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Sunday, November 23, 2008

OFF TOPIC: But Worth It, The Sniffle Sleeve

An old friend of mine launched a novel and new product that VFC believes is long overdue.

I'm more than happy to advertise this great innovation on my website. The sniffle sleeve is so simple, yet so innovative, that you wonder how we've been missing this idea until now.

I've cut and pasted Wendy's email to her fans, and friends (even though we disagree on the proper employment of room fans), and please take advantage of her superb product!

www.snifflesleeve.com

Some of you are aware that I've been playing with a new business idea for the last year or so called a Sniffle Sleeve. For those who haven't heard anything at all, I've made, patented, trademarked and just finished my first phase of production for a small, very simple children's product, the aforementioned Sniffle Sleeve.

I won't launch into a long explanation, I'll just say that it's an educational tool for children to learn more easily to cough and sneeze into their elbow instead of their hands. The CDC and the American Pediatric Association have made a big push in the last two years to try and train children, and retrain adults, on this new policy.

What I'm hoping you can do for me is read through my newly launched website, give me any feedback you are willing to share and if you know of a store or children's boutique you think would be interested in carrying the sleeve, to pass me their name. My website is:
www.snifflesleeve.com


A very funny video on this policy is:
Why Don't We Do It In Our Sleeves?

Monday, November 10, 2008

VFC's Stock Pick Update; INSM, Insmed's IPLEX is Back in Action; SIRI, Sirius Reports Third Quarter Results

INSM, Insmed Incorporated:

Previous Insmed Posts:
VFC's Follow-on Biologics Pick, INSM
INSM: Signs of Life
Insmed Update
VFC's Bear Market Picks, AGEN, MVL, INSM, CSUH.OB

I've previously discussed Insmed as a great long term pick because of this small biopharmaceutical company's cancer treatment and follow-on biologics pipeline; not to mention it's ownership of the already FDA approved IPLEX, which is currently in experimental trials for the treatment of various conditions.

A couple of years ago, Insmed lost a patent case (read about it here) which sent it's share price tumbling to below a dollar and it hasn't recovered since. In fact, the latest economic turmoil sent the stock price to near thirty cents, a price where smart investors were loading up for the future (in VFC's opinion).

VFC's Brief Review:
What are Follow-On Biologics?
Follow-on biologics are versions of approved biologics that are developed after the original product has been created with the intention of marketing them after the patent on the innovator product has expired, thus bringing competition to monopolistic markets. In other words, when the patents on current drugs expire, other companies can step in with their own, possibly cheaper, products to create competition in the drug market.


IPLEX- Almost two years ago, Insmed lost a patent-violation court case where it was argued that Insmed’s drug Iplex violated Tercica’s patent for it’s similar drug, Increlex. Both drugs were administered as insulin-like growth factor for short-statured patients, but Insmed’s drug, Iplex, is the superior drug. Iplex only needs to be injected once a day while Tercica’s drug, Increlex, is a twice a day shot. Insmed is also currently conducting various-phased trials for Iplex treatments for other indications, such as ALS, HIV and MMD. Eventually, Iplex itself has the potential for blockbuster status, although some of that money will be dished out to Tercica thanks to the patent infringement case.

Today, Insmed released great news regarding IPLEX. In a joint release, Genentech, Ipsen/Tercica and Insmed announced that in an amendment to the previously-mentioned court agreement, Insmed will be permitted to supply IPLEX in connection with named-patient ALS programs worldwide on a royalty-free basis. This amendment is in response to the expressed desire of ALS patients to receive IPLEX for the treatment of their indication.

Although IPLEX is not yet approved for the treatment of ALS, it's been used in that capacity in Italy for a while now, and the results from Italy could be used to show efficacy for future approval.

According to today's Press Release, Ipsen/Tercica may jump on board the IPLEX bandwagon and partner with Insmed for future commercial development and marketing of IPLEX to treat ALS.

In addition, Insmed, a leading developer of follow-on biologics, could be a benefector of the new Democratic Administration, as new follow-on biologics legislation should be on the agenda of the next Congress. Congressional attention to follow-on biologics has taken a backseat to the current economic crisis, but once the issue is re-visited, Insmed will be ahead of the game with four follow-on candidates in the pipeline.

Representatives from Insmed will be presenting at a couple of upcoming Health conferences, so it is possible that the Press Releases are just beginning, and in response, the share price could approach, if not surpass, the dollar mark in short time.

RISK:
- IPLEX, although already approved to treat Short Stature, fails to demonstrate results in other indications.
- Insmed fails to bring any of their follow-on biologic candidates to market.
- Insmed fails to bring any other pipeline drugs to market.
- Insmed fails to get the share price above a dollar and faces delistment from the NASDAQ.

REWARD:
- IPLEX begins to bring in cost-recovery revenue from it's ALS named-patient programs.
- IPLEX ultimately receives approval to treat ALS or another indication.
- Follow-on biologics partner is announced.
- Follow-on drugs are approved.
- Other drugs in the pipeline gain approval.

TIMEFRAME:
I've been slowly accumulating INSM for about two years, and the lower the stock price dropped, the more shares I bought. As long as the stock price is below a buck, I'll still be buying as much as I can and I'm ready to wait a few years for the IPLEX story to development and for the follow-on candidates to reach approval stage.
ShareBuilder - Welcome page

SIRI, Sirius XM Radio:
Shares of SIRI remail beaten down in the twenty cent range, and although revenues increased this past quarter, the 3Q results looked terrible thanks to a $4.8 billion dollar, merger related markdown.

Growth has slowed, in large part due to the failing auto industry, and until the economy picks up, sirius growth of the past cannot be expected.

Investor confidence in Sirius XM will remain downbeat until financial terms of the huge debt bill coming in 2009 are announced.

All looks bad for SIRI, doesn't it?

I believe that this company is going through it's absolute worst time right now, but once things begin to turn around, the patient investor will be rewarded. SIRI has crushed many a hopeful investor over the past year, and the FCC and DOJ have a lot to answer for that by taking 18 months to approve the merger.

Many investors have taken the loss and sold their SIRI shares, which I think is a mistake at this point. Granted, the immediate benefits of the merger went out the window with the slump in the auto industry (and consequently, the slump in SIRI XM growth), but once the Politicians quit telling the country that we are in a Great Depression and people start feeling positive again, money will flow back into the economy, jobs will be created, people will again be buying cars and subscriptions, and SIRI XM will have announced terms of their debt refinancing.

Our economy is not finished, and neither is SIRI XM.

Unless you're a trader looking for a quick buck, It's worth holding, and even adding shares of SIRI, to wait and see what this company brings in the next year.

RISK:
- SIRI XM cannot refinance their immediate debt at resonable terms.
- SatRad loses steam and as a result SIRI XM loses subs.
- The company never turns a profit.

REWARD:
- Re-finacing of debt is announced.
- Economy picks up, auto industry recovers and subscriber growth returns.
- Those investors buying now are rewarded down the road when the economy is turned around and debt issues are settled.

TIMEFRAME:
At least a year, but in a few years from now investors should be happy (in VFC's opinion). I've got to give Sirius (as I did with Celsius) a pass for at least this quarter and next as far as subscription growth goes, due to the weak economy. People simply are not spending money, especially on luxury items such as SatRad. Once the debt issue becomes clear, that should boost investor confidence and as that confidence returns, the short sellers should cover. If the economy remains in a slump, and if debt terms are not announced soon, a reverse split could be a possibility.

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Friday, November 7, 2008

Quarterly Updates, CSUH.OB, EPCT

Celsius Holdings (CSUH.OB) Third Quarter Results:

Celsius released disappointing third quarter results yesterday, but my opinion on CSUH.OB as an investment has not changed. For some time, it's been my view that the next three quarters will be crucial for the company. If the company cannot demonstrate that the product is catching on and showing growth in the next three quarters, then it may be time to re-evaluate our positions in the stock. I did not expect overwhelming results for this quarter, but I did expect to see an increase in sales over last quarter, which we did not, even without taking into account the huge Lebanon order of last quarter. The product is great, it's a matter of marketing, at this point.

CEO Steve Haley reported shrinking growth this quarter. Net sales were $435,000 compared to sales of $508,000 in third quarter 2007. These results definitely do not show that the product is catching on or that re-orders are coming in. A few factors contributed to this decline in sales, including losing two distributors and switching over to new distributors in certain areas.

Now for the good news. According to Mr. Haley, Celsius sales are increasing at The Vitamin Shoppe, which is encouraging because the Vitamin Shoppe is a national chain and the biggest name retailer selling Celsius, to date. Also, Polar distributors, the nations largest independent soft drink bottler, just signed on and will distribute Celsius throughout the Northeast.

Celsius faces stiff challenges. Not only are they launching a new product in a competitive environment, but the weak economy has consumers holding onto their money and not willing to spend their money on $2 Energy drinks. In that regard, I give Celsius a pass for this quarter, and probably next. But that does not detract from the fact that someone needs to keep this company afloat (DeSantis?) before a great product goes bust due to lack of financing.

The actions of management indicate that they are confident of maintaining operations and receiving financing:

-They have recently purchased the rights to "Burn, Baby, Burn" and have began using the catchy tune in targeted radio ads.

-A new product is in the works, in addition to the previous Green Tea, non-carbonated launch, and that product should be out early next year.

-TV ads are in the works. Once those ads start rolling, that should attract solid business. Earlier in the year Mr. Haley informed us that they would hold the ads until after the elections, but in yesterday's conference call, he stated that the TV ads were still not complete. I had hoped that they could have had those ads ready to go, post-election. I know the Florida weather is nice these days, but "Chop, Chop, Guys!"

All things considered, it's time for management to kick it up a notch and bring this product to fruition. Heavy investment went into advertising this quarter, including the licensing rights to "Burn, Baby, Burn", so management is now on the clock to show results. The TV ads need to get done.

Despite the disappointing Third Quarter results, in VFC's opinion, nothing has changed moving forward. The weak economy is killing sales as much as anything else, but if the company survives a few more quarters, we could see a real turning point in sales, and in stock price.

Risk:
- Financing. No financing, no company.
- Prolonged recession would kill sales.
- Product does not catch on, despite new advertising.

Reward:
If the company survives a few more quarters, and advertising kicks in, the product could take off and the stock price will follow. Hardly a risky investment trading at under 10 cents, especially if you trade in and out to cover your risk.

Timeframe:
Will re-evaluate after three quarters.

Steve Haley Answers Some Questions

LinkShare Referral Prg

EPCT, Epicept Third Quarter Results:
Financial results for speculative biotechs mean little. As long as the management is not irresponsibly burning through money, a loss is not a big deal and highly expected.

What is important from the quarterly reports are the updates on the drug trials.

Epicept (EPCT) is still a great bargain at these prices, in VFC's Humble Opinion, since their lead drug candidate was approved for marketing in Europe last month, and the company plans it's European launch during the first quarter of 2009. The only questions remaining, are the questions of a partnership, which they also plan on finalizing early next year, if not sooner. Ceplene is almost assured to produce revenue next year, which makes 70 cents an attractive price to buy.

Epicept will also provide an update on NP-1 early next year. NP-1 is (taken from the Quarterly Report) a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies which is currently nearing completion of Phase II trials.

Updates Myriad's Azixa trials are also possible within the next year.

Risk:
- Epicept does not receive favorable terms from it's marketing partner for Ceplene in Europe.
- Ceplene does not produce expected revenue.
- Azixa and other drug candidates are unsuccessful in trials.

Reward:
- Ceplene is already approved in Europe and will almost assuredly start generating cash next year.
- Azixa or NP-1 are successful.
- This stock could double at any time.

Timeframe:
The time to be in is now. You don't want to miss the run when it happens (VFC's Opinion).
ShareBuilder - Welcome page

Monday, November 3, 2008

VFC'S Biotech Stock Updates: BVTI.OB, CEGE, CVM

BVTI.OB, Biovest International Inc:

Awaiting Phase III Results, BVTI
Why VFC Sold Out of BVTI
BVTI.OB Not Acting Like a Stock With Good News Pending
BVTI, We'll Know In September

Since selling all of my holdings of Biovest International Inc (BVTI.OB), I decided to buy back in last week after the company told us that Biovax ID will be sold under a named-patient program in France, Germany, Italy, Greece, Spain and the United Kingdom with sales expected to begin in the first quarter of 2009.
Biovax ID is Biovest's cancer immunotherapy vaccine for Non-Hodgkin's Lymphoma.

Biovest is a majority-owned subsidiary of Accentia Biopharmaceuticals (ABPI).
I'm still sceptical that BiovaxID has demonstrated enough efficacy in it's recent Phase III trial to garner approval, but this recent news indicates that there may be a future for this immunotherapy treatment. And with the stock trading at 25 cents, the risk-reward is well worth the investment, in VFC's opinion.

While this news does nothing to boost the chances of approval here in the US, it's a strong indication that the company is looking towards approval in Europe.
Antigenics (AGEN), the producer of the world's first approved cancer immunotherapy vaccine, followed a similar path; after not receiving approval in the US for it's kidney cancer immunotherapy, Oncophage, Antigenics looked to Russia for approval - and got it.

Biovest's agreement to distribute in Europe will create a revenue flow, and they'll be able to continue to build a case for approval while doing so.

Investor confidence is low, and parent company Accentia BioPharmaceuticals was delisted today and will start trading on the pink sheets beginning tomorrow. These facts, combined with the previous 'fluff' PRs put out by the company, have dropped the BVTI.OB stock price down to a level where I'm willing to buy.

BVTI.OB is still a risky play, but one that could pay off big down the road, especially if the patients that will receive Biovax in the patient-first program show improvement. The way I see it, this program will keep the company treading water until they either solidify the case for Biovax approval, or decide that Biovax doesn't work.

For a quarter, it's worth the risk, in VFC's opinion.

RISK:
- Biovest likely does not have confidence that the recent Phase III results will be enough to convince the FDA to approve. It's possible that Biovax will never be approved in the US.
- Patients receiving Biovax in Europe do not show any improvements after receiving the Biovax treatment.
- Biovax fails to be approved in Europe or anywhere else in the world.

REWARD:
- Biovax begins to see revenue from Biovax use in Europe.
- Biovax eventually receives approval in Europe, the US or both.

TIMEFRAME:
This one is risky and unpredictable. I'm looking a couple of years down the road, maybe sooner, to see how the company plays Biovax. Filings in the US and Europe are sure to come. If either one pays off, this could be the best quarter you ever spent.
ShareBuilder - Welcome page

UPDATE- CEGE, Cell Genesys:
If you didn't listen to me when I last posted about CEGE, you would have made about 80% on your money.

I still think CEGE is still too risky right now, there's no guarantee that a buyout or partnership is in the works, and while CEGE has performed terrific over the past couple of weeks, I'm not willing to risk my money there right now.

I've got a huge tolerance for risk, but not huge enough to play with CEGE right now, not with GVAX out of the picture.

RISK:
- Huge risk. No guarantee of buyout or partnership and no evidence that GVAX is worth anything at this point. In one day you could lose it all.

REWARD:
- A buyout or partnership could bring in hefty returns on your investment.
- Stock could continue upward trend on speculation.

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CVM, Cel Sci Corporation:

Since last posting about CVM, the company has announced an additional licensing agreement for Multikine, a treatment for head and neck cancer that is about to enter into Phase III trials.

Recently assuming control over the Multikine production facility near Baltimore, Marlyand, Cel Sci extended thier marketing agreement with Taiwan-based Orient Europharma Co., Ltd. ("Orient Europharma") to cover South Korea, the Philippines, Australia and New Zealand.

Already listed as a potential billion dollar blockbuster by MedAdNews, Multikine is poised to gain worldwide traction for the treatment of head and neck cancer, once approved.

I've been accumulating CVM for a little over a year now, and will continue to do so for as long as this stock is trading below a buck.

Cel Sci is a one trick pony, an investment here is an investment in Multikine. Usually I don't do one trick ponies, but I like what I've seen from Multikine, and I'll be watching the Phase III trials pretty closely.

At around thirty cents, the possible rewards well outweigh the risk, in VFC's opinion.

RISK:
- Multikine is a dud.

REWARD:
- We're in on the ground floor of a groundbreaking new cancer treatment that is poised to launch world wide on approval.

TIMEFRAME:
Years.

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MORE VFC STOCK PICKS BELOW:
VFC's Bear Market Stock Picks Part I
VFC's Bear Market Picks Part II
VFC's Bear Market Picks Part III
VFC's Bear Market Non Picks Part
VFC's Stock Updates
VFC's Bear Market Picks Part IV; CRYP, CSUH.OB
Bubbles

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