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.
Don't think it was a 505b2 filing because it would also require a paragraph 4 certification, and ZGNX would have had 45 days to file a lawsuit and that could delay approval for up to 30 months. Therefore I doubt it was a 505b2 filing.
The FDA can do whatever they want. And if Purdue was behind the mis-information PR campaign, the FDA can delay approval and give Zo a 3 year exclusivity. The lesson for Purdue is not to #$%$ off the regulators because they can bite you in the posterior. That PR campaign was arrogant and stupid.
What we're seeing here is an example of the Defense Department, always fighting the last war, and not preparing for the next one. If conventional wisdom is that ZGNX is screwed, good. When has conventional wisdom been correct? People selling ZGNX probably also picked Brazil or Spain to win in their brackets, the conventional wisdom choices. Auf weidersehen.
Good grief Charlie Brown, what a load of misinformation from the pundits and wags of Wall Street, that is reflected in this thread. Let me be clear, the Purdue filing is an NDA, not an ANDA, so there is no paragraph 4 certification and the Orange Book listed patents are not relevant. ZGNX cannot stop the Purdue product and the converse is that Purdue cannot block Zo from the market. They are both sold. Abuse deterrence is pharmacological male bovine excrement to use a Yahoo-acceptable description of the real term. Addiction comes from oral administration and the extended release versions of hydrocodone are less addictive that non-extended release versions. That is pharmacologic fact that the FDA knows and the Wall Street pundits and wags don't. Addicts will want to take immediate release versions of oxycodone orally, abuse deterrent or not. If you need to inject, heroin from the street is better to get an immediate high. The key for addicts is peak plasma concentration, not steady-state of the drug. That is why e-cigarettes provide the same nicotine high as cigarettes but not FDA approved patches or gums. That is why an abuse-deterrent tablet or pill or non-abuse deterrent can go into solution the same and be vaporized in an e-cigarette to get the same high as snorting or injecting and the so-called abuse deterrent properties are irrelevant. The FDA knows this and that is why abuse deterrence is complete male bovine excrement. And why this ignorance from PR misinformation makes ZGNX a screaming buy.
It seems like you need a course in the English language and to note the different meanings of "approval" and "acceptance." The FDA has to decide to accept the NDA in 60 days or not. This has nothing to do with approval or periods of exclusivity under Hatch Waxman. As per usual this stock is clouded by mis-information and obfuscation. And speaking of mis-information, the abuse deterrence is a misnomer because the addictive potential is much higher for the Purdue drugs than Zo. If I needed such a drug (fortunately I don't but I'm getting older), I would take Zo first because the addictive potential of Zo is much lower than Oxycontin or other immediate release drugs (the crush issue is irrelevant to addictive potential) because all I would care about is to not get addicted. This is based on understanding the pharmacokinetics of these drugs. The FDA knows this. Look at nicotine, for example, another highly addictive drug. Smoking cessation devices like the nicotine patches or gums do not work well because they provide a steady state low level of nicotine that doesn't satisfy a smoker's cravings based on smoking, which delivers a high peak in arterial blood straight to the brain within 7 sec of a puff. That is why unregulated e-cigarettes are much better smoking cessation devices for drug delivery of nicotine to step down nicotine. The same happens in opioid addiction. It is peak spikes that cause the addiction. The shorter delivery cycle for oral dosing of an opioid causes higher peaks. It is the height of the peaks that causes the addiction. That's why the addiction problem has been caused by Purdue and others, not Zo. That's why this mis-information campaign is based on ignorance. But the FDA is not ignorant and understands the pharmacokinetics at play here. Abuse deterrence just move the already addicted junkies to buy heroin off the street rather than break into pharmacies. That's like the tail wagging the dog.
That's also why I have boat-loads of patience.