Our apologies to you drrc and to Yahoo MB followers. Your interpretation as to the intent of our post in reference to "lost time" is correct. We thought that the NCE counter starts on the determination date rather than the approval date of Vascepa. Again, we apologize and we will continue to improve the quality of our DD not only on AMRN, but with other investments as well.
As we await the NCE ruling for AMRN, we have come to conclude that the GIA decision was a brilliant strategy. Certainly many skeptics are all pointing to a supposedly dismal scripts and that a partnership with a BP would have help increase those numbers. It is something that we can all ponder, but not worry about. First, GIA is not easy, considering the many hurdles that needed to be surmounted (staffing, doctor networks, training, etc.) Secondly, we have to worry about the financial aspect and what this means to the company. These are legitimate questions.
On the other hand, we can also see that there is progress being made. The sNDA for Anchor was already in the hands of the FDA. Also, the company have been increasing their patent portfolio, including pending patent application in Europe. These are catalysts, which are currently ignored by skeptics.
Our view is that the company's GIA decision was timely in the absence of an NCE ruling. It actually benefited the company, allowing them to gauge the market, which could help in its valuation. We also thought that further NCE delay will benefit prospective BP buyers in the sense that time that is normally lost during the introductory phase of new drugs will no longer count against a 3 or 5 year NCE ruling.
Given these reasons, we will welcome any further delay on NCE ruling.
Yesterday was a very good day for longs. A really good day to laugh as bashers were all over the MB planting all kinds of fear to anybody that would listen to their argument. Accordingly, AMRN is going down to $1.50, running out of cash or going bankrupt. It's all laughable argument, but bashers won the day yesterday. Today was going to be another down day, instead some shorts started to cover. It is going to be the same tomorrow as nervousness starts to creep-in, specifically that AMRN management decided to stay quiet.
For sure, AMRN management is trying to change strategy. Early on, management were so vocal about selling the company right after the FDA approval of Vascepa. However, they are now working on being decisive but cautious. Bashers pointed out many times over that AMRN is not going to make it due to lack of partnership or an imminent buyout. This is a very shallow analysis. AMRN's management indicated before that partnership can be messy and problematic (perhaps, not in the best interest of the company). Though they insinuated that it will be an option for the Anchor if a buyout will not happen before then.
So, if AMRN management is quiet, it's because they are working aggressively with BP.
The downward pressure on AMRN's pps that was building for the past few weeks was realized this morning when the stock capitulated to a new 52 week low of $6.80. The stock is now in oversold territory and some short positions should start to cover soon.
We believed that the weak pps trend during the past few months is a bottoming process and the accelerated downward pps move this morning was perhaps an indication that the stock is approaching its bottom. Should expect to see some positive stock movement this afternoon with short position inspired rally.
Thanks for your nice choice of words. It's a good start for a good and intelligent argument, which leads us to your point in regards to Vascepa's chances..."the decupling of the potential treatment universe." It is a very positive thought, considering the myriads of positive opinions written about the drug, which could easily multiply your investment tenfold (thus, decupling), given its wider application with Anchor.
However, as investors, we do not want to rely so much on the "potential" of any given stocks. We would rather value the stock based on measurable data sets.
The almost daily decline in AMRN's share value this month could trigger BP interest to go directly to share holders to present their buy out offer. It is a big opportunity for them at this point as AMRN's market value is now $1.19 billion. Forget about the future possibilities as many bulls are contending. We have been a bull too and have been projecting a buy out at $25-28 range depending on several factors such as NCE and sales projection.
However, the erosion of AMRN's share price during the last six months made us rethink our position. Although we are cautiously optimistic that AMRN will be able to rebound on a favorable NCE decision, we believe that it will take more than a positive NCE outcome to move the PPS over $10.
At this juncture, BP can probably offer $2-2.5 billion and shareholders will be happy with it.
We now believed that AMRN did not entertain partnership to market Vascepa not because interest was lacking, but mainly to avoid complications with ongoing negotiations. Our analysis points to three possible scenarios:
1. AMRN received multiple BO offers, but are well below their asking price.
2. Management believed that partnering with any of the BP suitors would limit their options (Management already indicated that this is the least of their options, but would consider it as the market for Vascepa gets bigger).
3. GIA is a tactical decision. This could provide an indicator as to market appetite for Vascepa, which would help value the company in the absence of an NCE. Perhaps, BP suitors are also weighing on the sales outcome in order to validate their offer.
We also think that the importance of the NCE is diminishing as a result of the extended delays and the growing patent portfolio that should protect Vascepa until 2030.
It's a great start to have Vascepa covered by United Healthcare, the largest health insurance provider in the nation. This will become effective February 15, 2013 (Sorry, tried posting the URL several times, but unsuccessful). Please search in Google: Vascepa + United Healthcare.
A while back, a used car in LA went on sale for $30,000.00. It was a 2004 Lamborghini, and a lot of people thought it was a bargain for this price. By the way it was advertised as V10 Gallardo model.
The person who bought it did not really paid attention to the details, specifically its history and the reason for the low price. Most importantly, the person relied on the seller's pitch and did not really paid attention to the "disclaimer." It turned out, it was a converted Mitsubishi sports car.
What does the story have to do with Vascepa? Well, some people on this board insinuated that non-FDA approved TG medicines (if it works at all) can be had at GNC stores for less and should work the same as Vascepa. Like the Lamborghini story, the converted Mitsubishi had the look of a V10 Lamborghini Gallardo, but couldn't top its performance.
Which is the reason non-FDA approved drugs carry the disclaimer: Not Approved by the FDA, to warn people about the possibility of buying something that is akin to the Lamborghini story.
Sentiment: Strong Buy
I concur with your observation. It appears that AMRN is really trying to sell itself, but NCE status appears to be weighing a lot in the negotiation process. Also, AMRN indicated that the company would like to get an NCE, but would prefer a denial to another delay.
So, AMRN got another NCE decision delay today. This is the frustrating part because this could go on indefinitely. I wonder if there is something that can be done such as a "mandamus" in order to compel the FDA to issue a ruling. I believed that this judicial procedure can be effective if enough petitioners are to petition the FDA for a ruling. Once refused, same petitioners can seek a relief from the court who could then issue a "writ of mandamus" to the FDA.
Just a thought.
Let me expound. I must admit that making decisions are not always easy. At the same time, decisions are important in all aspects of life, because it allows all of us to do the "things" that we have to do.
In this case, FDA decision (5 years or 3 years NCE) would have given Amarin certain direction as to its bargaining power in order to find the right value mix for its shareholders. The FDA indecision is really holding up progress for Amarin, so that it can only pursue very limited options, which is the reason that a "No decision of a 5 year NCE" would have been preferable.
My point is that if the FDA is going to make a decision for No 5 years NCE, then articulate the decision. It shouldn't take this long to decide if Amarin's Vascepa deserve a 5 year exclusivity based on FDA parameters. This is not something that the agency has to test in its lab in order to make a determination.
So, why is it taking this long to make a determination? For sure, we have to question their competence. Are they competent? Should the agency adopt a deadline policy when making a determination?
First, competence is a very subjective matter, but I am beginning to think that this is becoming a threat to companies that are reliant from the agency for their survival. Second, I think that the agency should adopt a deadline policy. This would minimize foot dragging and would provide assurance to companies it serves that there is going to be a resolution on or before a certain date.
This hesitancy by the FDA to act on Vascepa is not acceptable at this stage. FDA tactic of foot-dragging on the issue of NCE status for Vascepa is unfair and incomprehensible. It is unacceptable for a government organization to continue on such a foot-dragging measure to punish a company for whatever reasons. There must be a mechanism for this type of organizational behavior to stop such as putting a time limit of 60 days or so. If no action after that date--should be construed as approved. What a waste of public resources to continue funding an organization that is incapable of making a decision.
I am puzzled that some bio-companies who claim to have Rx products that are better than others are not seeking peer-reviewed publications for product validation. This was the case with an article from SA about Omthera's claim that its TG product (not yet FDA approved) is better than Amarin's FDA approved Vascepa.
If Omthera really believed that its TG product is superior than either Lovaza or Vascepa, then get it peer reviewed, rather that touting it to Joe the plumber who clearly don't have any idea about what was being discussed.
My guess is that Omthera and its surrogates are not really interested in the science, but in its pps in order to dump it for a quick buck.
The SA Omthera article is really fishy...
Inferior products, services, analysts and anything less desirable will always be in the limelight regardless of how poor their performance are. One reason for this is because they are very good in accentuating whatever little positive qualities they have. It is an old practice that will never change. Be vigilant, understand what is going on and ignore all the bells and whistle that others are using to keep you off track and you will be fine.
By the way, based on all available information, AMRN is still the best in class. Cheers.
Some so called financial news outlets, specifically those that specialized in biotechnology are driven not by the desire to educate their readers about the merits of promising drug products, but to take advantage of the uninitiated in behalf of someone or some company for a quick profit.
These individuals use their position of authority to influence the market, even using the "Safe Harbor
Statement" as an evidence that a company or companies are somehow hiding something or on the verge of collapse due to such statement. I won't doubt for a moment that the same individuals are in cahoots with others in the name of greed.
So, watch out for those writers (not market analyst) who use FUD for their own selfish gains. Watch when they use general terms to support their position or other unrelated information.
Be wary of who the source is--keeping in mind that trust should never be compromised. Check too for the integrity of the source. I have been burned too many times for not paying attention to my sources.
Enough with the FUD. Time to actually look back to Dr. Goldenberg's article about Vascepa having a distinct chemical entity as compared to Lovaza. Many have suggested that Vascepa's chemical make up is not new since it resembled that of Lovaza. But based on old transcripts, Lovaza's chemical make up was not clearly understood when it first went through the FDA scrutiny. This would make it very susceptible to legal, as well as medical challenge--which is the point of Dr. Goldenberg. I would say that NCE is 80 percent based on old Lovaza transcripts. Also, the issuance of patents for 889 and 153 makes it more convincing.
Sentiment: Strong Buy
Here is the analysis:
Based on our prediction, using our own probability analysis, there is only 20% chance that AMRN is going to launch Vascepa on its own and 60% chance that its going to partner with a big pharma, while a buyout is about 80%.
First, launching a drug on your own is a nightmare. It requires hundreds of people who need to be educated about the drug. Logistics too is going to be a concern, as well as back office support. Big pharma understand this situation, which is one of the reason that AMRN has very limited options when talking about selling out despite having a drug that is considered to be superior to Lovaza.
Second, partnering with a big pharma will also be problematic in terms of AMRN's long term view. Remember that AMRN is good at R & D, but not necessarily in running a business where revenue becomes important. This means that AMRN is not really enthusiastic about this option. In fact, AMRN indicated that this is not something that they would prefer. Consider, yes! but not a desirable option.
Third, the company stated many times that they are looking for a buyer. One reason that we have not seen or heard an announcement offer should not be a cause for panic, but an acknowledgement of how good management is in handling news flow. This is very frustrating to all of us, but it is a necessary procedure in situations such as AMRN's.
Ultimately, we expect a buy out with several contingencies, reflecting several scenarios such as 3 year NCE, 5 year NCE and patent protection.
I believed that AMRN and AZN already concluded their negotiations with the following result:
*AMRN will be bought for $23 with 3 years exclusivity and $28 with 5 years exclusivity.
The announcement will be made immediately after FDA NCE determination in November. GLTA