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Jefferies Group, Inc. Message Board

bryanemail65 10 posts  |  Last Activity: Jul 31, 2014 8:52 PM Member since: Oct 13, 2010
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  • Reply to

    Oregon LNG / 52-week low

    by mastermind_not Jul 31, 2014 1:57 PM
    bryanemail65 bryanemail65 Jul 31, 2014 8:52 PM Flag

    Regulatory approval at the federal level was expected. So too is FERC approval.

    The big regulatory obstacle for Oregon LNG to overcome is state and local approvals.

    A lot of local opposition remains, hence the lack of upward movement in the share price of LUK.

    LCCE is the big asset that the market seems to be neglecting. It is already fully approved and under construction and it will add significant incremental earnings/ cash flow to the bottom line in a few years.

    Enjoying the pps decline while waiting for the cattle herd to expand and LCCE production to commence. Oregon LNG would be a massive bonus should it end up obtaining all regulatory requirements at both state and federal level.

  • Reply to

    Orange Book 3yr exclusivity

    by bluehawaii00 Jul 9, 2014 12:00 PM
    bryanemail65 bryanemail65 Jul 9, 2014 7:20 PM Flag

    " Maybe the FDA for the first time in history reneges on their exclusivity deal, but I don't think it will work out that way."

    Sounds like you are the one "hedging their responses" now.

    This is your last response because you are not interested in debating this? You sure seemed really interested in debating this all afternoon, Up until the point I post the 10k excerpt for you in black and white.

    Instead of saying "you know" how about you post some material to buttress your claims. Seriously, I am here to better understand all the variables. Not simply to pick a fight. Perhaps you are right. At one point (after the initial purdue news and concurrent 30% decline on massive volume) I too thought ZGNX would be able to seek refuge under hatch waxman. But market participants much larger than I have spoken by selling their shares. I believe I was wrong and the 10K basically says I was wrong.

    Why hasn't your hero roger Hawley filed legal documents for infringement on ZGNX hatch waxman exclusivity? Maybe they are waiting on alkermes, but both alk and zgnx knew this day was coming for months. One would think they would have taken swift decisive action. Unless waiting up until the 44th day affords additional time to keep purdue approval from happening in the unlikely event of a 30 month stay of approval. But why allow such uncertainty to exist in the marketplace?

    C'mon man. Let's keep going. This might just be the most substantive threads on the ZGNX message board. I mean, we are actually discussing source documents!

  • Reply to

    A message for all zo longs.......

    by jaft1234 Jul 9, 2014 5:32 PM
    bryanemail65 bryanemail65 Jul 9, 2014 6:23 PM Flag

    - Zogenix was granted 3-year new product exclusivity by the FDA upon approval of Zohydro ER. If after reviewing Purdue's NDA they decide that they should approve it, the 3-year exclusivity could still protect Zohydro ER and delay the approval of Purdue's product until the exclusivity period expires. It is difficult to predict the likelihood of this occurring, but it is possible.

    - if the Purdue product is approved and on the market in October 2014, Zohydro ER will most likely still be available, it will just have a new competitor.

    Notice the word "could"...3 year exclusivity COULD still protect....difficult to predict....but it is POSSIBLE
    Not WILL protect....and not DEFINITELY.

    And they even go on to entertain the scenario of purdue's pill being on the market in 2014.


  • Reply to

    Orange Book 3yr exclusivity

    by bluehawaii00 Jul 9, 2014 12:00 PM
    bryanemail65 bryanemail65 Jul 9, 2014 6:06 PM Flag

    Yahoo won't let me post the entire paragraph, so we will not be able to play the reading game. Instead here are the relevant sentences.

    U.S. Patent Nos. 6,902,742 and 6,228,398 relating to Zohydro ER covers a modified release composition containing hydrocodone and are expected to expire in November 2019

    Additionally, since these eleven patents are the only patents currently listed in the FDA Orange Book for Sumavel DosePro, or the two patents listed for Zohydro ER, their expiration will mean that we lose certain advantages that come with Orange Book listing of patents. The expiration of these patents could also have a similar material adverse effect on our business, results of operations, financial condition and prospects.

    The patent rights that we have in-licensed covering Zohydro ER are limited to a modified release composition containing hydrocodone. As a result, our market opportunity for this product may be limited by the lack of patent protection for the active ingredient itself and other formulations of hydrocodone.

    The active ingredient in Zohydro ER is hydrocodone. Patent protection is not available for the hydrocodone molecule itself in the United States. As a result, competitors who obtain the requisite regulatory approval can offer products with the same active ingredient as Zohydro ER so long as the competitors do not infringe any patents that we have in-licensed....

    Are you able to read this?

  • Reply to

    Orange Book 3yr exclusivity

    by bluehawaii00 Jul 9, 2014 12:00 PM
    bryanemail65 bryanemail65 Jul 9, 2014 5:07 PM Flag

    Ugh, you really are dense. That's all you have to say? Call roger Hawley? Funny thing is, I did try to contact ir 3 times yesterday but it goes straight to voicemail. What a joke. And roger Hawley is the same imbecile that chose to get into this game and go it alone without the protection and cover of an established partner. It's tantamount to a 18 year old punk kid trying to move into Compton on his own and attempting to carve out his own block to sell heroin. Zgnx is getting smacked around by the established players of the government sanctioned corporate drug dealing arena. Roger Hawley is a joke.

    And please do tell me just how involved are you in "this orange book patent?" If you care to elaborate it would likely help me "realize."

    Since you haven't taken the time to read or respond to the excerpt I posted from the 10K, I am posting another excerpt which unambiguously refute your expert claims. You will find it below. Let's see if you can pick out the relevant sentences.

  • Reply to

    Orange Book 3yr exclusivity

    by bluehawaii00 Jul 9, 2014 12:00 PM
    bryanemail65 bryanemail65 Jul 9, 2014 3:07 PM Flag

    Clearly you are unable to read or simply choose not to read.

    Do yourself a favor and open up the 10K and skip to the section "risks related to intellectual property"

    READ the entire section.

    I'm not suggesting that ZGNX will not challenge purdue's NDA (although alkermes ultimately has the first right to do so,) but any litigation will not hold up Purdue's NDA approval for 30 months. Unless of course purdue's technology does in fact infringe on ALKERMES owned intellectual property, which I believe is unlikely.

    Here is one small section from "risks related to intellectual property." Let's see if you can pick out the relevant sentence. That is, if you are in fact able to read.

    The filing of a patent infringement lawsuit within 45 days of the receipt of notice of a Paragraph IV patent certification automatically prevents the FDA from approving the NDA or ANDA until the earlier of the expiration of a 30-month period, the expiration of the patents, the entry of a settlement order stating that the patents are invalid or not infringed, a decision in the infringement case that is favorable to the NDA or ANDA applicant, or such shorter or longer period as the court may order. If a patent infringement lawsuit is not initiated within the required 45-day period, the third-party’s NDA or ANDA will not be subject to the 30-month stay.

  • Reply to

    Orange Book 3yr exclusivity

    by bluehawaii00 Jul 9, 2014 12:00 PM
    bryanemail65 bryanemail65 Jul 9, 2014 2:16 PM Flag

    Does anybody here even read SEC filings? It seems Jim Chanos is correct, it is amazing how many people do not read source documents.

    The ZGNX 10K clearly states that their patent protection only applies to the delivery mechanism used in
    Zohydro. It is not possible to patent hydrocodone.

    Remember the big sell off when purdue first announced it's intentions to file an NDA? If hatch waxman was going to afford ZGNX any cover the price would not have plummeted 25-30% on massive volume.

    It is the delivery mechanism that has patent exclusivity. Purdue likely has a different delivery method for their version. Just as there are multiple abuse deterrent formulations, there are more than one delivery methods.

    Doesn't mean ZGNX is dead, they just have a big uphill battle ahead of them. Script numbers are nowhere close to break even. Need to see marked improvement in these numbers for ZGNX to rise.

  • bryanemail65 by bryanemail65 Jun 27, 2014 7:10 PM Flag

    Cnbc real time app showing Zgnx at 2.10 after hours on 1.8 million shares traded.

    Roughly 4%

  • Reply to

    Oregon LNG

    by x1kyle26 Jun 19, 2014 3:50 PM
    bryanemail65 bryanemail65 Jun 24, 2014 2:26 PM Flag

    Oregon LNG is allegedly next in line for FERC review / approval.

    Perhaps a short term catalyst to LUK price, however, Oregon LNG still faces a lot of local opposition and must overcome further regulatory hurdles.

    That said, Lake Charles Clean Engergy is already approved and under construction. LCCE will add significant incremental earnings to LUK's bottom line.

    I am not entirely sure when LCCE begins operations, but I believe it is 2015 or 2016.

  • Reply to

    The Kiss of Death

    by bryanemail65 Apr 10, 2014 7:38 PM
    bryanemail65 bryanemail65 Jun 24, 2014 2:01 PM Flag

    Its been 19 days since Burwell was confirmed as HHS Secretary. I would expect a statement one way or another regarding Zohdyro within 41 days, otherwise ZGNX is likely in the clear regarding this risk.

    Here is the video of Chuck Schumer discussing Zohydro at Burwell's confirmation hearing.

    W . W . W c-span DOT org/video/?319354-1/hhs-secretary-confirmation-hearing

    Links don't seem to work in Yahoo so just google :

    "sylvia burwell confirmation hearing schumer"

    It is the c-span video at top of page

    Relevant section begins at the 2:03 mark and ends at 2:05.

    I like that Burwell used the "science based decisions" language, however she did indicate that she would want to look into the approval process if confirmed.

    I did not like Schumers statement at the end, "I know who you are and I think you will get involved."

    Very confident language and "I know who you are" could be read as a veiled threat. (Schumer could have dirt on Burwell.)

    You can also find video of Manchin going goo goo ga ga about burwell at the hearing introduction if you are so inclined.

    Just trying to consider all the variables and risk factors....

    Let the overweight longs hate messaging begin

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