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Vertex Pharmaceuticals Incorporated Message Board

dooom.booom 113 posts  |  Last Activity: 18 hours ago Member since: Mar 12, 2012
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  • dooom.booom dooom.booom Apr 25, 2015 11:39 AM Flag

    read facts !

  • Reply to

    Blrx is still Too high

    by classshopper Apr 21, 2015 2:34 PM
    dooom.booom dooom.booom Apr 24, 2015 3:58 PM Flag

    your momy is slow blowing

  • Adam Feuerstein in not a Analyst or anything else ***Adam Feuerstein mybe an expert of Beer and Wine and ( animal ) Dog research but he knows nothing about Biotech he receive his articles from ( John Tucker )!!! Adam hides behind armor of being a Journalist. he is the servant of the Hedge Fund devils that play the retail investors daily ** Adam Feuerstein is absolutely a tool of the short sellers in biotech. everything he writes comes from them he scare Investors with his Lie´s with his article based on no background later he came out with ethical aspect and more more garbage !! here is another example a self called analyst Adam Feuerstein !! He came out with a article last year from a 25 years old study from a family drugmaker is in "race" to get 3,4-Dap approved before $CPRX -- Jacobus study says it's only in phase II the last 25 years !! ( It won't be hard to find out why it's only in Phase II despite 25 year history !! ) only to remember nothing is for Free !! on goin Phase 2 Study's are not for Free !!! Jacobus need about 25 - 28 Million Dollar for the Phase 2 & Phase 3 Study's !! Study's from Jacobus says their compound is not safe !! this is one of the BIG reason why they are 25 year in Phase 1 b- 2 ! Jacobus received some time WARNING Letters from FDA !! FDA planed to re visit Jacobus 2014 but it BURN *** However **** The FDA personnel carry and periodically employ Geiger counters during their manufacturing facility inspections at Jacobus Pharma *** Firdapse is a Approved drug In Europe and in sales ** Catalyst Pharmaceuticals Partners licensed the North American rights from Biomarin's drug for LEMS *** The FDA granted Firdapse for Orphan drug Status !! Firdapse is in Phase 3 *** Orphan drug status means 7 Years of exclusivity rights *** the growing sales from every quarter from Firdapse from Biomarin $BMRN speak for itself ** Firdapse will be Approved in U.S soon ** Reframing the Catalyst-Jacobus Debate Following up on the recent brushfire debate on Catalyst (Firdapse) and Jacobus (compounded amifampridine), below we highlight data points that may add valuable perspective to investors focused on the LEMS space as the contemplate the true extent of this “competition.” View from Jacobus: manufacturing in a black box. We recently scheduled a call with Jacobus Pharmaceuticals (private) in order to better understand its business model, clinical plan, regulatory strategy, compounding quality control, manufacturing capability and patient outreach. After having first scheduled a time to speak with us, on further reflection, the company’s management cancelled the call, guiding that relevant and sufficient information about Jacobus is already accessible in the public domain. Following their guidance, we redirected our attention to some of the only available sources of information on Jacobus: FDA inspection reports (Form 483) of the company’s Industrial Research Laboratory Building (Schalks Crossing Road, Plainsboro, NJ) from 2011 and 2012. The reports paint a colorful picture of the equipment, quality control, production, and storage at the Jacobus facility, where Dapsone (leprosy tx) and 4-Aminosalicylic acid USP (tuberculosis tx) are also manufactured. The following are representative observations quoted in the report: (a) “procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed”; (b) “there is failure to thoroughly investigate batches that do not meet specification”; (c) “containers used in the production of drug products are not identified at all times”; (d) “facilities used in the manufacturing and storage of components, API, and in-process materials are inadequate”; (e) “equipment used in manufacturing of drug products are not maintained in a state of repair”. The reports also containSchalks Crossing Road. Constructed by the Industrial Nuclear Reactor Laboratories, a consortium of major companies, the conical dome is 87 feet high and made of 18-inch-thick concrete clad in aluminum. It housed a laboratory for low-level atomic research (emphasis added). The reactor became obsolete and was decontaminated, and ownership reverted to the Walker-Gordon Laboratory Company. Today, it houses the offices of Walker-Gordon and the laboratories of Jacobus Pharmaceuticals. (emphasis added). At this time we are unable to ascertain if and how this could affect more stringent manufacturing quality and safety checks from a regulatory point of view, or whether FDA personnel carry and periodically employ Geiger counters during their manufacturing facility inspections at Jacobus Pharma

  • blrx Pipeline worth 1 Billion

    Sentiment: Strong Buy

  • Big Run up expected very soon! !

    Sentiment: Strong Buy

  • Big Run up expected very soon !!

    Sentiment: Strong Buy

  • dooom.booom dooom.booom Apr 16, 2015 10:41 AM Flag

    Pipeline worth
    10
    Times more than current share price ! really not pumping !!

    Sentiment: Strong Buy

  • sounds like a Big Deal

    Sentiment: Strong Buy

  • interesting Move from Big Pharma MYLAN !! something is brewing !!! BioLineRx Out-Licenses Novel Skin Lesion Treatment to Omega Pharma last Year /// Drug Maker Perrigo bought Omega Pharma $4.5 Billion Deal /// NOW Mylan's Move to Acquire Perrigo a Prescription for Success !! Jerusalem, December 23, 2014 – BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today that it has entered into an exclusive out-licensing agreement with Omega Pharma, one of the largest OTC healthcare companies in Europe, for the rights to BioLineRx’s BL-5010, a novel product for the non-surgical removal of benign skin lesions, for OTC indications in the territory of Europe, Australia and additional selected countries. BioLineRx will retain the rights to BL-5010 in the United States and the rest of the world. This licensing agreement significantly accelerates the pathway to commercialization for this asset, with the first OTC products expected to enter the market in 2016.
    Under the terms of the agreement, Omega Pharma will be responsible for all development activities required to obtain regulatory approval in the licensed territory for at least two OTC indications. In addition, Omega Pharma will sponsor and manufacture the product in the relevant regions, and will have exclusive responsibility for commercialization.

    Sentiment: Strong Buy

  • dooom.booom dooom.booom Apr 8, 2015 5:02 PM Flag

    Day's Range: 90.10 - 94.20
    52wk Range: 0.47 - 94.20

  • dooom.booom dooom.booom Apr 8, 2015 12:33 PM Flag

    unrealistic action on Nasdaq Today make no Sense //// BLRX UP on Tel Aviv with a 52 week High

  • dooom.booom dooom.booom Apr 8, 2015 9:26 AM Flag

    according to Roth Capital BioLineRX has a incredible pipeline with a big upside Potential

    Sentiment: Strong Buy

  • dooom.booom dooom.booom Apr 7, 2015 11:37 AM Flag

    BiolineRX BIG Pipeline worth more than 800 Million Dollar

    Sentiment: Strong Buy

  • dooom.booom dooom.booom Apr 7, 2015 11:34 AM Flag

    “With regard to BL-7010, our product for the treatment of celiac disease, we are very pleased with the positive results we reported for the Phase 1/2 safety study completed in the fourth quarter of 2014, including the determination of the optimal safe dose for continued development. We are also very encouraged that the results further support previous preclinical data showing that BL-7010 is not absorbed systemically, which will likely support a medical-device classification and an expedited development pathway for the product in Europe. We are now conducting additional non-clinical studies and formulation development for BL-7010 in preparation for the upcoming efficacy study, which we plan to initiate in the second half of this year.”

    “In December 2014, our partner Bellerophon reached a significant milestone in the development of BL-1040 for the prevention of ventricular remodeling following AMI – the completion of enrollment in the large CE Mark registration trial that has been ongoing for the past three years. We look forward to the top-line results from this trial, expected in mid-2015.”

    “During the fourth quarter of 2014, we announced two significant business development achievements. First and foremost, we entered into a multi-year strategic collaboration with Novartis for the screening and co-development of therapeutic candidates through clinical proof-of-concept. As part of the collaboration, Novartis made an equity investment in BioLineRx of $10 million. We are very excited about the future potential of this collaboration, and view it as a strong validation of our core competencies by a world leader in our industry. In addition, we also announced the out-licensing to Omega Pharma of BL-5010, our skin lesion product, which we hope will begin to provide a royalty stream to us beginning in 2016.”

    “Following the successful completion of our $29 million follow-on public offering earlier this month, we have a strong balance sheet, with enough cash to carry out

  • dooom.booom dooom.booom Apr 7, 2015 11:33 AM Flag

    JERUSALEM--(BUSINESS WIRE)--Mar. 23, 2015-- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, today reported its financial results for the year ended December 31, 2014.

    Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, “2014 marks a year of significant progress for BioLineRx on multiple fronts, both from a product development perspective, as well as from a business perspective. We have continued our focus on the therapeutic areas of oncology and immunology, while increasing the emphasis on our clinical-stage programs.”

    “During the past year, we significantly enhanced and expanded the development strategy for our unique BL-8040 cancer therapy platform across a variety of hematological indications. Results to date from our ongoing Phase 2a clinical study of BL-8040 in relapsed and refractory AML patients continue to show substantial mobilization of leukemic cells from the bone marrow and robust induction of cancer cell apoptosis, as well as excellent safety and tolerability. Top-line results from this study are expected in the second half of 2015. BL-8040 is also in the midst of a Phase 1 safety and efficacy study in stem cell mobilization, with top-line results expected by the end of this month. We eagerly await the data from both of these important studies. In addition, we recently expanded our clinical strategy for BL-8040 to include new clinical trials in three additional hematological indications, all of which are expected to commence by the end of the second quarter of this year. We look forward to executing our comprehensive development plan for this promising treatment platform and to reaching several meaningful value inflection points during 2015.

    Sentiment: Strong Buy

  • get ready

    Sentiment: Strong Buy

  • dooom.booom dooom.booom Apr 6, 2015 7:42 PM Flag

    Biolinerx & Novartis Deal ahead & Sounds like BioLineRX to Russel 2000 index soon

  • Reply to

    BiolineRX added Russel 2000 index !!

    by dooom.booom Apr 6, 2015 10:45 AM
    dooom.booom dooom.booom Apr 6, 2015 3:46 PM Flag

    Big upside potential !! Big Fund's ride BiolineRX to 500 Million Dollar Market soon

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