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Synergy Pharmaceuticals, Inc. Message Board

galaberge 127 posts  |  Last Activity: 7 hours ago Member since: Mar 5, 2002
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  • galaberge galaberge 7 hours ago 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 16 hours ago 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

  • We have on hands $22M ($18.9 from the recent offering + $3M remaining in the company) so we could be in a very good position to advance our pipeline for at least 18 months.

    Good move from the CEO Riley.

    Long and strong SYN

    Sentiment: Strong Buy

  • galaberge galaberge Oct 13, 2014 12:41 PM Flag

    This financing was allocated to both existing and new investors, including lead investor Great Point Partners, LLC.

    Sentiment: Strong Buy

  • Reply to

    Next steps for SYN 004 and for SYN 010

    by galaberge Oct 11, 2014 6:51 PM
    galaberge galaberge Oct 12, 2014 8:18 PM Flag

    There is no machine existing now to disinfect rooms, and all the corridors in a hospital. Just read and listen to the following : http://news.yahoo.com/germ-zapping-robots-hospitals-combat-superbugs-140922678.html
    Many manufacturers are trying different robots but none works as it's required in a hospital.
    So having a simple pill to protect the microbiome is highly welcome. It's impossible to disinfect a room due to too much different material inside a room retaining the spore of the C.Diff. ! It needs only 1 spore to infect you if you are not already infected naturally. If naturally infected, your well balanced microbiome in your body will keep it inoffensive; but going to hospital and having IV antibiotics will imbalance your microbiome instantly and you will become awfully sick due to the release of toxins of C.Diff. not neutralised by a healthy microbiome. Once you get C.Diff. it's quite a challenge to become again healthy with a microbiome well balanced. We have in US 14,000 death in hospital and everybody tries to find a solution.
    SYN-004 will go after the C.Diff, toxins and will neutralize them and will help to restore your microbiome and you will be cured in a day or two.

    For SYN-010 (constipation-predominant IBS (C-IBS), Mark Pimentel, MD, Director of the GI Motility Program and Laboratory at Cedars-Sinai Medical Center and Chairman of Synthetic Biologics' C-IBS Clinical Advisory Board, described SYN-010 has MODIFIED RELEASE formulation of a classical statin that is optimal for reducing methane-production by certain microorganisms (Methanobrevibacter smithii) in the gut while avoiding systemic drug absorption. Methane produced by these organisms is perceived as the underlying cause of bloating, pain and constipation associated with C-IBS, and may contribute to the pathology of other diseases. SYN-010 is intended to treat the "core" cause of C-IBS, not just the symptoms.

    Sentiment: Strong Buy

  • Based on the prospectus filed pursuant to Rule 424(b)(5) dated 10/10/2014

    "In addition, adjunctive oral Trimesta plus injectable standard of care Copaxone ® demonstrated a strong safety profile and was well tolerated by women in the study. Further analyses of the MRI data are ongoing, with TOPLINE DATA expected during the FIRST QUARTER OF 2015. This investigator-initiated clinical trial is supported by grants exceeding $8 million, awarded primarily by the National Multiple Sclerosis Society (NMSS) in partnership with the NMSS’s Southern California chapter, and the National Institutes of Health. Annual worldwide sales of MS therapies are forecasted to be $17.8 billion in 2019. We have licensed from UCLA issued method of treatment patents in the U.S. for MS therapy with estriol and estriol combination therapies (including estriol with Copaxone ® ), and four new provisional patent applications have been filed based on these recent Phase 2 clinical results. We are engaging with the neurology community and potential strategic partners, as we determine next steps for Trimesta."

    Long and strong SYN

    Sentiment: Strong Buy

  • Reply to

    Next steps for SYN 004 and for SYN 010

    by galaberge Oct 11, 2014 6:51 PM
    galaberge galaberge Oct 12, 2014 2:03 PM Flag

    Patients EXCLUDED from the study were those that had immunosuppression (acute leukemia, history of hematopoietic stem cell transplantation, cytotoxic chemo within 2 months, or neutrophil count minus1000/uL, a history of irritable bowel disease or irritable bowel syndrome with diarrhea, a total colectomy, liver cirrhosis, the NEED FOR ANTIBIOTICS WITHIN 6 WEEKS, prior fecal microbiota transplantation or Intensive Care Unit admission or were pregnant or nursing."

    With SYN-004 we have NO restriction based on the first clinical trial because its enzyme properties.

    Check the full article :"prnewswireDOTcom/news-releases/seres-health-presents-final-data-for-study-of-ser-109-in-recurrent-clostridium-difficile-infection-at-icaac-2014-conference-274361241DOT"

    Sentiment: Strong Buy

  • Reply to

    Next steps for SYN 004 and for SYN 010

    by galaberge Oct 11, 2014 6:51 PM
    galaberge galaberge Oct 12, 2014 2:00 PM Flag

    Difficult sometimes to post : I am deleted !.

    Anyway I try again :

    "Patients EXCLUDED from the study were those that had immunosuppression (acute leukemia, history of hematopoietic stem cell transplantation, cytotoxic chemo within 2 months, or neutrophil count

    Sentiment: Strong Buy

  • Reply to

    Next steps for SYN 004 and for SYN 010

    by galaberge Oct 11, 2014 6:51 PM
    galaberge galaberge Oct 12, 2014 1:50 PM Flag

    jrdelane- If you read the full article you will note the followings: "Patients included in the study were between 18 and 90 years old, had greater than or equal to 3 laboratory-confirmed CDI episodes over 1 year, had a life expectancy 3 months and were able to give informed consent. Patients EXCLUDED from the study were those that had immunosuppression (acute leukemia, history of hematopoietic stem cell transplantation, cytotoxic chemo within 2 months, or neutrophil count

    Sentiment: Strong Buy

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