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enigma_mttrrnd

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  • MannKind: Do Insider Sales Transactions Indicate This Is A Fool's Rally? [View article]
    I would like to thank the author for giving me an entry point into MNKD. I was hesitant for a while. Thanks. Now riding it till approval :D.
    Jun 12 11:55 AM | Likes Like |Link to Comment
  • Refuting The Latest Negative Blog On Northwest Biotherapeutics [View article]
    Thanks for the response. Actually, I wrote a paper on DC therapy and cancer, and I agree that the approach NWBO is on the cusp of the "personalized medicine" age.

    I know the technology is quite sound - I was just worried at the phrasing of the PR.

    Regarding the Germans - definitely a smart group and they do give me confidence in NWBO.

    Thanks again!
    May 13 01:15 AM | 4 Likes Like |Link to Comment
  • Pozen, Inc.: Buy This Biotech For Growth And Income [View article]
    I really hope it doesn't come to that. I have been long MNKD and DRTX for a while, and got into POZN in April.
    May 13 01:09 AM | Likes Like |Link to Comment
  • Pozen, Inc.: Buy This Biotech For Growth And Income [View article]
    I tried searching, but found a variety of information.

    #1: 2023
    It also asks the court to rule that the earliest date the generic version can be approved by the U.S. Food and Drug Administration "be a date not earlier than the later of Feb. 28, 2023, the expiration date of the last to expire of the patents-in-suit that is infringed and the expiration of any exclusivity relating to such patent to which plaintiffs are or will
    become entitled."
    Source: http://bit.ly/1llli5x

    #2: 2022-2023 For the drug product however, compositions and salts expire between 2015-2020.
    Thus, there is a relatively high chance of postponing generic production. Generics have been approved by FDA, but patent law related oversight still HAS TO approve commercialization. What this means is that you can make it in your lab, you can't sell it yet.
    Source: http://bit.ly/1lllgun

    #3: 2014 BUT keep in mind 80-90% of pharmaceuticals are successful in extending patent to block commercialization. (I personally am ok with extensions, but that's a whole other moral/financial debate altogether).
    "When Will a Generic Version Be Available?
    The first patent for Vimovo is currently set to expire in May 2014. This is the earliest predictable date that a generic version could become available.

    However, other circumstances could come up to extend or shorten this exclusivity period of Vimovo. This could include such things as lawsuits or new patents for specific Vimovo uses."
    Source: http://bit.ly/1lllgup

    #4: This source has a neat graph explaining that 8 patents cover vimovo and 3 expire in 2018.
    Source: http://bit.ly/1lllilT

    #5: 2014-2023
    "The Orange Book lists several patents covering Vimovo
    delayed release tablets. The first of those patents will expire
    on May 27, 2014 and the last will expire on February 28, 2023.

    The Orange Book lists several patents covering Vimovo
    delayed release tablets. The first of those patents will expire
    on May 27, 2014 and the last will expire on February 28, 2023.
    In a suit filed against Dr. Reddy’s, AstraZeneca and Pozen
    allege both direct and indirect infringement of certain claims
    of US patent 6,926,907, which will expire on February 28,
    2023. Pozen is the owner of the patent by assignment and
    AstraZeneca is Pozen’s exclusive licensee. The ‘907 patent
    includes claims directed to the formulation of Vimovo and its
    use in the relief of signs and symptoms of arthritis and riskreduction
    of NSAID-associated gastric ulcer.
    • Dr. Reddy’s Group is among the holders of active DMFs for
    each component of the Vimovo combination."

    Source: http://bit.ly/1lllguv

    Consensus: Even though the generic for Dr. Reddy is approved, there are significant barriers to commercialization. Due to litigation and its lengthy timelines, the generic cannot be produced until after the courts have settled the matter - so we get some time.

    This is strictly my opinion: Furthermore, I can easily see AstraZeneca, Pozen producing modifications to qualify for extensions and/or bar generics on the market until minimum 2018. Vimovo is a good income generator and $AZN is already facing Nexium-generic related issues.

    I hope this answered your inquiries. Presently, my large concern is with FDA and their CRL - I was hoping for an approval and the CRL was highly unexpected.

    On an unrelated note: Given that the same reason was used for another biotech (reason = unsatisfactory 3rd party ingredient maker), I am actually a little bit worried if this will repeat for $DRTX and $MNKD, both of which have great products (I am a recent graduate focused in immunology and pharmacology [not pharmacy]), but I do not have the finance expertise or experience depth with FDA approaches.
    May 11 11:30 PM | 4 Likes Like |Link to Comment
  • Venture Capitalist Ran Nussbaum Brings Big Finance To Little Biotechs [View instapost]
    Thank you! I have been scouring for info on $ARNI, and this is a gem. Just wondering - the company says, "[Arno] will present the objectives, methods and study designs for its two ongoing studies."

    Therefore, since there is no hint of actual results, would ASCO be a catalyst or rather a good entry point?
    May 11 05:01 AM | 1 Like Like |Link to Comment
  • Refuting The Latest Negative Blog On Northwest Biotherapeutics [View article]
    Regarding ASCO - In 2013 the press release touted the space and exposure of DC-VAX technology.

    Quoting the CEO before ASCO 2013: "'ASCO presents a unique opportunity to reach oncologists from throughout the US and around the world with the latest information about our broad DCVax technology for personalized immune therapy treatments for all solid tumor cancers," commented Linda Powers, NW Bio CEO. "Immune therapies have become an area of rapidly growing interest among oncologists, and NW Bio is strongly positioned at the forefront of this emerging new treatment category, with two product lines already at the Phase III clinical trial stage and a third product line at the Phase I/II trial stage. We look forward to raising awareness of our DCVax technology and products with a major exhibit at this year's ASCO meeting.'"

    Quoting the CEO from 2014: "Our increased presence at ASCO this year reflects the progress of our clinical programs with both DCVax-Direct and DCVax-L," commented Linda F. Powers, CEO of NW Bio. "We especially look forward to the opportunity to share information with key opinion leaders and clinicians about our DCVax-Direct technology and Phase I/II trial."

    ASCO 2013, NWBO's PR focused on the space "NW Bio will be participating in the ASCO meeting with a 400 square foot exhibit, located adjacent to the Industry Experts Theater in the Exhibit Hall."

    ASCO 2014: "The Company will also have a large exhibit booth in the ASCO exhibit hall, where further information will be provided about the Company's DCVax technology."

    I just feel who ever is the PR person or even management is not very skilled at providing guidance. They are just rehashing 2013. I looked at the effect of ASCO 2013 on NWBO - nothing changed.

    HOWEVER: Please do note I did find ONE KEY Difference

    2013: DC-VAX broad technology
    2014: DC-VAX Direct and DC-VAX L, with Direct getting a lot more focus and is the newest development.

    I like the product, with my background in science and speciality in immunology, I support the technology and predict a high chance of success. But, I am not satisfied with the released PR, lack of data and the constant focus on overviews of P1/P2. I invite any discussion and hopefully other investors can subside my worries.

    Sources where I took the CEO quotes, and other quotes related to 'size' of exhibits:

    2013: http://prn.to/1jumNz4
    2014: http://prn.to/1mcZ4Uq
    May 11 04:42 AM | 2 Likes Like |Link to Comment
  • Pozen, Inc.: Buy This Biotech For Growth And Income [View article]
    oh man I was waiting for this. Thanks! A few minor hiccups that were unexpected, but I agree with your premise and conclusion on $POZN success potential.
    May 10 10:43 AM | 5 Likes Like |Link to Comment
  • EXAS: Testing Negative For Future Revenue [View article]
    also I would like to add that the science behind EXAS is sound (I do have a background in Science :)) - and its test is no doubt intriguing. The valuations and financials which are a key facet of any product are another dimension that I am learning on.
    Good Luck
    May 1 08:41 AM | Likes Like |Link to Comment
  • EXAS: Testing Negative For Future Revenue [View article]
    For sure - however it is the tone of the entire body and the relatively new account created just to comment on this. Keep in mind, comments are not visible to guests, only to members. Therefore, this means that there is a HIGH CHANCE a member could have created this account. I can easily retort that I am a Medical Director and agree with the author (I am not, and I neither agree or disagree with the author because I do not have a background in valuations).

    Overall, to me this type of commenting pattern is more fitting for Yahoo Message Boards. If the alleged doctor provided citable data refuting any points of this article, I would have given it more credence. I find your comments very detailed and informative, as you have substantial retorts and a quick glance at your profile further solidifies your integrity in my view.

    The purpose of the warning was to advice anyone skimming through the comments to take extra care. I like reading highly commented articles, as I find I learn a lot from them in a relatively short period - hence why I was going through the comments here.
    May 1 08:39 AM | Likes Like |Link to Comment
  • EXAS: Testing Negative For Future Revenue [View article]
    While I do not have a bone in this fight, other SA users please note that this ID has one comment, newly created and given the elementary communication skills, I highly doubt the credentials of colonyt. Furthermore, I find it highly unlikely any self-respecting surgeon would use accusatory language. Good luck to all investors.
    May 1 08:05 AM | 1 Like Like |Link to Comment
  • Why Is Amazon Looking Increasingly Attractive Near $304 [View instapost]
    I agree with your premise especially with the clout $AMZN holds during winter retail season. However, as a small funded investor, I am waiting for a bottom. I think it may go below <300$ pps, and plateau around there until earnings for summer and winter come up in the next year.
    Apr 26 10:05 AM | Likes Like |Link to Comment
  • MannKind's FDA Win Is A Short Seller Massacre [View article]
    I think shorts will start to cover April 8-11 (Tues-Fri). April 14-Monday is a high risk play in my opinion. Overall, I see all engines go for MNKD. (Long MNKD)
    Apr 2 07:29 PM | 2 Likes Like |Link to Comment
  • Behind The Scenes With Dream Team, CytRx And Galena [View article]
    thanks for the response!
    Mar 13 01:56 PM | Likes Like |Link to Comment
  • Behind The Scenes With Dream Team, CytRx And Galena [View article]
    Hi Bryce,

    I really enjoyed your post concerning the timings of GALE pps and its correlations, followed by a SA article by another author who focused on the science of GALE. Overall, its science vs the management in this conundrum.

    Actually, I am just wondering why you would sell your stake today, 3 days before earnings? For sure, the back and forth on SA is tiresome and stagnation of the stock is depressing as well.
    Mar 13 12:36 PM | 2 Likes Like |Link to Comment
  • Pluristem's Preeclampsia Effort Pushes PLX Platform [View article]
    thanks
    Feb 27 06:02 AM | Likes Like |Link to Comment
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