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Friday, May 30, 2008

THE RALLY

On June 30th, thousands will take to the streets around the nation in an organized rally to raise awareness for cancer treatment, specifically highlighting the FDA’s questionable decision to keep Dendreon’s (DNDN) prostate cancer vaccine, Provenge, off the market last year.


As I’ve emphasized many times before, the FDA’s advisory panel of 17 declared Provenge safe by a 17-0 margin and also declared that Provenge demonstrated efficacy with a 13-4 vote. 

Indications were that the FDA would approve based on the advisory committee’s vote, in effect marking a breakthrough for cancer treatment and marking a move forward in the way the FDA approves cancer treatments, as Provenge demonstrated the ability to extend the lives of prostate cancer patients.


After the FDA denied approval of Provenge, instead chosing to wait until interim results are released from an ongoing Phase III trial, two of the doctors who voted on the Advisory Committee were found to have financial ties to a company working on a competing drug to treat prostate cancer. Questions and lawsuits followed, headed mainly by Care to Live, a non profit, patient-advocacy organization dedicated to gaining the approval of Provenge and extending the lives of cancer patients through the use of new, novel therapies such as Provenge.


Care to Live organized the rallies that will take place around the country on June 30th, and the locations and contact info are listed below.



LOCATIONS: 

Seattle, Washington — 1 PM PDT 
Westlake Park (Downtown) — 400 Pine St 
Coordinator - Jason Burdine 
jnaburdine@comcast.net 


Chicago, Illinois — 3 PM CDT 
ASCO / McCormick Place — 2301 S. Lake Shore Drive 
Coordinator - Sean Morgan - 
morgan2174@yahoo.com 
Co-coordinator - Arnie Mass - 
Ammass14@aol.com 


Cleveland, Ohio — 4 PM EDT 
Public Square outside terminal tower — downtown 
Coordinator - Kerry Donahue - 
bedonwahoo@aol.com 
Co-coordinator - Mike Bauman - 
jmb15mjb4@gmail.com 


Dearborn, Michigan — 3 PM EDT 
Rep. John Dingell’s Office — 19855 West Outer Drive — Suite 103-E 
Coordinator - Gregg Burch - 
ctl-dearborn-rally@live.com 


Madison, Wisconsin — 4 PM CDT 
Wisconsin State Capitol Building — 2 East Main Street 
Coordinator - Melody Davis - 
MDavis@caretolive.com 


Tampa, Florida — 3 PM EDT 
H. Lee Moffitt Cancer Center & Research Institute 
University of South Florida 
12902 Magnolia Drive 
Coordinator - Ardeis Scott, MD - 
ardeisfka@aol.com 


Philadelphia, Pennsylvania — 2 PM EDT 
2 PM Assemble and pass out flyers at 12th & Market Street for march to FDA at 
4 PM — 200 Chestnut Street U.S. Customhouse Building 
Coordinator - Mike Kearney - 
publicrelations@caretolive.com 
Co-coordinator- Rory Kearney - 
rk@caretolive.com 


New York, NY — 9 AM ESDT 
Memorial Sloan-Kettering Cancer Center — 1275 York Avenue 
Co-Coordinators - Leslie Mulkey - 
lhrmulkey@aol.com 
Kevin Ward - 
kward3@nyc.rr.com 


Atlanta, Georgia — 3 PM EDT 
Atlanta FDA Regional Office — 60 Eighth St. N.E. 
Coordinator- Bob Madden - 
rjmcanoe@aol.com 

For more information go to 
www.CareToLive.com 

Epicept (EPCT) Moving Up

Not too long ago, Epicept (EPCT) was trading in the mid-thirties following the EMEA’s negative trend vote regarding the company’s New Drug Application for approval to market Ceplene, the company’s treatment for recurrent AML, in Europe.


With six drugs total in the Epicept pipeline, I saw that drop as a chance to buy some more shares. I couldn’t see the stock trading that low for too long. The company stated they would appeal the Ceplene vote, and it would only be a matter of time before we started seeing updates for their ongoing clinical trials.


A little over a year ago, the share price jumped to over four bucks on an Azixa update, Epicept’s drug for the treatment of metastatic brain cancer, so thirty-something cents seemed like a great bargain to me.


Earlier this week the company issued a Press Release stating that they have formally requested a review of the Ceplene application in Europe, and although forward-looking statements mean nothing in these cases, the tone of the release sounded positive, as if the company may have been able to change a few negative opinions to positive ones since the last trend vote. Investor confidence did not appear to be so positive, however, as the release was only good for a six cent jump in price.


Then came another release stating that Epicept will release results from the Phase I trial for EPC2407, the company’s drug for the treatment of cancers with advanced solid tumors or melanoma. The results appear to be positive and will be presented Meeting of the American Society for Clinical Oncology (ASCO), taking place May 30 to June 3, 2008 in Chicago.


That was good for a jump to the mid-fifty cent range.


I still see EPCT as a great buy at these levels, and i’ll keep adding, awaiting updates on the clinical trials and a possible re-thinking of the Ceplene trend vote by the EMEA.


Thirty seven cents was a steal, but anything under a buck is a great buy for a company with six drug candidates in the pipeline.


VFC is buying EPCT.


Monday, May 19, 2008

DNDN, Care to Live Nationwide Protest

Many of us get involved in the fight against cancer in any way we can, mainly by partaking in fundraisers. 


On May 30th, Care to Live, a non-profit organization that is currently in a legal battle with the FDA regarding the FDA's decision to NOT approve Provenge last year, is holding a nationwide protest to call attention to Provenge and other cancer 'vaccines' that are currently facing approval resistance by the FDA. 


I’ve discussed the issues of the new cancer vaccines on both vfcsstockhouse.blogspot.com and vfcsnewshouse.blogspot.com.


These new immunotherapies have demonstrated the potential to extend the lives of late-stage cancer patients, and Provenge, in particular, recieved approval recommendation by the FDA's advisory committee, who voted 17-0 that Provenge was safe and 13-4 that it demonstrated efficacy in clinical trial.  The FDA delayed approval.  Two doctors on the panel who voted AGAINST approval were found to have financial interests in companies that were developing their own competing products to Provenge.

 As I’ve described on the blogs, I'm fully behind the belief that we are on the verge of big things in the form of cancer treatment, and these immunotherapies are just a start. 


Russia recently became the first country in the world to approve a cancer vaccine by approving Oncophage, a treatment for kidney cancer made by a small biotech called Antigenics. As these developing economies look to bring in foreign dollars, they may decide to lead the world in approving these treatments, leaving the US, the FDA and most importantly our cancer patients, left without these treatments that have demonstrated, at the very least, the ability to extend life for the terminally ill. 

 

Below are the locations where Care to Live will gather.  They're not asking for money, just your time.  If I was in the area, I’d be there myself. After being initially drawn to DNDN as an investment, I found the cause behind that investment.


Patients lives and fighting cancer are more important than a profitable stock, but I have the impression that individuals tied to big Pharma and the FDA have monetary interests that conflict with those of the patients.


Care to Live is one organization out there that’s taking a stand. We all need to take a stand against cancer, and I applaud all those that do.


If you can make, please take part in the events of May 30th at the following locations:



LOCATIONS:



Seattle, Washington — 1 PM PDT 


Westlake Park (Downtown) — 400 Pine St

Coordinator - Jason Burdine jnaburdine@comcast.net 






Chicago, Illinois — 3 PM CDT 



ASCO / McCormick Place — 2301 S. Lake Shore Drive 



Coordinator - Sean Morgan - morgan2174@yahoo.com

 

Co-coordinator - Arnie Mass - Ammass14@aol.com 







Cleveland, Ohio — 4 PM EDT 



Public Square outside terminal tower — downtown 



Coordinator - Kerry Donahue - bedonwahoo@aol.com 



Co-coordinator - Mike Bauman - jmb15mjb4@gmail.com 






Dearborn, Michigan — 3 PM EDT 



Rep. John Dingell’s Office — 19855 West Outer Drive — Suite 103-E 



Coordinator - Gregg Burch - ctl-dearborn-rally@live.com 






Madison, Wisconsin — 4 PM CDT 



Wisconsin State Capitol Building — 2 East Main Street 



Coordinator - Melody Davis - MDavis@caretolive.com 






Tampa, Florida — 3 PM EDT 



H. Lee Moffitt Cancer Center & Research Institute 



University of South Florida 



12902 Magnolia Drive 



Coordinator - Ardeis Scott, MD - ardeisfka@aol.com 






Philadelphia, Pennsylvania — 2 PM EDT 



2 PM Assemble and pass out flyers at 12th & Market Street for march to FDA at 



4 PM — 200 Chestnut Street U.S. Customhouse Building 



Coordinator - Mike Kearney - publicrelations@caretolive.com 



Co-coordinator- Rory Kearney - rk@caretolive.com 






New York, NY — 9 AM ESDT 



Memorial Sloan-Kettering Cancer Center — 1275 York Avenue 



Co-Coordinators - Leslie Mulkey - lhrmulkey@aol.com 



Kevin Ward - kward3@nyc.rr.com 






Atlanta, Georgia — 3 PM EDT 



Atlanta FDA Regional Office — 60 Eighth St. N.E. 



Coordinator- Bob Madden - rjmcanoe@aol.com


Saturday, May 17, 2008

What Happens After a Cramer Pump, CPST?

I’ve spent some time talking about CPST, the green stock I chose for my portfolio.

The stock is up nearly 300% from the level where I first started buying it, but I’ve been buying all the way up, so I’m averaged in at close to $2.00. Not too bad, I don’t think.

After consistently setting 52 week highs lately, the stock was due for some profit taking, in my opinion, so I was waiting on the dips below three again before I started adding more shares.

Tonight, Jim Cramer’s, on his Mad Money Lightning Round, gave the stock a mention as a nice speculative stock. I’m not in a location where I can watch the show myself, but from reading the CNBC transcripts, he stated that the stock has gone up a lot, “but I like it.” In pure Cramer fashion, that kinda puts him on both sides of the fence. By saying it has gone up a lot, he has an out because that means it’s due to retreat. By saying he likes it, that means buy. So whether the stock rises or tanks, Cramer was right. Ain’t he a genious how he played that?

Truth is, who cares what Cramer thinks at this point. Once you do your homework, you can make the informed decision whether you want to buy or not, you shouldn’t rely on Cramer to make you a puppet.

I’ve read his books, and those books got me started on trading, especially trading option contracts, so I appreciate his ability to explain stock trading to the not so smart people like myself. I also remember from his book that you should never buy a stock he pumps right after he gives it a mention because after an initial spike, it will drop and you should get in after the drop.

After closing today at $3.48, CPST reached $3.70 at points in the after hours, and will probably push that high, if not higher upon opening bell on Monday.

The Cramer spike will surely bring in the traders that will play off the spike for a quick profit, and then bring in the short traders that will short at the highs and wait for the and then profit from the drop.

I expect some volatility during the next week due to the new interest in CPST.

I may even sell some profit on the spike upwards myself, if it approaches five I definitely will, as CPST will surely retreat after the Cramer pump.

I am staying long on CPST, because, at least for the time being, I believe the Capstone microturbines are a more practical solution to windmills and solar, at least for the time being.

I’d like to find a nice solar stock, too, anyone have any suggestions?

Many people are not ready to see windmills dotting the terrain, especially along the coast of Southern California where the rich want to keep their beachfront views windmill-free. Clean energy only matters to people as long as it doesn’t interfere with their vanity, and unfortunately windmills and black panels do just that.

I believe that solar and wind power will gain some widespread use further down the road, but for the time being I see Capstone’s microturbines as a growth engine for the environmentally conscious.

The positive thing about the Cramer mention is that new investors will take a position in the company, if they like what they see. So no doubt this will help us in the long run.

The only downside to a Cramer mention is that it also attracts traders, to include the short traders. That’ll give us some volatility in the near term.

I’ll take a chance to pull some profits if we approach five, which I don’t foresee anytime real soon, but more than likely I’ll add to my position when the stock retreats after the initial ‘Cramer’ spike.

TradeKing BlueShine 336x280

Friday, May 16, 2008

For 37 Cents You Get a Share of Epicept, EPCT

I’ve always like Epicept (EPCT) because it’s a small bio-tech with multiple drug candidates in the pipeline.  I’ve emphasized the benefits of investing in companies that are not ‘one-trick-ponies’, meaning they have multiple drugs to fall back on in the event that one fails or is rejected by the FDA, or in this case, the EMEA.  


In the case of Epicept, their lead drug candidate, Ceplene, received a negative trend vote from the EMEA regarding the approval to market the drug in the European Union.  Ceplene is a drug designed to treat patients with Acute Myeloid Leukemia (AML) in first remission.  The company has formally requested that the agency re-examine the opinion through an appeal process, and this should take place in Q3, 2008.


Following the negative trend vote, the stock price began to sink, and I’ll admit, it’s sank to a level I didn’t think it would reach, but there are good reasons the stock is trading so low, and in my opinion, the risk-reward buying here is better than ever.


Epicept is short of cash, in a big way.  They have stated that they have enough cash to last them through June of 2008.  For these small biotechs, cash on hand is a big consideration for investors.  When these companies need to raise cash, it usually comes at the expense of the share price in terms of large-scale dilution.  In Epicept’s case, they want to increase the amount of outstanding shares to 180,000,000.  That’s a lot of shares and a lot of dilution.


Another item putting downward pressure on the stock is the fact that many shareholders are unhappy with management.  A company could have the most promising new drug in the world, but if the shareholders don’t have the confidence that the current management team will be able to bring that drug to market, that feeling will reflect in the stock price.


The above items are both bad news for EPCT investors right now, but I originally got into EPCT for the pipeline, and the pipeline is one thing that has not changed.  Aside from Ceplene’s mis-step with the EMEA, there are five other drugs in the pipeline, the most intriguing to me being Azixa, their drug to treat Metastatic Brain Cancer.  Early last year, the EPCT stock was lifted to over four bucks based on an Azixa Phase II update.


Dilution is coming and there is some shareholder discontent, but the pipeline remains the same, so I still feel confident in the risk-reward of EPCT, especially when I have the opportunity to play this in the thirty cent range.


While I’ll still be adding shares in this low trading range, there is always the chance that a larger pharmaceutical will snatch up the company at these depressed price.  When Encycive Pharmaceuticals (ENCY) ran into their problems after receiving a third approvable letter by the FDA for their drug Thelin, the stock traded down to the below-a-buck range before being bought out by Pfizer for $2.35. 

I’m not too confident that Epicept will be bought out, but I am still confident there is a good chance I’ll get a return on value, especially when I can by at this low level.  


Many traders and investors don’t have the patience to sit on a stock like this for a few years, but in some cases I think doing just that could pay huge dividends in the end, and I’ll be accumulating EPCT as long as it stays at this low level.


VFC is all about risk-reward, and I smell good risk-reward with EPCT trading for under a buck. 


It’s Been a While for a Celsius update, but CSUH.OB is Still a Buy

Over the course of the past few months, Celsius (CSUH.OB) has been trading for below ten cents. I took this opportunity, and still do take the opportunity, to scoop up shares at nine cents. The temptation is just too great.



While Celsius is taking the time to build a business, and build distribution, it’s slow to show big results on the bottom line because of a lack of nation-wide advertising. On that note, however, the company is playing it smart and slowly building a nation-wide distribution network, and not throwing large sums of money that the company does not have into large-scale advertising.



One thing the company has done is delve into the international market. The Middle East deal that shipped 800,000 cans of Celsius to an international distributor could pay off big, even though the company had to give out shares as part of the deal.



The good thing is that the distributor will now be more inclined to make sure the product sells since they have an ownership stake in the company.



The only detriment to the Middle East deal is that Lebanon was the key recipient of the Celsius product, and Lebanon is on the verge of Civil War right now. It’s tough to think about someone running to the corner store for a can of Celsius when the bullets and mortars are flying along the way.



Celsius is also available at pharmacies in Chile. These international deals could be the difference between the company making it, as opposed to the company sinking. The US market quickly gets loaded with imitations and re-makes of a specific genre, but the clinical studies that Celsius undertook give it the edge in the international market.



Jorge Hane still hasn’t given us any indication of how he will market the product, and right now he is an unknown wild card, because Hane already has a large international distribution network in effect. It’d be nice to see Celsius taking advantage of the Hane name and distribution network.



While Celsius doubled revenue last quarter, they’re still losing money and still need financing. That fact alone is enough to keep the stock price around ten cents for the foreseeable future.



VFC is in the mindset that this company is slowly building a reliable, national and international business and that we will reap the rewards of patience when the stock price starts to pay us back.



Many insiders are in at the ten cent or above level, and that’s an indicator to me that these guys are pretty confident that they can make this business work.



Meanwhile, distribution in our own country grows, as well as the distribution overseas. We’ll keep adding revenue quarter after quarter in a nice growth-style fashion, and the little investors like me with the patience to wait this one out should be well rewarded in the end.



VFC loves the CSUH.OB risk-reward, especially at the ten cent level.

Thursday, May 15, 2008

DNDN in the News Again

With the recent rise of CEGE, due to its partnership with Takeda, it’s easy to overlook Dendreon (DNDN) and the fact that they should be releasing interim Phase III results for their Provenge trial, which could lead to approval if the results show an extended survival rate for the prostate cancer patients.

I’m pretty heavily loaded in Dendreon Jan 2009 options, which I gobbled up after the big drop last May with some of the profits I took after the big runup last march. If results are positive, however, it’ll be a nice payday, but at this point I’m leaning towards not expecting too much, so I’ll probably start selling those options on any spikes we get beforehand.

On that note, some more attention will be drawn to Dendreon and Provenge on May 30th when Care To Live will organize a multi-state protest against the FDA’s decision to not approve Provenge last year, after their very own advisory panel recommended approval.

The panel voted 17-0 that Provenge was safe and 13-4 that Provenge was effective.

When the FDA decided not to approve at that point, many prostate cancer patients, and patient activists, lobbied against that decision, and continue to do so now. Two doctors that were on the panel were charged with conflicts-of-interests, since some of their financial investments were tied to a company with a competing prostate cancer drug.

Now it’s a waiting game, waiting on the interim results of the current trial. Dendreon CEO re-affirmed his pledge to release the news in second half 2008, but did not get any more specific than that.

The only other mover for the stock price would be news of a partnership or to a lesser extent, news of a New Drug Application in Europe, or even Russia, where Antigenics received approval for their own cancer ‘vaccine’ Oncophage last month.

Dendreon, at this point, is a short-term hit-or-miss. The stock price depends on the outcome of the interim results. I still like the risk-reward, because as we saw last year, the payoff could be huge. On the other side, the stock will sink on negative interim results and the wait for final results could take up to two years. I do believe that Provenge will eventually be approved, as I believe the FDA and the rest of the world will start accepting these cancer vaccines as standard treatment, especially for those with late-stage cancers that are not able to be effectively treated with chemo and the likes.

I also believe, as I’ve previously stated, that we are on the verge of some big things in the form of cancer treatment, and these vaccines are just a start.

In the meantime, I’ll sell some of my call options on any significant rise in price, and I’ll buy some more of the stock on any significant dips, but investing here is not for the faint of heart.

Gotta have some cajones to go with DNDN right now, but if you hit, you’ll hit big.

Championcatalog.com (Hanesbrands Inc.)

The Wine Messenger

Wednesday, May 14, 2008

Capstone Turbine (CPST), What a Good Deal

Capstone Turbine (CPST) has reached surprising highs in a down market lately, trading from roughly a buck up to approx $3.50 in the past ten months.

As I’ve previously discussed, Capstone Turbine is the world’s leading producer of low-emission Microturbine systems, and over the course of the last year, the business has been growing and they’ve been landing many new contracts.

Just this past Monday, Merriman Curhan Ford initiated coverage on CPST with a ‘Buy’ rating, causing the stock to trade up nicely, launching it to the mid-three level after it had been trading under three for some time.

In previous posts, I’ve detailed many of the new orders that Capstone has received for it’s microturbine systems, and these new orders indicate great future growth for the company.

Ordinarily VFC would take his near 300% profit off the table and go home happy, but I like the future prospects of this company enough that I’ll still be adding on the dips.

When I first began purchasing shares of CPST, I had a long term outlook and, in retrospect, I did not add as quickly as I should have. I’m paying for that now, quite figuratively, but I still feel there’ll be plenty of upside in this stock over the course of the next few years.

I’m thinking that the path towards Capstone’s microturbines is a more practical alternative to other sources of green power, and judging by the contracts the company signed recently, some of the big boys agree.

The way I see it, getting the majority of my position down in the $1.00-$1.40 level makes me feel like I got in on the ground floor, and VFC likes getting in on the ground floor.

The new analyst coverage helps, but it’s the future growth of Capstone that I like. The stock that I initially bought because I was looking for something green in my portfolio (green meaning environmentally green), also just happens to be adding a lot of green to the brokerage account.

I’ll be buying CPST on the dips and holding for a while.

Wednesday, May 7, 2008

VNDA Hovering in Mid-Fives

After a nice run-up recently by VNDA, from sub-three to near six, the stock is hovering in the mid to low fives.

After the strong-volumed run-up in short time, it was expected that we’d see some profit taking and some price retracement, but I’m still holding for the upcoming FDA decision on Iloperidone. If the stock happens to approach the mid-teens before that decision, I may rethink my strategy, but I got in on VNDA (for the second time) when it dropped into the three dollar range strictly for the Iloperidone play, which I think has a better than average chance of approval.

Titan Pharmaceuticals (TTP) has also ran-up lately, and TTP is my preferred choice in the Iloperidone play, since Titan also has Probuphine and Spheramine results due out in Q3.

I like the drug company that has more than one trick and if the FDA does not choose to approve Iloperidone, Titan’s stock could still do very well this year with a positive announcement regarding Probuphine Phase III results or Spheramine Phase II.

For VNDA, after the shorts killed the stock over the past year, I believe this recent run-up is just as much a short squeeze as it is the big boys loading up for some positive news. Initially, I thought the run-up was strictly a short squeeze (after all, shorts made a killing shorting VNDA this year), but after it leveled off in the five dollar range, I think the institutions and the big boys are loading up in anticipation of the FDA’s decision.

Many large institutions and funds don’t play with stocks under five bucks, but after the run-up, the five dollar benchmark is not a concern. They’re free to accumulate.

I’m also wondering if some insiders got tipped off to positive news in the works, whether it be a positive FDA decision or a partnership deal by the company, that may have launched the run-up. There are strict laws regarding insider trading, but we all know that money talks and BS walks in the securities business, unless you’re Martha Stewart.

Vanda also released a compilation of positive information regarding Iloperidone’s safety and efficacy in various Phase III trials, but that alone should not be enough to warrant an almost instant three dollar increase in share price, although I believe it may have gotten quite a few shorts to cover just in case the FDA does approve.

That, coupled with the big boys wanting in, would be enough to start a run-up.

I think we’ll trade in the five dollar range for a week or so more before the stock ticks higher leading up to the July FDA decision. On a positive decision I see us in the mid twenties, on a negative decision, just forget about it. I don’t have enough faith in Vanda’s sleep drugs to stick around.

For TTP, which I feel is the safer and smarter play, I see us around four on positive Iloperidone results, much higher if Probuphine and Spheramine pan out.

I’m at a HOLD level with Vanda right now, but I’m still adding TTP.

Just sittin back waitin on the FDA decision.

Sunday, May 4, 2008

Vanda (VNDA) and Titan (TTP) are Looking Good

I’ve spent a lot of time describing my interest in Titan Pharmaceuticals (TTP) and spent a little less time on Vanda Pharmaceuticals (VNDA). Vanda and Titan both did me good in December of 2006 when Vanda announced positive Phase III results for it’s schizophrenia drug Iloperidone, also known as Fanapta. Shares of Vanda rose to the low to mid 20 dollar level and Titan, who will receive approximately 10% of Fanapta revenue due to licensing deals, rose to the mid-three dollar level. I sold all of my Vanda and most of my Titan at that point, enjoying the large chunk of stock winnings to pay off some bills.

After that jump in stock price, both VNDA and TTP started to retreat pretty quickly. Titan actually dropped to under a buck for a short time (a great time to load up) and VNDA was under three for a time. I took the opportunity to buy shares of both companies as the prices dropped, but I believe Titan is the better investment due to their advanced, late-staged pipeline including Probuphine and Spheramine. I’m averaged in Titan at around the $1.55 level and Vanda right around the five dollar mark.

VNDA wasn’t quite worth the risk to me above the ten dollar mark, but TTP is worth the risk, in my opinion anywhere below five, especially with all the news pending.

In the case of Titan, three huge pieces of news could propel the stock higher this year, including the Fanapta FDA approval, Probuphine Phase III results and Spheramine Phase II results. Add to that the possibility of a buyout and TTP could be a big winner.

Big Pharma is out looking to boost their pipelines, and Titan would be a great candidate due to their pipeline and ties to Bayer-Schering.

I also believe it’s a positive that former Titan CEO and founder Dr. Louis R. Bucalo recently retired from the company. The company needed to wash it’s hands of Bucalo’s shady stock dealings of the past (see previous TTP posts). I’m sure he’ll still benefit from any Titan success, but his name is no longer tied to the company.

Vanda also has an insomnia drug in it’s back pocket to go along with Iloperidone, but the market is too saturated with sleep aids to get me really excited about that. Investing in VNDA is, in my opinion, strictly an Iloperidone approval play, and a play that looked too good to pass up when VNDA was trading at the three dollar level. As I often state, I like the good risk-reward profile and at the two-three-four dollar level, I think Vanda is worth the risk because at those levels, approval will reap very good rewards.

Vanda has also recently drawn some analyst coverage which place the Vanda price target between $16 and $22. This, of course, is with FDA approval of Iloperidone. VNDA is listed as a Buy, nonetheless, by Friedman, Billings, Ramsey & Co. analyst David Amsellem (a reiteration) and Caris & Co. analyst David Moskowitz recently initated coverage at ‘Buy’.

It was fun to watch the market manipulate the Vanda stock down to this low level as many columnists with admitted ties to entities who where short the VNDA stock, bashed and bashed Vanda down so their buddies could make money. It wasn’t hard to guess that once the stock got bashed down, some of the analysts would jump on the ‘Buy’ bandwagon and start supporting Vanda.

After all, the shorts have to cover at these low levels and the stock is sure to go up when they cover, and the covering has already started.

The FDA’s decision on Iloperidone should be out in July, and in the meantime we can sit back and wait, maybe accumulate some more (I will accumulate some more VNDA, but I prefer to accumulate TTP) and wait for the news. If the news is good, VFC doesn’t see any reason why Vanda won’t approach it’s mid-twenties level that we got after positive results were released in December, 2006

Once this news is out of the way, we can sit back and wait on some good news regarding TTP. TTP may approach, in my opinion, eight to ten bucks with positive news on all three pending events.

It could be a good year for those invested in VNDA and TTP.

VFC’s Long Term Cancer Pick, Cel-Sci Corp (CVM)

To go along with all the nearer-term cancer immunotherapy products such as CEGE’s GVAX and DNDN’s Provenge, I’ve got a longer-term pick in Cel-Sci Corp (CVM). I’ve slowly but surely been accumulating this one over the past year or so.

Since it’s currently still trading in the .60s (that’s cents) it’s pretty easy to accumulate quite a few shares, and CVM goes in line with my risk-reward mentality. Buying at this price, the risk is relatively none, but if Cel-Sci’s lead product, Multikine, makes it to market, the rewards should soar us upwards, as Multikine could rake in over a billion dollars a year in sales.

Multikine, according to the Cel-Sci website, is the first immunotherapeutic agent being developed as a first-line standard of care cancer treatment. Multikine is also a different kind of weapon in the fight against cancer; one that harnesses our body’s natural ability to fight tumors.

This all sounds familiar to the other cancer immunotherapies in clinical trials, but Multikine is being developed as a first-line standard of care treatment for cancer.

Currently, Cel-Sci is preparing for an 800 patient Phase III trial for the treatment of head and neck cancer. After coming to market, it’s safe to assume Multikine will be tried and tested to treat other types of cancer, giving it the potential to pull in billions.

Phase II trials demonstrated that Multikine is safe and possibly efficacious and the FDA cleared Cel-Sci to begin Phase III trials, which should begin in Quarter 3 of this year. Multikine was also granted Orphan Drug designation in the US.

To prepare for the manufacture of Multikine for the Phase III trial, and eventual commercial sale, Cel-Sci is building a manufacturing facility built near Baltimore, MD.

Multikine was featured in the February 2008 issue of MedAdNews where it was listed as one of ten predicted future blockbusters by the publication. The article can be accessed via the Cel-Sci website at: http://www.cel-sci.com/media_7.html.

CVM is not one for the impatient investor or quick trader, but I’ve got a few years to sit on this one and see how it develops. For the price of a few beers a day, it’s easy to accumulate shares and the payoff could be huge.

If all goes south, then I don’t figure I’d lost too much since I don’t really need those beers anyway.

Again, if you’re patient enough to sit this one out, VFC likes CVM.

Nice Surprise from Cell Genesys (CEGE) This Week

I’ve got to say, it was a pleasant surprise to see CEGE close the day at $4.53 on Friday and that my Jan 2009 $5.00 strike calls closed at a buck ten.

While Cell Genesys’ prostate cancer vaccine, GVAX, offers promising hope for the future, I always counted on Dendreon(DNDN) bringing Provenge, it’s own prostate cancer treatment, to market first, and I had big things in mind for CEGE about a year later.

Dendreon has the immediate upper hand if the FDA accepts mid-term results on their ongoing Phase III trial for Provenge and approves the drug later this year, but CEGE is not too far behind with GVAX.

Cell Genesys and it’s shareholders got great news recently when a partnership with Takeda Pharmaceutical Company of Japan was announced, giving Cell Genesys a huge financial backer and marketing partner. That was enough to kick off a nice uptrend in the stock and maybe start a little bit of a short squeeze.

More good news came on Friday when CEGE beat expectations with it’s earnings, losing only 29 cents a share vice the 42 cents that the street predicted.

The 16% jump in price Friday came with twice the average volume, always a good sign when a stock jumps on high volume.

It’s tough to tell whether or not there will be some profit taking and a little retreat in price, but I’m holding on this one and will buy more on the dips.

I’m also hanging onto those Jan 2009 calls for a bit longer. It’s nice to see them close at $1.10, already more than a double for me (although still unrealized).

As the clock ticks towards the Provenge mid-term results that may be enough to gain FDA approval for the drug, DNDN and CEGE should be interesting plays in the coming year.

Since DNDN interim results are due out this year, I’m more heavily invested in Dendreon than Cell Genesys right now, something I’m not entirely comfortable with, so I may sell down some DNDN on the spikes to even it out. If the news is good, DNDN will soar anyway, but if the news is bad, down we go. A lot of my DNDN investment is also in the Jan 2009 calls, so I’d rather sell those and go more long term by buying stock, just in case we need to wait on final results vice interim.

It’s only a matter of time before the FDA changes it’s thinking regarding cancer immunotherapies such as GVAX and Provenge, and it’s more and more likely that these companies will also apply for overseas approval in conjunction with US approval applications, especially after Russia’s decision to approve Antigenics’ cancer immunotherapy Oncophage.

As I’ve made known, I enjoy investing in small biotechs that are developing these immunotherapy treatments for cancer because when one hits, as demonstrated by the DNDN rise last year on a positive advisory panel decision, they hit big.

I also believe we’re on the verge of big things in the way we treat cancer, and most importantly of all, if these immunotherapy treatments can help the cancer patients live longer or even survive the cancer completely, then they need to be made available.

VFC likes CEGE and DNDN for the next year or so.

Sirius/XM Merger, This Makes Sense

I’ve never been accused of being too smart, but one thing is starting to make sense to me about why there is so much vehement opposition to the Sirius/XM merger, especially by the NAB and those politicians that are heavily ‘subsidized’ by the NAB.

Where satellite radio is heading could change the landscape of the way people listen to radio, possibly rendering terrestrial radio irrelevant.

According to a recent patent, it looks as if SatRad will be offered FREE in all vehicles equipped with a SatRad receiver. The catch is, the free service will have advertisements. A subscriber-based service will continue to offer commercial-free channels and premium content.

Looking at it from this perspective, I now understand why terrestrial radio is fighting this merger. The SatRad signal is much clearer and void of interference than the terrestrial signal, and the signal will stay with you wherever you drive around the country.

And now that it will be offered free, there is there is a lot better chance that the average driver will listen to the superior SatRad programming lineup and superior signal quality, effectively drawing in advertising revenue and growing a larger subscriber base.

The SatRad companies will then enjoy increased advertisers that will pay to advertise on their free stations, and then SatRad could advertise itself for free; Once the listener is tuned into to the free programming, advertisements geared toward their premium content are sure to lure people into paying for the subscriber service.

I like this plan, and I’m more confident in my SIRI investment today than I was yesterday, although I was pretty confident in the long term outlook of SIRI anyway, especially post-merger.

I still anticipate merger news is remarkably close, and I still anticipate the FCC will allow the merger to pass, as did the DOJ recently.

Even with the new ability to merge advertisements into a free broadcast while leaving the premium content commercial-free, the SatRad company(ies) are still competing with technology such as iPods, iPhones, Cellphones and MP-3 players, among other items.

By no means will this new technology eliminate SatRad’s competition, but it sure does make it the best choice for the radio-listener.

Once this plan is on-line, the SatRad advertising revenue stream and subscriber base revenue stream should both grow substantially.

VFC is predicting exciting things ahead for SatRad, and I’m glad to be a part of it.

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