D-Day was Thursday for BioDelivery Sciences (BDSI) as the FDA finally granted approval to market and distribute Onsolis, a treatment for pain in cancer patients.
The FDA delayed issuing the Onsolis approval for over a month; a time frame that saw the BDSI stock slide from eight dollars to six. Some investors, myself included, were sceptical of the actions of the FDA and others were turned off by the large amount of insider sales after the delay was announced mid-June.
The combination of investor scepticism and insider selling took the wind out of BDSI's sails and the stock closed the day on 'approval dayl a mere 2.5% to the positive, although it did hit $7.25 at one point during afternoon trading.
Many predictions, mine included, had the stock trading as high as between $10-$12 after approval before settling into the $8-$10 range, but that was before things started to look suspect in late June.
Long term investors who hung in there waiting for a nice spike after approval were quite disappointed today, but there's no reason to worry or panic sell now because the stock will rise again; it's just a matter of time.
In fact, with the Onsolis approval now a done deal, I see BDSI as a BUY while trading for $6.
Today's recessionary market is not a normal one. The stocks of both Antigenics (AGEN) and Epicept (EPCT), for instance, both actually traded down when they received market approvals over the past year (Oncophage in Russia for AGEN and Ceplene in Europe for EPCT). There situation, in my opinion, created great buying opportunities for those who have the patience to load up low and wait. AGEN has already began to come back and I don't think there is any doubt that BDSI will, too.
There's no telling why the stock traded as it did today, we can only speculate. Those who saw the news of approval ready to hit the wires probably shorted at the $7.25 high, and it could be that some of the insiders that sold now want back in. Both scenarios would indicate that the big boys will play this stock to suit their needs until their positions are set and the real move can begin.
The small investor should not fall prey to the games of the big boys. Hold onto your shares and wait for the stock to rise. With Onsolis approved, a revenue stream is all but guaranteed- and that's on top of the $27 million milestone payment that the company will now receive.
Something that investors may find troublesome is the fact that the Onsolis approval came with some FDA restrictions in order to keep patients from overdosing or becoming addicted to the drug. Labels such as this one can scare away potential customers, and therefor hurt revenue, and some may have altered their value of potential future drug sales based on these FDA restrictions. That may be another reason why a spike to above $10 did not occur.
Additionally, investors who were counting on Michael Jackson's Doctors getting a hold of Onsolis to increase distribution will undoubtedly be disappointed with the recent heat being brought on prescription medications.
All being said, I know the price action today did not indicate it, but it is a day for shareholders of BDSI to celebrate. HOLD onto your shares. While the stock may be volatile for a little bit longer, with an FDA approved drug and a potentially blockbuster delivery system, BioDelivery is a much safer investment on Thursday than it was on Wednesday.
I did not sell today; I'm going to wait for the eventual rise in price before I sell any shares. As I've described before, I'm playing on house money with this one.
Congrats, BDSI longs.
Disclosure: VFC is long BDSI.
Thursday, July 16, 2009
Wednesday, July 15, 2009
VFC's Take on BioElectronics Corp (BIEL.pk)
In response to quite a few readers who were looking at BioElectronics Corp (BIEL.p.) over the past few weeks, here's VFC's take on BioElectronics Corp:
Are you looking for the next CSUH or TTNP? There's a good chance that BIEL will fill the bill- and there's a good chance that investors will be reaping rewards fairly soon.
Let's get the scepticism out of the way first:
- Keep in mind that anything that looks too good to be true usually is, especially in the stock market.
- BIEL is a pink sheet stock, making it a more risky investment than most.
Now let's be realistic:
In this market there are (and have been) more stocks than normal that are (or have been) trading for values that look to good to be true, only to find out that it's not an illusion- they really are that good a value. Take Titan Pharmaceuticals (TTNP), Celsius Holdings (CSUH) and Dendreon (DNDN) as just a few examples of such stocks. All three were great risk-reward stocks that paid off and BIEL is another one that can pay off big time.
I also think the fact that BIEL currently trades on the pink sheets is a positive, not a negative, for risk reward investors. Most investors view the pink sheets as too risky, which means it will fly under the radar, allowing small investors to load up on the stock for a cheap price until big news hits. Once (if) big news hits, the stock could skyrocket over 1000% (at least), as did TTNP.
The perfect storm for success could be forming for this company and it's stock.
With Acetaminophen and other over-the-counter drugs coming under recent heat by the FDA, BioElectronics technology, and therefor their products, could provide a safer and more effective alternative.
BioElectronics has taken a long used medical treatment, electro-magnetic pulse therapy, and miniaturized the entire treatment into a patch that has been demonstrated to reduce pain, swelling and increase the rate of healing. The technology is groundbreaking, in my opinion, and the potential for commercial application is even better.
According to the BioElectronics official website, the company is marketing its products in two product lines, Actipatch and RecoveryRX. The technology has already been approved by the US FDA for some plastic surgery indications and also has approvals in markets around the world for both medical and over-the-counter use.
In the United States, BioElectronics is seeking approval for many other indications, including for both medical and over-the-counter use, and as I said before, with medical narcotics and Acetaminophen coming under fire of late, things could just be heating up for BioElectronics and the Actipatch technology.
I say it often: for the cost of a night out on the town, a small investor has the opportunity to buy a nice chunk of shares of a good risk-reward stock. If it doesn't pay off, you've lost a hangover by skipping the night out. If it does pay off (see: TTNP, CSUH), however, the percentage gains could be huge.
BIEL is trading so low, in my opinion, because of the lack of significant clinical data up until this point. People always get a little bit antsy when something involves electromagnetic pulses is applied to their bodies, but as the safety data has been accumulated and is being put before the FDA for various approvals, the time may be ripe for BioElectronics.
In my opinion, someone is accumulating the stock and keeping the price in a controlled trading range- avoiding any significant spikes or dips in order to keep the stock below the radar.
The volume is growing for the BIEL stock, and the market potential for the product is huge- two things that could equal a lot of dollar signs in the future.
Don't forget to do your own DD, but I like this stock for the risk-reward potential that it holds. To answer the question of the many readers who have asked my opinion both here and on my Seeking Alpha page- VFC says take a chance on this one, nice find.
Disclosure: VFC is long BIEL.
Are you looking for the next CSUH or TTNP? There's a good chance that BIEL will fill the bill- and there's a good chance that investors will be reaping rewards fairly soon.
Let's get the scepticism out of the way first:
- Keep in mind that anything that looks too good to be true usually is, especially in the stock market.
- BIEL is a pink sheet stock, making it a more risky investment than most.
Now let's be realistic:
In this market there are (and have been) more stocks than normal that are (or have been) trading for values that look to good to be true, only to find out that it's not an illusion- they really are that good a value. Take Titan Pharmaceuticals (TTNP), Celsius Holdings (CSUH) and Dendreon (DNDN) as just a few examples of such stocks. All three were great risk-reward stocks that paid off and BIEL is another one that can pay off big time.
I also think the fact that BIEL currently trades on the pink sheets is a positive, not a negative, for risk reward investors. Most investors view the pink sheets as too risky, which means it will fly under the radar, allowing small investors to load up on the stock for a cheap price until big news hits. Once (if) big news hits, the stock could skyrocket over 1000% (at least), as did TTNP.
The perfect storm for success could be forming for this company and it's stock.
With Acetaminophen and other over-the-counter drugs coming under recent heat by the FDA, BioElectronics technology, and therefor their products, could provide a safer and more effective alternative.
BioElectronics has taken a long used medical treatment, electro-magnetic pulse therapy, and miniaturized the entire treatment into a patch that has been demonstrated to reduce pain, swelling and increase the rate of healing. The technology is groundbreaking, in my opinion, and the potential for commercial application is even better.
According to the BioElectronics official website, the company is marketing its products in two product lines, Actipatch and RecoveryRX. The technology has already been approved by the US FDA for some plastic surgery indications and also has approvals in markets around the world for both medical and over-the-counter use.
In the United States, BioElectronics is seeking approval for many other indications, including for both medical and over-the-counter use, and as I said before, with medical narcotics and Acetaminophen coming under fire of late, things could just be heating up for BioElectronics and the Actipatch technology.
I say it often: for the cost of a night out on the town, a small investor has the opportunity to buy a nice chunk of shares of a good risk-reward stock. If it doesn't pay off, you've lost a hangover by skipping the night out. If it does pay off (see: TTNP, CSUH), however, the percentage gains could be huge.
BIEL is trading so low, in my opinion, because of the lack of significant clinical data up until this point. People always get a little bit antsy when something involves electromagnetic pulses is applied to their bodies, but as the safety data has been accumulated and is being put before the FDA for various approvals, the time may be ripe for BioElectronics.
In my opinion, someone is accumulating the stock and keeping the price in a controlled trading range- avoiding any significant spikes or dips in order to keep the stock below the radar.
The volume is growing for the BIEL stock, and the market potential for the product is huge- two things that could equal a lot of dollar signs in the future.
Don't forget to do your own DD, but I like this stock for the risk-reward potential that it holds. To answer the question of the many readers who have asked my opinion both here and on my Seeking Alpha page- VFC says take a chance on this one, nice find.
Disclosure: VFC is long BIEL.
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