location that can produce Provenge, and we would have certainly heard if the trial sites could not obtain Provenge.

Given that, I certainly agree that this production for the trials is extremely meaningful.

It likely means the 483 observation is focused on scaling issues. For example, there could be some manual process now in place that is satisfactory for current low volumes, but either this manual process would not be compliant at higher volumes, or DNDN's proposed automated process is not viewed as compliant. I'm talking about some inventory control, or QA sampling, or lot management process for example.

But the fundamental manufacturing processes themselves are apparently not being challenged by FDA, since trial production continues.

I'm still struck by the inconsistency of minor, and not resolved by May 8, however.

Perhaps as maharajah described, the official clearance of the 483 has been hung up in paperwork and re-inspections, and since it wasn't "officially resolved" on May 8 FDA was obligated to mention it in the CR letter.... (and somehow Gold felt its mention in the CR letter required public disclosure, whereas the original receipt of the 483 back in February was viewed as inconsequential?).

Dunno. Lots of questions that seem easily resolvable if Gold would simply explain in plain english what the 483 was about, and what they've been doing since February to clear it.

One mystery, for example: If nothing else, post AC you'd think Urdal would have been in overdrive, in constant contact with the FDA inspection group that issued the 483, begging and pleading for them to finish their paperwork or re-inspection before pdufa, so that the decks would be clear when the expected CBER approval came. Even if there is no illegal or unethical angle here, this just strikes me as quite incompetent.

[Gametheory101]

the question remains, though, did DNDN respond to the FDA prior to PDUFA with the necessary corrections to the issues outlined in the 483?

The PDUFA date was May 15 and the FDA kicked DNDN in the shins on May 8. If correcting the CMC issues was the issue, it is inconceivable the FDA would not have given Dendreon until May 15.

The approvable letter is about wanting 9902B survival data. The lawsuit goes nowhere even if it backed by the former most recommended poster per posts.

Bankers almost certainly sign the same confidentiality agreements that potential partners sign and the "books" are opened up to them. In theory, none of them are allowed to trade on this information as the same rules now apply to them as apply to anyone with "insider knowledge."