DNDN - Dendreon Corporation (NASDAQ)

[marketwatch]

DNDN up 12% today and near it's all time highs based on rumors of a ROW partnership announcement soon (CC is Sept 24th) and on rumors of a buyout ($40.00 is the number being thrown around).

[basuanand]

I have also heard about these rumours. But I read somewhere that Dendreon management is not interested in being acquired and is looking for a marketing partner for Provenge.

[at109]

Does anyone know PDUFA date?

[waves]

DNDN has not filed NDA yet. So no PDUFA available. They supposed to file NDA soon (probably 1H 2010). Do your DD.

[dilzniksan]

DNDN currently has ~17K calls open interest at a strike price of 40$. Does this mean that $40 is a good short term sell point? Or does this indicate that there are many bets that it will go higher?

Also, this has me extremely worried. Granted its only one investor, but, this individual is betting on a near term collapse in DNDN's sp. I am reminded of april 09....

[NHBI]

What concerns me most about DNDN is the potential that the survival data from their pivotal IMPACT trial could be compromised. DNDN said that the FDA allowed them to "peek" at the data in Oct 2008. At that point, the trial hadn't reached the pre-specified endpoint of showing that Provenge provides at least a 22% reduction in risk of death versus placebo. It was sitting at 20% at the time. 6 months later, as patient monitoring continued and more trial patients died, Provenge miraculously edged ahead of placebo by 22.5%.

There's precedent for the FDA nixing trial data due to technicalities before.

I might short a small smount of DNDN going into the May 1 PDUFA, probably @ close to $40. FDA approval is pretty close to completely priced in, in my opinion. Upside for FDA approval: $45-50 PPS. Downside for a bad decision: $5-10 PPS.

[marketwatch]

What concerns me most about DNDN is the potential that the survival data from their pivotal IMPACT trial could be compromised. DNDN said that the FDA allowed them to "peek" at the data in Oct 2008. At that point, the trial hadn't reached the pre-specified endpoint of showing that Provenge provides at least a 22% reduction in risk of death versus placebo. It was sitting at 20% at the time. 6 months later, as patient monitoring continued and more trial patients died, Provenge miraculously edged ahead of placebo by 22.5%.

There's precedent for the FDA nixing trial data due to technicalities before.

I might short a small smount of DNDN going into the May 1 PDUFA, probably @ close to $40. FDA approval is pretty close to completely priced in, in my opinion. Upside for FDA approval: $45-50 PPS. Downside for a bad decision: $5-10 PPS.

This trial and endpoints were agreed to by the FDA under a SPA, DNDN had the green light to take the peek at the IMPACT trial in an amendment months before the peek occurred. If the peek showed that the SPA approved interim endpoint was met the trial would have been deemed a success if not, as we saw, the trial would continue on until the trigger event occurred at which point the final data would be reveled and had to show that the SPA approved final result endpoint was met. As we all know this endpoint was crossed and the trial was a success. Having the SPA agreement with the FDA for this trial removes the fears of having statistical technicalities. Couple this with the fact that the FDA gives a drug maker 55 days notice before a advisory committee and we are only 37 days before the the May 1 PDUFA, the approval writing is on the wall flashing green.

As far as FDA approval already being priced in (or close to it) I would strongly disagree with you. DNDN estimates that it will be able to produce $1 - $2 billion in the first year it is approved and their research shows demand will be high. ROW partnership is still to come and I predict a Time Magazine cover for Provenge & Dendreon will be forthcoming later this year. I think we cross $60 easy on approval.

[NHBI]

This trial and endpoints were agreed to by the FDA under a SPA, DNDN had the green light to take the peek at the IMPACT trial in an amendment months before the peek occurred. If the peek showed that the SPA approved interim endpoint was met the trial would have been deemed a success if not, as we saw, the trial would continue on until the trigger event occurred at which point the final data would be reveled and had to show that the SPA approved final result endpoint was met. As we all know this endpoint was crossed and the trial was a success. Having the SPA agreement with the FDA for this trial removes the fears of having statistical technicalities. Couple this with the fact that the FDA gives a drug maker 55 days notice before a advisory committee and we are only 37 days before the the May 1 PDUFA, the approval writing is on the wall flashing green.

As far as FDA approval already being priced in (or close to it) I would strongly disagree with you. DNDN estimates that it will be able to produce $1 - $2 billion in the first year it is approved and their research shows demand will be high. ROW partnership is still to come and I predict a Time Magazine cover for Provenge & Dendreon will be forthcoming later this year. I think we cross $60 easy on approval.

Demand is high, but the price is also high. $60,000 per treatment course, at least. Have the major insurance companies said they will cover this? Otherwise, it's a treatment only affordable to the rich.

Don't get me wrong. Dendreon is a pioneer and we all want them to succeed because it paves the way for other companies.

[biotechbob]

What are the chances that the FDA denies Provenge? That is, what might possibly guide their decision for a negative outcome? It seems highly unlikely, but I like to look at both sides before deciding to buy into a stock.

[Docreech15]

I'm not in DNDN but after reading the posts of other members that watch this very closely, I would have to say it's a 0% chance of denial

But u never know