Be interesting to see how deep this goes. Did it have anything to do with Amarins 5 year NCE approval ? Note bottom of next to last paragraph,trading in Watson was affected.
Washington D.C., June 15, 2016 — The Securities and Exchange Commission today announced insider trading charges against two hedge fund managers and their source, a former government official accused of deceptively obtaining confidential information from the U.S. Food and Drug Administration (FDA). A third hedge fund manager working at the same investment advisory firm as the alleged insider traders was charged with falsely inflating assets in portfolios he managed.
The SEC alleges that Sanjay Valvani reaped unlawful profits of nearly $32 million for hedge funds investing in health care securities by insider trading on tips he received from Gordon Johnston, who worked at the FDA for a dozen years and remained in close contact with former colleagues while working for a trade association representing generic drug manufacturers and distributors. Johnston concealed his separate role as a hedge fund consultant and obtained confidential information about anticipated FDA approvals for companies to produce enoxaparin, a generic drug that helps prevent the formation of blood clots. Johnston allegedly funneled to Valvani the details of his conversations with FDA personnel, including a close friend he mentored during his time at the agency. Valvani then traded in advance of public announcements concerning FDA approvals for such companies as Momenta Pharmaceuticals, WATSON Pharmaceuticals, and Amphastar Pharmaceuticals.
“We allege that Valvani’s formula for trading success was tapping Johnston to abuse his position of trust as a generic industry representative to the FDA and underhandedly obtain confidential information from his friends and former colleagues at the FDA,” said Andrew J. Ceresney, Director of the SEC’s Division of Enforcement. “Valvani and his hedge funds made millions by trading on nonpublic FDA drug approval information
Absolutely, looking more closely at older trial data should give insight into current trial results. The proof is in the pudding.
AZN, FDA twice, disgruntled investors, and now Watson. Next up FDA yet again, R- it results will expose their faulty science. Putting influence and grudges before science is always a mistake. AJMO.
Little retail shorts are always the last to know. Perhaps you didn' t the email from that shorting house rag you read? Hahaha.
Fishy Fingers predicted a squeeze has begun. To some extent may be true but shorting again at the top is happening. If hedge funds try to get in early to hedge their short positions price should stay close to where it is. We shall see soon enough. So you are right, new interest and buying is the key
" based on such results" kind of says it all. That means seeking label expansion based on the interim results and not that they intend to wait two more years. It is also an insight to me about how anxious they are to get approval and not have to wait two more years. I don't know if there exist any conflict between the two on this point but IMO it certainly seems so. That is why I believe it may have to be settled by litigation. What has Amarin got to lose.....two more years? Angering the FDA... They are already angered. So even if the results are not overwhelming and show significant benefit, if you are Amarin what do have to lose by appealing the Anchor rescindment at that time? Because the FDA is giving Amarin nothing really by setting the goal so high ( overwhelming ) if Amarin can prove that other companies were not held to so high a standard then IMO litigation is justified. Amarin has absolutely nothing to lose.
What you fail to even consider is the fact that if the DMC recommends to stop the trial is enough evidence for label expansion. They certainly are not going to lie about results. Now comes into play Amarins dilemma, should they continue the trial as they stated they would, or should they seek a label expansion for needed additional revenues. They stated in their PR they would try to do both. So, I would assume they are leaving it up to the FDA on how to proceed.
time & reason to dilute shares again and give themselves more free shares and more Total Compensation because, well, they are greedy pigs. L"
I think they are trying not to dilute that is why they want the label expansion. Makes no sense to give themselves shares and at the same time dilute the value when there may exist another option. They may well be greedy pigs and I don't mind at all if they get wealthy as long as they do it via share appreciation. If you really think about it this R-it trial will cost about $100 million Amarin expected that cost but they also expected the Anchor proceeds to help pay for it. I think they are P.Oed about losing those revenues and are telling the FDA since they had an understanding that those revenues would help defray the cost when they agreed to do another expensive ( R-it ) trial that with interim results confirming benefits they want that revenue. We shall see real soon.
You don't have time to play I believe things are moving faster than expected so you better move fast and cover....incoming!!
Amarin's highly refined fish-oil pill is picking up steam
Analysts are also hot on the Irish biopharm Amarin because of a court ruling that allows the company to talk to doctors about the possible benefits of its fish-oil pill, Vascepa, for patients with only moderately high triglyceride levels (as opposed to only severely high levels). In effect, this much larger target market is expected to cause Vascepa's sales to surge over the next 18 months. As a result, the Street thinks that Amarin's stock could appreciate by a whopping 357% by 2017.
Perhaps the real test of this jaw-dropping valuation scenario, though, will be the forthcoming interim data readout for the ongoing REDUCE-IT trial, designed to assess Vascepa's ability to lower the rates of heart attacks and strokes in patients with elevated triglyceride levels. In a nutshell, this interim data readout, which is expected to take place between September and October of this year, could determine the length of Vascepa's commercial runway. After all, there's no real point of prescribing a cholesterol-lowering medicine that doesn't reduce the rates of serious cardiovascular events. On the flip side, if Vascepa does prove to be an important breakthrough in terms of improving long-term cardiovascular outcomes, its sales would almost certainly fall in line with current forecasts. "
Then you would have to assume that the company's intent is to stop the study while blaming the FDA for not allowing it to continue if the FDA did not recognize the fact that a DMC recommendation was enough information for a label expansion. That is the way I interpret what they are saying. I do not know if there exist a written agreement to continue the study, but it seems to me no label expansion with overwhelming efficacy, no continuation of the study.