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Ironwood Pharmaceuticals, Inc. Message Board

galaberge 498 posts  |  Last Activity: Dec 16, 2014 8:48 PM Member since: Mar 5, 2002
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  • ....held by the Infectious Diseases Society of America (IDSA), October 8-12, in Philadelphia, PA.

    I quote :

    "•SYN-004 differs from its parent enzyme, P1A, by one amino acid, D276N

    •SYN-004 displayed improved degradation of a panel of cephalosporin, including ceftriaxone

    •Manufacturing of SYN-004was optimized to obtain high yields with simplified purification

    •Enteric-coatedSYN-004pellets are inert at low pH and rapidly dissolute at pH’s 5.5

    •Enteric-coated SYN-004 pellets rapidly dissolute in human chime and display stable activity for
    at least 4 hours

    •In dogs, oral delivery of SYN-004 pellets resulted in efficient degradation of intestinal CRO

    •Clinical evaluation of SYN-004 is anticipated in to begin in late 2014"

    See the link for the poster : " idsaDOTconfexDOTcom/idsa/2014/webprogram/Paper46546.html "

    So we should have in few days the positive results of the Phase 1a and 1b

    Long and strong SYN

    Sentiment: Strong Buy

  • galaberge galaberge Dec 14, 2014 11:14 PM Flag

    Ugt - Nice post. Well summarized. Now let's hope Riley will take few minutes to read our posts and brings some clarification in order to maintain the PPS stable and coherent with our pipeline.

    Long and strong SYN

    Sentiment: Strong Buy

  • What a loss of time from your part. The truth will always prevail with the longs. Have a nice evening...with your thumbs down !!!!

    Sentiment: Strong Buy

  • galaberge galaberge Dec 14, 2014 1:36 PM Flag

    Riley as a CEO said something on the 14th November 2014 to an analyst who will follow his performance and may have a great influence on the SYN's stock. 2 weeks later Riley is saying a complete different story : 40 person instead of 12-20, and 1a by year-end instead of 1a AND 1b by year-end ! When a CEO is saying lies in a 2 weeks period, he lost his credibility.

    Also where do you take the fact that 1b will be at the end of January to early Feb 2015? I have learnt to be honest and this kind of behaviour from Riley undermines his credibility and gives ammunitions for the bashers.

    Sentiment: Strong Buy

  • galaberge galaberge Dec 14, 2014 1:03 PM Flag

    It's another thing why Riley has lost confidence from the future buyers and the actual shareholders ! The phase 1a AND 1b were due BY YEAR-END 2014 as per the follwing answer to a question of an analyst. I quote :

    "Daryl Weber - Wells Fargo Advisors, LLC.
    Good morning, gentlemen. So a couple of questions here; with respect to your Phase 1 and Phase 1a and Phase 1b for C. diff; how many patients are you anticipate enrolling? And the top line data you will be reporting by year end, now what would that entail? And will it be for all the patient cohort? Thank you.

    Jeff Riley - President and CEO
    Thanks for the questions, Daryl. To answer your first question the Phase 1a and 1b will be between 12 and 20 patients. We’re looking for safety in these, and obviously we’re doing a dose response as well. These are in normal patients and these are very, very quick studies. Really look and see what's happening in both genetically as well as PK/PD profiles of these patients. And as we said, we should have data from that by the end of this year."

    See the link : "Synthetic Biologics' (SYN) CEO Jeff Riley on Q3 2014 Results - Earnings Call Transcript "

    Sentiment: Strong Buy

  • Based on the PR of SYN we should get !a AND 1b before year-end 2014. Check the link :" syntheticbiologicsDOTcom/2014-11-24-Synthetic-Biologics-Safe-to-Proceed-Under-IND-to-Initiate-Clinical-Trials-of-SYN-004-for-the-Prevention-C-difficile-Infection "

    Sentiment: Strong Buy

  • Phase 1

    The initial phase of testing of an investigational drug in humans. Usually a hase 1 clinical study is conducted in a small number of healthy volunteers or patients with a disease for which the drug may be useful. Generally, the study is designed to determine the side effects of the drug and its pharmacokinetics. Some information regarding drug efficacy may be collected if patients with a disease participate. A phase frequently encompasses more than one clinical trial.

    Phase 1 sometimes is sub-divided into Phases 1a and 1b, for example when the first set of Phase 1 trials (Phase 1a) is performed in healthy volunteers and a second set of Phase 1 trials (Phase 1b) is performed in patients with a disease.

    Check the following link : " bloomingrosefoundationDOTorg/wp-content/uploads/2009/10/Glossary-of-Clinical-Trials-TermsDOTpdf "

    So we will have efficay results for patients with the C.Difficile disease.

    Long and strong SYN

    Sentiment: Strong Buy

  • The oral enzyme candidate SYN-004 is intended to protect the GI tract from the overgrowth of C. difficile. Watch the full video to learn more! :" youtubeDOTcom/watch?v=jvnH_Yipo1c "

    Sentiment: Strong Buy

  • Don't eat too much turkey and listen to alot of football

    Long and strong SYN

    Sentiment: Strong Buy

  • galaberge galaberge Nov 24, 2014 6:22 PM Flag

    To answer your question here is what SYN has written on their website :

    I quote :

    "Anticipating a 505(b)(2) regulatory pathway for SYN-010, a corporate Investigational New Drug (IND) application is expected to be filed with the FDA in the first quarter of 2015 with the initiation of a Phase 2 clinical trial of SYN-010 in C-IBS anticipated in the first half of 2015"

    2015 will be THE year of Synthetic Biologics !

    Long and strong SYN

    Sentiment: Strong Buy

  • galaberge galaberge Nov 24, 2014 8:40 AM Flag

    They just say again "Synthetic Biologics plans to begin Phase 1a and 1b clinical trials shortly, with topline data expected to be reported before year-end."

    So I have no doubt we will have the results soon.

    Long and strong SYN

    Sentiment: Strong Buy

  • Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that its Investigational New Drug (IND) application which was submitted to the U.S. Food and Drug Administration (FDA) in October will be proceeding into clinical trials for the development of the Company's oral beta-lactamase enzyme SYN-004 for the prevention of Clostridium difficile (C. difficile) infection (CDI), antibiotic-associated diarrhea (AAD) and secondary infections with healthcare-acquired, drug-resistant pathogens in patients receiving intravenous (IV) beta-lactam antibiotic therapy. Synthetic Biologics plans to begin Phase 1a and 1b clinical trials shortly, with topline data expected to be reported before year-end.

    "We are pleased the FDA completed the 30-day review of our IND and to be initiating clinical trials of the first potential point-of-care preventative therapy for C. difficile, the CDC's top-ranking public health threat," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "Taking immediate and aggressive action to develop a therapy that can prevent C. difficile before it starts is critical in addressing this pervasive and life-threatening infection, and IND activation for SYN-004 is a key step toward the development and eventual commercialization of therapy to protect the millions of at risk U.S. patients."

    Long and strong SYN

    Sentiment: Strong Buy

  • galaberge galaberge Nov 18, 2014 2:20 PM Flag

    I think it will go to 1 cent ! Is it enough for you id..#$%$ ?

    Long and strong SYN

    Sentiment: Strong Buy

  • Here is the link :

    "seekingalphaDOTcom/article/2683225-synthetic-biologics-syn-ceo-jeff-riley-on-q3-2014-results-earnings-call-transcript?app=1&uprof=44"

    Long and strong SYN

    Sentiment: Strong Buy

  • Reply to

    RJK and intrexon as a big brother

    by e.solimine Nov 14, 2014 7:34 PM
    galaberge galaberge Nov 14, 2014 11:01 PM Flag

    SYN and Intrexon's (XON) CEO Randal Kirk on Q3 2014 Results - Earnings Call Transcript

    FYI just check the following transcript address :

    "seekingalphaDOTcom/article/2681305-intrexons-xon-ceo-randal-kirk-on-q3-2014-results-earnings-call-transcript?part=single"

    Daryl Weber of Wells Fargo was at the XON CC and newly at the SYN CC !!!

    See the transcript of XON to understand better what's going on on these 2 sister's companies

    Long and strong SYN

    Sentiment: Strong Buy

  • Reply to

    Tina is absolutely NOT late in updating our MB.

    by galaberge Nov 12, 2014 7:30 PM
    galaberge galaberge Nov 12, 2014 8:21 PM Flag

    She is not on placebo. She is taking Estriol compound for 1 year or so. BTW for your info, ask the Harvard Medical School for the normal delay for a MRI in MS.........

    Long and strong SYN

    Sentiment: Strong Buy

  • Telling the contrary means we don't understand the complexity of a MRI evaluation of a MS brain's patient.

    When we take a MRI for evaluating the MS damages in the brain or to see improvement we have to remember that If the images are stored in and displayed by a computer, there is no time required to develop the images, although the doctor's interpretation still takes time. You can probably get preliminary results within a day or two, but the complete results might take four to seven days. In fact, usually 4-7 days is the normal delay. Also you have to remember that Tina is not the only person in this hospital with MS.

    So PATIENCE is required.

    It's the reason why Dr. Voskuhl will give us the complete analysis of the 158 women only in Q1-2015 . It's quite a job, needing a lot of work to present a thorough report well documented.

    Long and strong SYN

    Sentiment: Strong Buy

  • galaberge galaberge Nov 12, 2014 5:23 AM Flag

    This is not the place for those playing the role of psychologists, psychiatrists, and everyone disconnected from reality. This is not the place also for those who have no share and insult people. Here is an message board for people who have an interest in business and want to share their point of view either technically or financially. So go play with your little friends in kindergarten.

    Long and strong SYN

    Sentiment: Strong Buy

  • After all it's the last CC of Riley this year and he must announce all what we were supposed to have in H2-2014 many times this year “(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 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)....etc”

    It’s so late I expect nothing but the usual blablabla of a man late on schedule.

    But…if we get good news, I say real good news it can push the stock back to $2.50 before to enter the H1-2015. But the stock price is not really an issue. It's the execution of the action plan which is posing problems; maybe not enough manpower to run all the various products in the pipeline.

    I hope Randal J. Kirk will be more involved in 2015.

    I strongly believe in the pipeline of SYN

    Long and strong SYN

    Sentiment: Strong Buy

  • Reply to

    Now it' time to deliver the merchandise.

    by galaberge Nov 6, 2014 7:58 PM
    galaberge galaberge Nov 7, 2014 12:21 PM Flag

    I had great respect to you mdr0418 and I have told many times this fact. But before I can answer your point you insult me with your statement " You sound like a 2 year old in the back seat yelling at your mom for your bottle". Sorry but the respect I had for you is gone. Do your own DD and count the number of times Riley has not done what he was telling. Even your own predictions were wrong because you have been wrongly interpreting Riley's words.

    So keep your insults for yourself. I don't need your comments anymore.

    Long and strong SYN

    Sentiment: Strong Buy

IRWD
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