DNDN - Sector: Healthcare---Industry: Biotechnology & Drugs

[saffeysite1]

Two biotech stocks that reported great results today on theri cancer drugs at the annual ASCO.

Look to see these gap uip on Monday morning.  If tthinking about buying, wait till the gap settles down to get in.

[David Randolph]

Just let me leave the charts on CTIC and DNDN:

[saffeysite1]

Dave,

After taking a closer look at the charts.  Both of these are coming of their 52 week lows.  Risky trades for now.  News maybe short lived.  Keep on watch list.

[stockpicker]

DNDN has an excellent story... long, complicated but interesting

little risk with the clinical data
some risk with production
first vaccine drug, ever

if apporved, it's a $40 stock

[bula]

--- my next call will be DNDN (riskier than AMLN, though), I'll write a few words about it tomorrow ---

Still awaiting your post on DNDN, but don't want to steal your well deserved thunder.  The chart does looks primed for a break.  Just needs a bit more volume.  But it's as repressed as AMLN was and then some.  I bought in today at $5.15.  Hoping for an afternoon breakout. 

[bula]

Pretty sweet chart break.  Still needs help to get through resistance at 5.35, but it looks like an oversold opportunity here.  Looking for $6 short term.

[marshagogo]

Thanks for bringing this one up. I also bought in at $5.17 today. I think it looks primed
for a move as well.

[stockpicker]

DNDN's is a much riskier play than AMLN, however, the upside for this $5+change stock is around $40-50 if its leading drug candidate, Provenge, will be approved. Please find below a little background (soory, had no time to edit it) and I will be happy to hear your remarks (especially regarding the TA). Please also feel free to ask technical and business questions. I am following DNDN for quite a while so I think that I can handle most Qs.

Godd luck!


The Science
Dendreon's (DNDN) leading drug candidate is Provenge, a dendritic cell vaccine for late stage Prostate Cancer patients. It is working on stimulating the immune system to fight various cancers. Dendritic cell vaccines must be made individually for each patient. The process used to create them is involved and expensive: Scientists remove dendritic cells (from the patient's white blood) and make them reproduce rapidly, and then "teach" them to recognize cancer antigens by exposing them to the antigens in a dish, or by genetically modifying them so that they make their own.


Clinical Trials
DNDN has been running 3 different phase-3 trials: 9901 (completed), 9902A (top line results due this summer) and 9902B (final stage of enrolling). I will not get into the details of each and every trial (you can read a lot about them on DNDN's Yahoo MB, but if you REALLY want – please ask and I may make another post with these details). The bottom line is that the company did a BAD job in designing the trials. They were looking for the quick benefit – "time to progression" (TTP) – and failed (in 9901). However, later on, they realized that despite bad TTP results, Provenge provides excellent survival data – and the "gold standard" of the cancer drugs is survival, whereas TTP is a surrogate result (and there is a detailed scientific explanation why DNDN's TTP failed while the survival results were great). By combining the data of the 9901 and 9902A trials, DNDN is expected to show statistically significant survival results.


The Risks
1.   One may assert that DNDN are trying to change the rules of the game. They have defined, together with the FDA, the primary and secondary end points. They have failed to reach them, but now they show that they actually improve THE MOST important criteria in cancer drugs – survival. Will the FDA accept this? Well, IMO, they will, since there are no other treatments for advanced stage prostate cancer.
2.   Provenge is not a "one drug fits all patients" kind of drug since it is based on the patient own while blood cells – I foresee that the FDA's main concerns will be here and not regarding the clinical results.
3.   There are no approved cancer vaccines – it is always hard to be the first one


The Potential
1.   Being the only prostate cancer drug – this is a HUGE market and it is likely that doctors will use it beyond the limitations of the label
2.   The company has over $200MM cash which is sufficient for nearly 2 years
3.   The company has announced that 9902A results are going to be "similar" to 9901, hence, the pooled data will be sufficient for approval
4.   Once approved, DNDN will be a $40+ stock, if not much more; if the FDA will not accept the drug, DNDN falls to around $1-2. At the current $5+change pps, the risk-reward is amazing.
5.   Huge short position


Time Line
Results of the 9902A trial are going to be announced this summer (and if they are "similar to 9901" – DNDN jumps to the low teens; if they are "statistically significant as stand alone – DNDN jumps to around $20). It is going to take DNDN months to prepare the BLA for the FDA. Provenge has a fast-track status, so if the results are OK (and it is pretty much likely that the clinical results are great) – the FDA will likely to approve Provenge around mid-2006.

[eliteG]

stockpicker  ,

A truly excellent post!(applauded)  I believe the chart technicals will tell us what the results will show before they are out.  Will keep a close watch.

To me this is a radical concept.  To teach white cells how to fight for each individual patient.  I hope they succeed. 

Looking forward to more of your posts

[bula]

Stockpicker thanks for the post.  I was waiting for that.  I'll move my previous thread on DNDN here .. ref http://www.3stocksonfire.org/trading/index.php?topic=672.0

I bought in large at $5.15.  My kinda momo stock.  My previous chart posted yesterday is here.  The break over $5.35 chart resistance is crucial.

[bula]

Tough hold now, stop set at $5.08.  Resistance at $5.35 was tested but not broken.  We'll give it one more shot.  If it breaks $5.35 on volume, this one is golden.

[bula]

I sold today +.05.  I want to see this one break $5.35.  When it does, i'll come back in full force.

[Ramsburg]

Nice research on this one stockpicker

I must applaud you !

This stock it's starting to look nice on a technical analysis approach, it maybe starting a reversal, and even its going down today, I have to put this one on my watch list.

regards and keep up the excellent quality of your posts !

[stockpicker]

thank you very much for the feedbacks and I apologize that DNDN didn't work for you instantly ... this is not a day-trade stock

I hold a core position and wait for this summer's pop once the trial results are out

I'll keep you posted whenever good (or bad) things happen here

BTW, a PR stating that "the 9902B is now open to all Gleason scores" is equivalent to stating that the restults of 9902A are excellent and that the company believes that an approval is likely - if you see this PR - BUY DNDN immediately.

[eliteG]

DNDN lacked volume today but it put in a nice candle... def watching