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Ton of Insider Buying going on. If you look up Insider buying, all you will see is BUYS, no SELLS.
Looks like a BEAR raid to me! Sell your shares cheap, so the Tutes can make money on them./sarc
Removed my post earlier. I expect Zgnx to take off very soon, Fri. or Mon.
I posted this 2 days ago, because I was concerned about the same thing. Until i read:
The Prescription Drug User Fee Act (PDUFA) date for completion of the review by the FDA is March 1, 2013. If approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA) Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products. Zogenix has included in the NDA a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is consistent with current FDA and industry-wide guidelines for extended-release opioid products. The REMS is intended to control inappropriate prescribing, misuse and abuse of extended-release opioids while maintaining patient access to essential pain medications.
More
Source: press release, 11/08/12. http://ir.zogenix.com/phoenix.zhtml?c=220862&p=RssLanding&cat=news&id=17...
"consistent with current FDA and industry-wide guidelines for extended-release opioid products." This is the answer I've been looking for.
Inept gov't servers, file won't load. Can you post anything about what it says?
Was there earlier today. No recent updates. Guess I'll wait til morning to find out. GLTA
Duh getting tired, forgot to post!
http://www.fda.gov/AdvisoryCommittees/WhatsNew/default.htm
Found another FDA link. Hopefully better than the last. It appears to be "Recently Updated Advisory Committee Materials"
Found this FDA link. I'm hoping it will let me know something after 12, but i doubt it. I'm pessimistic when it comes to the gov't.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm327624.htm
Thanx JJ, you never know with VRNG. Everything seems to have implications, with this stock. Glad to have you find out, TY.
Fidelity reads the same. $3.37
Thanx just posted it on vringfreeforum. Hopefully someone can access it and let us know what it's about.
Doc 810 with 5 attachments is my concern. What are the attachments?
For some relly good discussions on settlement/buyout, appeal and daily price movements talks for VRNG. The vring freeforum.net seemed to answer most questions the best. Give it a read, just read about it yesterday. It answered all of my questions.
AdCom notes will be released on Wed morning, 2 days ahead of the panel
Agreed it is BS. Looks like some, not all, of the MM's got on board this morning. Or their pockets weren't full enough and they're still looking for more sellers.
Still trying to buy another 1k shares today myself. I missed the boat in selling my FF shares. Thought I had GTC order in, but it was a Day order instead. Price went back down after I discovered my mistake. ZGNX price back down, below $2.50 also, hopefully won't miss another boat.
The 1st 1/2 hour over 850K volume. Pretty good, hope it continues up.
"Maybe they can find another 300k shares tomorrow morning, but there can't be many out there to short - the number being grabbed by institutions has to slow or stop any being availsble in retail hands."
They magically create as many naked shorts as can be sold. The SEC is nothing that they can't handle. Money corrupts all of us. Particulary gov't employees, who would rather sit around watching PORN than doing their job.
Tamper resistance and FDA approval. I found more information concerning exactly this. ZGNX should not have any problems coming from the FDA because of this;
The Prescription Drug User Fee Act (PDUFA) date for completion of the review by the FDA is March 1, 2013. If approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA) Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products. Zogenix has included in the NDA a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is consistent with current FDA and industry-wide guidelines for extended-release opioid products. The REMS is intended to control inappropriate prescribing, misuse and abuse of extended-release opioids while maintaining patient access to essential pain medications.
More
Source: press release, 11/08/12. http://ir.zogenix.com/phoenix.zhtml?c=220862&p=RssLanding&cat=news&id=17...
"consistent with current FDA and industry-wide guidelines for extended-release opioid products." This is the answer I've been looking for.
Hope to add some more myself tommorow.
Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that the U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) will review the Company's New Drug Application (NDA) for Zohydroâ„¢ ER (hydrocodone bitartrate extended-release capsules) on December 7, 2012. Zohydro ER is Zogenix's lead investigational product candidate for the management of moderate-to-severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Details of the meeting agenda will be available in the Federal Register.
Fed. Reg., is the official journal of the federal government of the United States that contains most routine publications and public notices of government agencies. It is a daily (except holidays) publication.
Maybe sooner than Monday, hopefully?
From the Motley Fool "4 Stories to Watch This Week in the Health-Care Sector"
As we close in on the end of the year, news stories in the health-care sector tend to get a bit scarcer. However, this week we still have four worthwhile events to keep our attention.
First up, in the biotech sector, we have an FDA panel meeting scheduled on Friday for Zogenix (Nasdaq: ZGNX ) and its around-the-clock, oral, pain-management drug, Zohydro ER, which uses hydrocodone without acetaminophen (a common drug that can cause liver toxicity if used excessively). In August, Zogenix reported positive phase 3 results demonstrating that the drug met its two primary endpoints: the proportion of patients with a minimum of 30% improvement in pain tolerability and satisfaction with the medication. My guess is that with few safety concerns and having been well tolerated in trials, there probably won't be too much in the way of negative news during the panel review.
Big MM's have been buying this, and other bio-techs all day. Dropping pps, yet very high positive money flow. Same thing is happenning to YMI, ARNA, and others. That's what wall street big money does to us little guys.
Thanx, I couldn't find it. Good that we will know before EOD Fri. But today there is a lot of heavy buying (accumalation), all while the decreasing stock price, in this and other bio-tech stocks. Great buying opportunity, I need to sell some other stocks to take advantage of it. Waiting for FF to hit $11.72. Made $1300 with divy on 11/29, paydate 12/17
Manipulation on ZGNX means pps will rise after MM's fill their pockets with cheap shares! Also money flow continues to rise.
Big Boy accumalation today! Stock Money Flow on Barron's show 1.35 A ratio above one suggests greater buying pressure, below one suggests greater selling
What time on Friday will the ADCOM Panel Meeting be?
Heavy volume today, over 400K already. Price will go up again soon!
It should, but all of the manipulation by MM's it probably won't. Not until all the tutes have bought enough chap shares from weak hands, will this stock rise to where it should be, $5-$6 a share
Just bought into it last week. 2500 sh. for $2.58 waiting for the run-up. Watching out for any negatives before adcom Dec. 7. Also own ARNA, YMI, HEB, SVNT and CEMI. ARNA and VRNG are very heavily manipulated and needed to diversify into other growth stocks. I see a lot of potential in ZGNX and SVNT recently.
Thanx for the clarification. I was reading 2 different IHUB boards and YMB as well. I will try to keep them separate, while watching the Pats/Fins game. Go Fins, beat Belichick and company
Looking at VRNG last post, not ZGNX. What 400K sale are you referencing. I looked on the Nasdaq and saw only Insider Buys. no sales, for ZGNX.
What I don't know about Alexander Berger's "indirect sale" of 4,000 shares is if it was an options trade or some of the 1,830,688 shares that he owns. It doesn't make much difference. He owns a substantial sum and if he wanted could have sold a lot more. Maybe bought the wife a Xmas present, who knows? To much is unknown! In the larger scheme of things it doesn't appear to matter.
Still too many unknowns. I am waiting for more info. Don't think it changes much.
?????????? Who knows, higher probably, but no one, except for hedgefund managers and MM's can be certain of it.
I beg to differ. Although ZGNX is a good BioPharma play. The biggest would be ARNA. Which I also own and hope to reap rewards on this month also. After DEA designation and EU approval.
Thank You for responding money2013, but that does not answer my question. But, I did see an answer to it on the YMB, by cruelsister. He has done good DD and seems aware of both the good and the bad(not much bad btw). His answer to alexander was;
"Alexander- there never was any doubt after the results of the trial were released that Zohydro is both safe and efficacious. From the medical standpoint overwhelming approval is assured.
The only thing that is unknown is if they will make an issue about the lack of tamper resistance. Although as we all know the FDA isn't bound to whatever comes out of the meeting investor sentiment will certainly be affected. Zogenix has many things going for it, but I'm sure there are many out there like myself who are up well over 50% on this stock and are loath to lose those profits. If there were options on the stock we could protect with Puts, but since there are not..."
I will hold my position and wait for Dec.7
I am long on ZGNX and would like to know something. I've read on YMB about Tamper resistant for opioids being available, as the biggest deterrent to approval. Is this true, is my question. I am long, and I want to know about all of the risks involved.
Bashers are all over YMB today. All of them in panic mode.