Dendreon: Short Squeeze Time

Dendreon (DNDN) came out with positive data Tuesday morning regarding its prostate cancer treatment Provenge trials using immunotherapy. This is really the first possible successful cancer vaccine treatment as everything up until this point has failed using this method.

"Cancer immunotherapy attempts to stimulate the immune system to reject and destroy tumors."

Before you get too over-hyped, Dendreon plans to file the new data with the FDA by the fourth quarter, which could lead to a decision six months later --- so there is plenty of time before the finish line is reached absent a buyout.

That being said, new analyst targets are ranging from the mid to upper twenties using conservative estimates IF (that's a big if) the drug is endorsed by the FDA and Phase IV goes well.

There were and are still many doubters on this name and the short interest was huge going into this news, but this data really is a smack to the face for many of them.

Still the details so far are very short on substance and in the company conference call scheduled for the 28th of this month the company has said it will release the granular details of this latest trial's stats.

I think the shares will probably trade back to twenty before this meeting takes place given the momentum and short fuel fire that this one has.

Disclosure: I do not currently have a position in DNDN but plan on starting one shortly.

Comments

[teddy's cousin:]

Phase IV? What the hell is that? I've never heard of a Phase IV trial. I suggest doing some more DD before you puchase ANYBODY's stock.

Apr 15 08:28 PM

[xxoo:]

I think he probably means the submission of the BLA to FDA

Apr 15 09:12 PM

[DRH:]

It's not that they won't give the details, they can't because the 28th is their presentation at the AUA (not a conf. call) and the actual data is embargoed till then.

Apr 15 10:59 PM

[scooter13:]

Phase IV studies are typically used to expand the indications on the label, and to assess additional safety metrics in target market subset (pregnant women, children etc).


On Apr 15 08:28 PM teddy's cousin wrote:

> Phase IV? What the hell is that? I've never heard of a Phase IV
> trial. I suggest doing some more DD before you puchase ANYBODY's
> stock.

Apr 16 08:30 AM

[Leonard the...:]

Teddy, Phase IV trial's can result in the drug no longer being able to be sold.

You should apparently look it up.

Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses: recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

Apr 16 10:17 AM

[Michael Murphy:]

"IF (that's a big if) the drug is endorsed by the FDA and Phase IV goes well."

Total BS. This trial was conducted under a Special Protocol Assessment agreed to by the FDA. If Dendreon shows a 22% reduction in deaths versus the placebo, they get approval, period. They beat that standard handily. They are not submitting a BLA; they did that three years ago. They are submitting a Type 2 resubmission that takes 6 months.

There is no requirement for a Phase IV or follow-on study, simply because in EVERY Provenge trial there were no safety issues. Patients get flu-like symptoms because that's how an immune-boosting cancer vaccine works, just like your immune system if you get the flu and it needs to fight it off.

NewWorldInvestor.com has been long and right on this stock, and I just doubled my buy limit to $16 for a $40 first target. Every $1 billion in sales is about $25 in current stock value for DNDN. We will see $2 billion to $4 billion in Provenge sales on and off-label in the US and Europe/Japan. And then comes breast cancer, colon cancer, head & neck cancer, stomach cancer - aa relativley simple label expansions of Provenge.

Apr 16 01:05 PM

[polar40:]

Thank you Michael,
Following your newsletter I am heavily invested in DNDN and making a bundle.

Apr 17 01:59 PM

[Leonard the...:]

I just caught an easy 25% profit because the news was already out, the sentiment before hand was extremely negative and the possible outcomes extremely positive.

Those of you investing in it, I wish you the very best and I do truly hope that it exceeds everyone's expectations for the sake of those who need the medicine.

Apr 21 11:41 PM