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PVR Partners, L.P. Message Board

bernsteinjoshi 85 posts  |  Last Activity: Apr 22, 2014 12:17 PM Member since: Jun 12, 2013
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  • bernsteinjoshi bernsteinjoshi Apr 22, 2014 12:17 PM Flag

    upppp

  • •RHB-103 likely to be the first thin film triptan to reach the U.S. market

    •Rizatriptan was selected as the drug to deliver via VersaFilm™ because it:
    1.Exhibits the highest efficacy data compared to all triptans
    2.Exhibits the shortest Tmax, indicating rapid onset of action, which is extremely important for
    migraine sufferers
    3.Highly effective in treatment of migraine attacks in children and adolescents. This sub-group
    together with the elderly could greatly benefit from RHB-103

    •The worldwide market for anti-migraine drugs was estimated at approximately $1.9 billion in 2013*,
    of which the sales of triptan drugs, the target market for RHB-103, were estimated at approximately
    $1billion**

    •A broad range of generic triptans are already on the market with prices ranging from $20-$40 perpill (generic versions of sumatriptan,Imitrex® from GSK at ~ $20 and Maxalt® at ~ $35-$40)

    •But the cost of producing RHB-103 is extremely low, thus allowing for very high profit margins

    •An independent patient survey conducted by Brand Institute found that the majority of patients
    would be interested in RHB-103 if it becomes available and indicated that they are likely to ask their
    physician to prescribe migraine medication in an oral film formulation

    •A survey of physicians who treat migraine headaches was conducted and showed that a large
    majority of these would prescribe a film based migraine treatment

    Sentiment: Strong Buy

  • *FDA's letter accepted the bioequivalence study and safety information submitted and requires no additional clinical studies; IntelGenx and RedHill plan to address remaining issues, primarily related to third party manufacturing, packaging and labeling, within weeks based on available data

    *In light of the increased regulatory clarity, IntelGenx and RedHill plan to rapidly advance ongoing discussions with potential partners for the commercialization of their Anti-Migraine "VersaFilm(TM)" Oral Film Product

    *In addition to pursuing marketing approval in the U.S., IntelGenx and RedHill plan to complete the development program for the European market and submit a Marketing Authorization Application later this year

    Sentiment: Strong Buy

  • their paymasters . Dont fall for it . Report These fraudsters and then put on ignore thats the best way to get rid of These #$%$

    Sentiment: Strong Buy

  • bernsteinjoshi bernsteinjoshi Apr 21, 2014 7:39 AM Flag

    Intelgenx wants their own facility for manufacturing of their drugs to save Money thats a fantastic step but this has nothing to do with the dealy or with LTS Lohmann . The Manufacturing Deal with LTS is intact and they must deliver untill IGXT has their own facility . LTS is a german qualitiy Company with around 1200 employees trust me they doing a good Job and the FDA will give their OK very soon .

  • bernsteinjoshi bernsteinjoshi Apr 20, 2014 8:54 PM Flag

    IGXT got the best CRL they can get from the FDA and thats why IGXT has Need only 4 weeks to resolve the issue questioned by FDA and to submit the Response . If the issue were big then they would Need much much more time .

    I think you are just a basher maybe the same Person with the other id called Edward.drossman .

  • Reply to

    Is insulin possible?

    by proofkorea2002 Apr 20, 2014 3:09 AM
    bernsteinjoshi bernsteinjoshi Apr 20, 2014 4:25 PM Flag

    If it works in larger studies then it will be a Mega Blockbuster and it will be much much better than in pills ,injection and inhaled form .I still think that Intelgenx could be aquired by MonoSol because These two companies have the most attractive patents in thin film Technology .
    ---

    Midatech and MonoSol Rx Announce Positive Phase 1 Clinical Results for their Novel Transbuccal Oral Insulin Film Product

    Insulin, stabilized on a nanoparticle and delivered transbuccally, has the potential to offer diabetic patients a viable oral alternative to injectable insulin. The Phase 1 study established Midaform Insulin PharmFilm as a safe, novel, non-injectable insulin delivery system, which closely mimicked the delivery characteristics of monomeric insulin from the pancreas. Importantly, MidaSol’s product showed a faster onset of action compared to subcutaneous insulin. Top-line results, including PK and bioavailability elements, from the study will be presented at the European Summit for Clinical Nanomedicine (CLINAM) in Basel, Switzerland by Prof.Dr. med. Fritz R. Bühler, Chief Medical Officer and member of the Board of Midatech Ltd.

    A. Mark Schobel, Co-President and CEO of MonoSol Rx, said “These results are as good as we could have hoped for in terms of insulin bioavailability and pharmacokinetics following administration of Midaform Insulin Pharmfilm. The rapid onset of action surpassed our expectations and we look forward to further clinical development of this exciting and new groundbreaking product. Based on the success of this in-man study, which unequivocally validates the utility of our diverse pre-clinical animal models, we look forward to accelerating the entire product development program.”

    Sentiment: Strong Buy

  • Reply to

    Still

    by buddude47 Apr 20, 2014 10:55 AM
    bernsteinjoshi bernsteinjoshi Apr 20, 2014 2:14 PM Flag

    Lohmann just manufacturing the drug for igxt thats all. Igxt and redhill will out-licensing the drug to a pharma Company who can market the drug soon once the drug is approved .

  • Reply to

    Still

    by buddude47 Apr 20, 2014 10:55 AM
    bernsteinjoshi bernsteinjoshi Apr 20, 2014 12:02 PM Flag

    First Intelgenx has a manufacturing deal with LTS Lohmann for their versafilm Technology since 2010
    Second Intelgenx already submitted the Response regarding FDA´s CRL in early March means they resolved
    the issues questioned by FDA

    You should do some dd before posting ....
    ---

    1/25/2010 6:13 AM ET

    Monday, IntelGenx Corp. (IGX.V: Quote,IGXT.OB) signed a strategic alliance with LTS Lohmann Therapie-Systeme AG for the exclusive manufacturing of products developed by IntelGenx using its VersaFilm drug delivery technology. VersaFilm is IntelGenx's immediate release wafer technology. It is comprised of a thin polymeric film using United States Pharmacopeia components that are safe and approved by the Food and Drug Administration for use in food, pharmaceutical and cosmetic products.

    Sentiment: Strong Buy

  • bernsteinjoshi bernsteinjoshi Apr 19, 2014 4:00 PM Flag

    Please dont compare SRPT with IGXT because they have a completely New Drug and IGXT has just a better Version of a drug which is available on the Market so the FDA approval will come for sure .

    And the main reason why FDA rejects eteplirsen is that SRPT tested the drug in just 12 Patient,thats to small in this case the fda is right they must do a larger study .

  • This Cannabis drug alone is worth more than $3 per share and could enter the Market within 2 years .There are marijuana scam stocks which have nothing in the pipeline and no cash but valued like IGXT .who has a full pipeline of late stage drugs . GL
    ------

    For pain, the company is developing an AdVersa mucoadhesive dissolving tablet that combines the opioid, buprenorphine, and dronabinol, or THC, which is the active ingredient in marijuana. THC has been approved by the FDA for nausea in cancer patients and is known to be an effective agent for pain management.

    Dr. Zerbe explains that THC is chemically unstable, and as a result, there are no tablet products on the market to replace existing oral sprays and oily solutions. “We have developed patent-protected technology to stabilize the molecule sufficiently to formulate an adhesive tablet, with an oral release and absorption,” he adds.

    He also points out that with the AdVersa delivery system, the bioavailability of THC can be increased and the presence of the psychoactive metabolite reduced, compared with the marketed alternative, Marinol. “The main advantage of the buprenorphine-THC combination is a synergistic effect that leads to a significant increase in pain reduction,” he contends. “We are targeting a very attractive market with a blockbuster potential of $1-billion in sales for various indications such as cancer and neuropathic pain.”

    Sentiment: Strong Buy

  • Reply to

    Why only showing 1 employee? Not bashing

    by jd5216 Apr 15, 2014 2:04 PM
    bernsteinjoshi bernsteinjoshi Apr 18, 2014 7:36 AM Flag

    they have 8 employees not 1 ..Yahoo data most are garbage , you must go to their Homepage or read the sec filings if you want to do your DD .

  • bernsteinjoshi bernsteinjoshi Apr 17, 2014 5:28 PM Flag

    First they sold These Shares (which they bought at 0.40) almost 3 months ago
    Second Zerbe who is the founder still Holding 10.5 M Shares

    Now try something new bashtroll asking always the same questions is very boring

    Sentiment: Strong Buy

  • if i would have such numbers of Shares then i would also sell some after 120% jump like they did .

    Insider Ownership :

    Horst G. Zerbe(1) 4,953,393.5
    Ingrid Zerbe(2) 5,956,356.5
    Bernard J. Boudreau 158,088
    Ian 100,000
    Paul A. Simmons 118,750
    Bernd J. Melchers 125,000
    John Marinucci 37,500

    Sentiment: Strong Buy

  • dont fall for it .look always at their older post to see who is the fake .

    Sentiment: Strong Buy

  • Looks like some big Boys sending their trolls to scare some People just to steal their Shares .

    Sentiment: Strong Buy

  • do some homework before you start bashing

    Sentiment: Strong Buy

  • or earlier . Class1 Review means FDA has maximal 60 days to answer . GL

    Sentiment: Strong Buy

  • Unknown Gem with Brutal Upside Potential ...GLTA

    2 Big Drugs already under review by FDA another 1 NDA filing for "Best in Class" Potency Drug and 1 ANDA filing for CHF will follow within 6 months .

    NDA for anti-migraine VersaFilm(TM) is under review, by FDA. Approval coming any day now .
    (According to Merck's most recent annual report, sales of Maxalt(R) were $638 million in 2012.)

    IntelGenx Announces Submission of ANDA for Buprenorphine/Naloxone Sublingual Film Product for the Treatment of Opiate Addiction
    (According to IMS Health, U.S. retail sales of Suboxone(R) Sublingual Film were approximately $1.5 billion in 2012.)

    Only 20 M on the float ..IGXT has the Potential to hit $10++ within 2 Year ! GLTA

    Intelgenx (IGXT)

    Market Cap : $55 M
    Cash: $5 M
    Price:0.89

    Burn-Rate : $2 M a year
    Shares Out : 63 M ( 31 M shares are held by Investors )

    IGXT´s Monster Pipeline :

    Product ......Application......... Status of Development

    INT0004/2006 Antidepressant -- US launch in 4Q 2012

    INT0008/2007 Migraine -- FDA approval expected for late April or early May

    INT0007/2006 Erectile Dysfunction -- NDA filing in 1H 2014

    INT0001/2004 CHF (Coronary Heart Failure), Hypertension -- ANDA filing in 1H 2014

    INT0027/2011 Undisclosed Partnered with Par Pharma -- ANDA under review by FDA

    INT0020/2010 Insomnia -- in Pivotal Study

    INT0024/2010 Idiopathic pulmonary fibrosis -- in Pivotal Study

    INT0028/2011 Cancer pain (cannabinoid) --in Pivotal Study

    INT0030/2011 Animal health -- in Pivotal Study

    INT0031/2012 Benign prostatic hyperplasia --in Pivotal Study
    ---

    Sentiment: Strong Buy

  • bernsteinjoshi bernsteinjoshi Apr 16, 2014 12:03 PM Flag

    those (Zerbe is founder of IGXT) who sold the 500k Shares are still Holding around 11 Million Shares ,so taking a lil bit Profit after 120% jump is not a bad idea .

    Sentiment: Strong Buy

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