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.
From a purely technical analysis viewpoint, we are at the bottom now in the upper 7's. But there is also market risk that may bring it down even lower. I'm getting an itchy finger but worried about catching a falling knife.
I'm also looking to get back in but am looking for a bottom. Bought in the upper 4's, sold in the 12's and now looking to buy back. I'm not usually this lucky. More often my timing is terrible.
No it doesn't mean insiders KNOW something. That would be insider trading. It means that insiders feel but do not know that the price of the stock SHOULD eventually go higher. Remember the insiders also have the short swing rule which means any insider who bought cannot sell any shares (regardless when those shares were acquired) within 6 months from the last purchase date. While insider buys are generally good things, one must adjust their timeline into 6+ months for the good things to materialize.
You're referencing the PCT application. The press release contained a US patent application serial number. Based on what you've written, CTIX should just now be setting up to enter foreign national phase applications because we're about to hit the 30 month date from priority. That would mean they are just now filing the US national application, based on the PCT. But the application number in the press release is not a number that would just have been assigned (the press release had a 13 series number, but current applications have a 14 series number). Again, something is screwy in the press release. It does not compute. As you can tell, I work with patents for a living so this is why I caught what appears to be an error in the press release.
Today's press release was a grab bag of not-really-material stuff. The sum of the trivial does not equal a material new event. Let's look at the patent application paragraph. The press release provided the serial number (13/730,247) of this alleged patent application that allegedly received a Notice of Allowance. I wanted to see the history of this patent application and what are the claims that were allegedly allowed.
I looked it up on the public PAIR system at the Patent Office web site because that patent application should be available for public inspection (or else why would the serial number be listed in the press release). But the PAIR site indicated that this was not a valid serial number. Huh? That usually means the serial number is incorrect or that the patent application was not published (and therefore not available for public inspection, or the patent application was abandoned before it was published). Something's wrong because that serial number (and serial numbers are assigned sequentially based upon filing date) should have already been published and the file history available to the public. I don't know what is the problem here but this is alarming. I'm thinking of selling my long position because this looks like poor quality management operating this circus.
I'm also in ARDM (soon without the D) but not POZN. But with ARDM I'm concerned about the changing CF market segment in view of the phase 3 data coming up very soon from VRTX. I don't like ENCT, even before the drop, because I didn't see folate receptor targeting as effective in light of the hordes of ADC's being developed, but that is my scientific bias. I'll research POZN.
I'm in the typical cohort of AB stocks, TTPH, CEMP, CTIX. I was in Trius and then bought DRTX and the others when Trius got bought out (announcement, not closing). Any others out there I should look at? I'm also in some stocks that have a larger clinical development portfolio (BLRX and EVT.de), but try to stay away from those clinical development companies that focus on oncology indications (clinical trial outcomes are too unpredictable). And I'm long ZGNX because the media smear campaign was replete with false information.