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Ironwood Pharmaceuticals, Inc. Message Board

galaberge 71 posts  |  Last Activity: Dec 16, 2014 8:48 PM Member since: Mar 5, 2002
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  • Mr. Jeff Riley CEO must stop to talk in such a positive way that people are inclined to invest and be disappointed by numerous delays. He must concretised all what he have said with passion during the last five conferences press releases. We are investors and we demand he keep his word.

    I am confident in the pipeline but I want to see real results. We are in November 2014 and I see nothing that would prevent me from sleeping because I'm too happy about what happens in my company.

    I want results now.

    Long and strong SYN

    Sentiment: Strong Buy

  • During the call, Jeffrey Riley, Synthetic Biologics' Chief Executive Officer, will provide an update on the Company's C. difficile, C-IBS and Pertussis programs, and a review of upcoming milestones for the Phase 2 Trimesta™ program for the treatment of relapsing-remitting multiple sclerosis (MS). C. Evan Ballantyne, Synthetic Biologics' Chief Financial Officer, will review the Company's financial results for the three and nine months ended September 30, 2014.

    Sentiment: Strong Buy

  • galaberge galaberge Oct 31, 2014 4:23 PM Flag

    But Synthetic Biologics has been talking lately about developing Trimesta internally through Phase 3, and then possibly out-licensing it to one of the major players for marketing purposes. I think it makes sense. It wouldn't take that much money to conduct the clinical trials, because Trimesta is not another drug for reducing the number of exacerbations that the MS patients suffer; it's a drug for protecting the positive function of patients who normally experience some decline in cognitive capabilities over time. That is one of the very interesting things that came out of the clinical trials. 3/3

    Sentiment: Strong Buy

  • galaberge galaberge Oct 31, 2014 4:21 PM Flag

    The monoclonal antibodies both bind to the pertussis toxin, but in different locations, to ensure they're capable of knocking out the toxin as quickly as possible and to avoid the potential for a single mutation to render the therapies ineffective.
    The number of individuals who get pertussis is significantly greater outside of the U.S. Worldwide, it killed about 195,000 individuals, largely infants, out of about 16M who were infected in 2013, according to the Centers for Disease Control. This disease really hits developing nations, but it's a disease that could, if left untreated, take the lives of a fairly high number of patients in more developed countries. Synthetic Biologics has a very interesting combination, with an orphan drug here in the U.S., and a major drug in other countries.
    TLSR: Synthetic Biologics has top-line Phase 2 data in hand for its multiple sclerosis (MS) drug, Trimesta (oral estriol). Do you know whether it has begun partnering discussions?
    KM: It's a very competitive market. Players in the MS market, which include BIIB,and Merck KGaA, are the most likely to show an interest in any drug that's new for that particular disease. 2/3

    Sentiment: Strong Buy

  • I quote the interview made in The Life Sciences Report (10/9/14):

    "The risks associated with the stocks we follow are somewhat mitigated by diversification within a company's portfolio."

    TLSR: You also follow Synthetic Biologics Inc. (SYN:NYSE.MKT). I heard CEO Jeff Riley, on a recent earnings call, say he's moving full steam ahead on multiple fronts—multiple sclerosis, anti-infectives, irritable bowel syndrome, pertussis. However, he only has $6–7M in cash on hand. With research and development (R&D) set to ramp up, how will Synthetic Biologics press ahead?
    KM: I would imagine we'll see the company return to the capital markets at some point. I don't know exactly when, but Synthetic Biologics works pretty efficiently, and some of its work isn't going to be that expensive. The balance will be how expensive and how long the clinical trials are going to be versus the number of trials underway at any given time.
    The company's pertussis product will soon begin clinical development. Both Phase 1 and Phase 2 clinical trials are expected to be conducted in 2015, and they won't require huge numbers of patients. The trials also will be—at least the Phase 2—conducted internationally, where the cost will probably be relatively low because there are far more patients with pertussis outside of the U.S. Here in the U.S., pertussis is actually an orphan indication.
    TLSR: What is the specific population that the pertussis candidate is going after?
    KM: It's actually a therapeutic, not a vaccine. The vaccine, diphtheria, tetanus and pertussis vaccine (DTaP), has been around for a long time. One of the problems that developed countries are experiencing is that the bug has been mutating over the years, partly in response to the introduction of vaccines. As a result, vaccines are less effective than 20 to 30 years ago.
    The company is testing a combination of two monoclonal antibodies developed through a collaboration with Intrexon. 1/3

    Sentiment: Strong Buy

  • ........that covers the lead product in its C. difficile program, SYN-004. This is Synthetic Biologics' first allowed patent application directly pertaining to SYN-004 in the U.S. and adds to the Company's extensive C. difficile patent estate.

    "This new patent will strengthen the protection of Synthetic Biologics' SYN-004 and reiterates our position as a key player in the prevention of microbiome-based diseases," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "We continue to bolster the Company's patent estate while making progress towards our goals to initiate Phase Ia and Ib C. difficile clinical trials this quarter."

    This news is is to prepare the IND.

    Long and strong SYN

    Sentiment: Strong Buy

  • galaberge galaberge Oct 20, 2014 7:03 AM Flag

    Don't put the 3 w's at the beginning of the address ! And also be sure to put a "s" because it's a secure address.

    Good luck

    Sentiment: Strong Buy

  • galaberge galaberge Oct 19, 2014 10:34 PM Flag

    the address is :"tallenDOTwebcastsDOTcom/viewer/eventDOTjsp?ei=1043284"

    Sentiment: Strong Buy

  • Reply to

    C-DIFF // Price Targets

    by mdr0418 Oct 18, 2014 10:29 AM
    galaberge galaberge Oct 18, 2014 1:05 PM Flag

    There are 5,723 hospitals in the U.S.

    Sentiment: Strong Buy

  • Reply to

    C-DIFF // Price Targets

    by mdr0418 Oct 18, 2014 10:29 AM
    galaberge galaberge Oct 18, 2014 12:34 PM Flag

    SYN-004 will go fast track because and I quote "The U.S. Centers for Disease Control and Prevention (CDC) has classified harmful and potentially deadly C. difficile as an "URGENT PUBLIC HEALTH THREAT," surpassing Methicillin-resistant Staphylococcus aureus (MRSA) as the number one hospital-acquired infection in the United States."

    We already know that Phase 1 and 2 studies in Europe of a first-generation version of SYN-004 involving 200 subjects demonstrated safety, tolerability and preservation of the normal GI microflora.

    Moreover we have the following schedule ahead of us:

    1-First, the Company has already entered into an agreement with Evonik for oral formulation development, analytical services, and clinical drug manufacturing in accordance to GMP guidelines, of the Company's proprietary oral beta-lactamase enzyme, SYN-004, for use in the planned clinical trials. Evonik plans to formulate and encapsulate enterically coated SYN-004 for oral delivery using material generated by Synthetic Biologics' API manufacturer FUJIFILM Diosynth Biotechnologies UK Limited.

    So we have the manufacturing capabilities to supply the healthcare system.

    2-Second, we should have the ongoing canine toxicology study next week.

    3-Third, as you say IND will be filed for C-diff next week and trials will begin in 30 days.

    4-Fourth, the company expects in the fourth quarter of 2014 the preliminary Phase Ia and Ib clinical studies.

    5- The Company expects to start Phase II efficacy study of SYN-004 and get topline results in the first half of 2015

    So IMO we should be in business very early next year and I expect a PPS of $20 assuming Trimesta results in Q1-2015 will be as good as I think (MRI analysis positive for cognition)

    Long and strong SYN

    Sentiment: Strong Buy

  • galaberge galaberge Oct 18, 2014 7:13 AM Flag

    Ugt-Sorry but your text is totally incomprehensible. Could you be clearer please ? Thanks.

    Sentiment: Strong Buy

  • Reply to

    More Trimesta Data....

    by tina_bridgett50 Oct 16, 2014 7:58 PM
    galaberge galaberge Oct 16, 2014 8:43 PM Flag

    Tina-I think you're a brave woman. Dr. Voskuhl will confirm what you are saying....but it will require additional several weeks to carefully analyse each MRI for the 164 women recruited with relapsing-remitting MS at 16 sites across the U.S. You know MRI's require a huge amount of computer number-crunching to extract the images from the raw data; we have to understand that Dr. Voskuhl has maybe 700-800 MRI to analyse (before the test, during the test, at the end of the test...) and she has to do a lot of homework to calculate , the median, the mean, the % of reduction....and so on.

    Dr. Voskuhl has worked all her life on that MS disease and she knows the truth and she wants to make a success of her report for the health of THOUSANDS OF PATIENTS. She doesn't want to miss the boat.

    So I expect the final report by Q1-2015 and a finally Estriol as the cure for MS

    Stay tuned and your point of view will prevail.

    Long and strong SYN

    Sentiment: Strong Buy

  • galaberge galaberge Oct 16, 2014 6:19 PM Flag

    I tend to agree strongly with you.

    In my DD I have found this:

    "Gastrointestinal (GI) diseases affect an estimated 60 to 70 million US citizens annually. In 2004, there were an estimated 4.6 million hospitalizations, 72 million ambulatory care visits, and 236,000 deaths attributable to GI disease. Spending on GI diseases in the United States has been estimated at $142 billion per year in direct and indirect costs."

    The Synthetic Biologics' mngt has made a good choice in targetting C.Diff. and the other disorders with the the product SYN-004

    For the complete article here is the link :"medscapeDOTcom/viewarticle/774795_1"

    Long and strong SYN

    Sentiment: Strong Buy

  • I quote the CEO J. Riley:

    "September 2, 2014

    The Company is in the final stages of preparing its SYN-004 IND application for submission to the FDA, with the expectation of initiating Phase Ia and Ib clinical trials in the fourth quarter of 2014, and a Phase II efficacy study in the first half of 2015.

    "As the need for a preventative for C. difficile infections continues to increase globally, moving our SYN-004 program toward the clinic is more important than ever," stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "SYN-004 is unique from other C. difficile preventative approaches in development, as it is designed to protect and maintain the microbiome, and prevent the proliferation and devastating effects of C. difficile infections. Research continues to demonstrate that protection of the microbiome also plays an increasingly important role in the PREVENTION OF A VARIETY OF GI, METABOLIC and CNS DISORDERS"

    "Mr. Riley concluded, "In addition, SYN-004 is provided only when necessary – as a patient receives IV antibiotics and is at greatest risk of developing C. difficile. Synthetic Biologics' point-of-care preventative approach contrasts significantly with approaches that require mass vaccination."

    So SYN-004 is protecting the microbiome to prevent many other disorders.....!

    Link : "news-medicalDOTnet/news/20140902/Synthetic-announces-positive-results-from-final-preclinical-toxicology-study-of-SYN-004DOTaspx"

    Long and strong SYN

    Sentiment: Strong Buy

  • So we are in a very good shape even with a market's correction !

    Long and strong SYN

    Sentiment: Strong Buy

  • The C-IBS CAB, chaired by Mark Pimentel, M.D., Director of the GI Motility Program and Laboratory at Cedars-Sinai Medical Center, is strengthened by the addition of 4 new members. The valuable guidance provided by the C-IBS CAB has focused the clinical development of SYN-010, which is anticipated to initiate a Phase II clinical trial in C-IBS during the first half of 2015 under a corporate Investigational New Drug (IND) application, with topline data expected in mid-2015.

    Read the full PR

    Long and strong SYN

    Sentiment: Strong Buy

  • Reply to

    Warrants

    by fueltheobsession Oct 13, 2014 6:48 PM
    galaberge galaberge Oct 13, 2014 7:08 PM Flag

    Read the "Form 424B5-Synthetic Biologics, Inc. - SYN----Filed: October 10, 2014-Prospectus filed under Rule 424(b)(5)" and you find the answer.

    It's NO !

    I quote :

    "We do not intend to apply for listing of the warrants on any national securities exchange or for inclusion of the warrants in any automated quotation system. The warrants will be issued in physical form."

    Long and strong SYN

    Sentiment: Strong Buy

  • galaberge galaberge Oct 13, 2014 5:11 PM Flag

    Presently we have 58.45M shares outstanding. If we add the new 14.06M shares it equals to 58.45 + 14.06 = 72,51M shares x $1.39 pps(actual) = $100,8 Market Cap. as of today. One day we will include the 7 M shares coming from the warrants ...when exercised.

    Sentiment: Strong Buy

  • galaberge galaberge Oct 13, 2014 4:05 PM Flag

    Read the "Form 424B5 Synthetic Biologics, Inc. - SYN- Filed: October 10, 2014
    Prospectus filed under Rule 424(b)(5)" at page S-8

    "We estimate that the net proceeds of this offering, after deducting the placement agent’s fees and the estimated offering expenses payable by us, will be approximately $18.9 million excluding proceeds, if any, from the exercise of the warrants issued in this offering."

    So we have $18.9M and a remaining cash balance od approx. $3M = $22M !

    The exercise of the warrants will be done when we will be well over $1.75 PPS and it will give an additional 14,059,616 X 0.5 share X $1.75 = $12.3M !

    I have not included these warrants in my calculations as it's not tangible right now. One day we will have to include this amount but not now.

    I hope I answer your concern. Have a good day

    Long and strong SYN

    Sentiment: Strong Buy

IRWD
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