Who gives a flying fig about what bought and paid for media or politicians say. Words are meaningless here. Actions speak far more than words. And the action that speaks the loudest is the filing of an ANDA and subparagraph 4 certification to try to market a generic Zo. Why would a generic invest its time and money in Zo to try to get generic exclusivity if Zo is about to be pulled from the market, as the pundits and wags have alleged? It's more evidence of our corrupt system of the media and politics that are bought and paid-for by money interests (read: Purdue and others). This illustrates why Congress needs to pass strict and severe campaign finance reform because the corrupt crony system we have no only makes the rich richer and the middle class disappear.
This is not material to ZGNX. Despite what the pundits and wags say, any generic can obtain FDA approval after Oct 2016 because that is when the 3 years of Hatch Waxman exclusivity ends. But by filing a lawsuit now (Sept), this means there will be no generic approval until March 2017, at the earliest. That just gave us 5 extra months before a generic can be approved. The incentive for Actavis to fight the lawsuit is it gets 180 day generic exclusivity. By generic exclusivity I mean that can be only two Zo products on the market before the hodes of generics invade the market. And this is not based on the male bovine excrement , so-called abuse deterrent formulation make an appearance.
So while the pundirs and wags will try to spin this negatively, it is actually positive for ZGNX.
Are you referring to the stock promoters who screwed up GALE? That saga showed what a scam seeking alpha is. But what caused the SEC investigation was the former CEO and various Board members to hire the Dream Team to pump up the stock by their social media (such as this message board) and seeking alpha articles and then the insiders sold at the high.
The take-home lesson is that actions speak louder than words, particularly when unknown others are only talking the talk but the insiders are running in the other direction.
Who gives a flying fig about Roth? Or any other numb #$%$ banker for that matter? We're quite capable of evaluating such stock for ourselves, particularly those of us who work in this industry.
This is disturbing that it took this company 8+ years to get an allowance on a barely enforceable method of treatment claim patent. Most pharmas don't bother to partner when the only protection is a method of treatment and not a compound or composition/formulation. According to the press release (it smells of hype to put out a PR on an allowance) the patent term is until 2026. That means the patent application was filed about 8 years ago in 2006. Why has it taken so long to get the patent.?Why has it taken over 8 years to to get to phase 1? Something smells here and this is my biggest losing position (I'm long too many shares).
Idiotic suggestion. SA author is guilty of slander. So what? The article clearly was filled with hedge mud-slinging and no actual facts. Anyone with basic reading comprehension could see that. I took advantage of the article and bought shares. So I should be sued because I purchased shares? And those fools who sold should be entitled to compensation for their own decision? We are not in a nanny state. Take responsibility for your decisions. No one held a gun to your head and told you to sell. If you could not comprehend the article, blame your poor elementary school education.
I did sell in the 12-13 range because I was worried that the stock went up without a catalyst or news. I have since bought back And I'm just some retail s_chmuck who invests for himself. What's the big deal here? The SA article just showed how stupid the short or bear case was. Believe that and I have a bridge to sell you.
These are non-material nuisance suits by the lowest form of legal #$%$. Let the D&O insurance carrier get them dismissed. And you cannot counter-sue under Noerr Pennington. No one with any industry knowledge cares about them.
Seriously? Lack of knowledge? It doesn't matter how much money is in the bank. When there is no more revenue, whatever's in the bank runs out fast. BK will be chapter 7 liquidation (not 11 restructuring) and the common shareholders take last. You can believe all the male bovine excrement put out in press releases but the FDA shuts you down and imposes jail time if it's directives are violated. Forrest Gump was right, stupid is as stupid does.
Muddy Waters is run by a lawyer who knows to put out actual evidence, not innuendo and mudslinging that was done to CXDC. Then the Pavlovian response by the class action shareholder plaintiff's bar is in response to the share price drop but they didn't do an investigation. Most companies have D&O insurance to cover this form of nuisance. The legal fees will be low because there is a high pleading standard and there's no evidence to support the pleading standard. As for the former SEC lawyer hype, how do you know he/she wasn't fired from the SEC for incompetence and instead of following the well-trodden path to major NY law firms (like Shearman) where he couldn't get a job, had to open up his own ambulance-chasing shop?
These suits will be dismissed pronto. There's no evidence. It's all male bovine excrement bluster. By the way it's spelled Shearman. I've worked with them on some deals.
This looks like some puppet master is trying to scare the excrement out of naïve investors. The lawsuits will be immediately dismissed. There's no evidence. They are based on the seeking alpha article which was rank speculation and innuendo, no actual facts or admissible evidence. The innuendo was refuted by the company. The next quarterly earnings are coming up soon. If there has been financial monkey business it will have to come out in the next earnings report. But these numb #$%$ ambulance-chasing excrement lawyers are urinating into the wind and are going nowhere as they have no facts, no evidence and also have the burden of proof with an extremely high pleading standard. In other words, all bark and no bite. It's a buy.
This is not how shareholder lawsuits proceed. This will be immediately dismissed for failure to show scienter. The lawsuit will have to name the Board members. The Board members will have D&O insurance. The D&O carrier will manage the defense and pay for it. Yes reform is needed but it can be accomplished by having a loser pays system for only shareholder lawsuits.
One cannot counter-claim for filing a lawsuit under Norr-Pennington. Until Congress passes a law (don't hold your breath here) creating a system of loser pays the other side's attorney fees, these low life trolls file lawsuits just because a stock price dropped, though at no fault of the company. The trolls then try to extort some settlement out of the D&O insurance carrier as a nuisance. DON'T FEED THE TROLLS!
I don't think Purdue filed a 505b2 NDA. The reason is that such an NDA also requires filing a subparagraph iv certification for the Orange Book patents of Zo. Zog would have had 45 days after service to file a patent infringement lawsuit, which can lead to a 30 month delay of the FDA approving Purdue's product. If such a certification was filed, the lawsuit would also have been filed because we are beyond 45 days. Yet I cannot find any evidence of such a lawsuit. That's why I don't think it was a 505b2 filing.
An extension of what? Where's the precedent or statute to grant patent term extension due to corrupt politicians paid off by lobbyists?
As I've continually been posting, the correct legal action for Zog to take is false advertising against Purdue for funding the lobbying activity that created the corrupt politician response. And the recent Supreme Court precedent shows that Zog has standing for such a lawsuit and the damages are increasing. The only relevant question is when will the false advertising lawsuit be filed. Then watch Purdue keep it's fat yap shut and run for the hills.
Another idiotic post. "In talks with the Supreme Court?" Read the Constitution first. The Supremes are the highest level appeals court.
"If the Purdue version is approved they [Zog] are screwed." Really now? How so? An inferior (from a safety and efficacy standpoint) product is on the market. How is Zog screwed from that? Abuse deterrence does not confer any exclusivity rights on Purdue. Those rights are based on use of data. And Zo is 12 hour sustained release and Purdue is a dodgy (in terms of poor pharmacokinetics) 24 hour release that is much more difficult to achieve. One is not equivalent to the other. Just like Zog cannot block Purdue, Purdue, after it receives approval, cannot block Zog.
The level of mis-information here is astounding and rivals the nonsense being spouted by the corrupt and paid-off politicians.
You're all missing the point of Hatch Waxman exclusivity. It is access to the data that Zog used to gain FDA approval for Zo. It is relevant if Purdue uses these data to gain approval for its product. But from what I'm reading, Purdue re-ran all of the clinical trials themselves de novo and did not rely on the Zo data. By running all of the trials de novo, Purdue can defeat exclusivity. Moreover, Zo is a 12 hour sustained release formulation. Purdue is 24 hour sustained release. Those are not the same.
As a pharmacologist, I would worry about the pharmacokinetics of a 24 hour pill or tablet, especially with all of the so-called abuse-deterrent stuff. But don't get me started on the stupidity of abuse deterrence as being relevant. Addiction is a function of the spike in plasma drug levels of an addictive drug. Sustained release avoids the spike. Truly dangerous drugs (from an addiction standpoint) are Oxycontin and immediate release formulations, based on oral administration.
It's always dangerous when we have fake lawyers posting on stock boards. This post is ignorant because it shows one looking only on the internet with no or zero underlying knowledge of what he or she is looking at. It utterly confuses different legal concepts. Yes, there are Orange Book patents. So what? A patent is a preclusive right. There is also 3 years of Hatch Waxman exclusivity from the date of FDA approval.
BUT both of those exclusionary rights are not relevant to Purdue. So long as Purdue conducts its own safety and efficacy trials and files a regular 505b NDA (not a 505b2 or an ANDA), the two forms of exclusion for Zo are not relevant. Is there patent infringement?
It also means approval of the Purdue product will not impact Zo or take it off the market. Let the competition begin where the whole abuse deterrent nonsense is all male bovine excrement and completely irrelevant, except to corrupt politicians.