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AmSurg Corp. Message Board

redeyesurfer 9 posts  |  Last Activity: May 27, 2016 4:32 AM Member since: Apr 14, 1998
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  • redeyesurfer redeyesurfer May 27, 2016 4:32 AM Flag

    Part. 2

    Long: The body of Merle Haggard was recently exhumed and given a shot of Soli.
    Within 5 minutes he was on the phone to his agent planning his "Merle Haggard:
    Back From The Grave" tour.
    Short: It doesn't matter.

    Long: Cempra signs European and rest of the world, minus the U.S. and Asia, partner
    with excellent milestone and royalty prospects.
    Short: It doesn't matter.

    Long: Soli gets FDA approval.
    Short: It doesn't matter.

    Long: Soli gets EU approval
    Short: It doesn't matter.

    Long: Soli gets Japanese approval.
    Short: It doesn't matter.

    Long: Soli surpasses both company and analyst sales guidlines for the first full
    quarter of reported sales.
    Short: It doesn't matter.

    Long: Anecdotal reports slowly filter in about cases where Soli is working when
    other antibiotics are having great difficulties.
    Short: It doesn't matter.

    Long: Soli is approved for the indication of Gonorrhea.
    Short: It doesn't matter.

    Long: Soli gets Cystic Fibrosis indication approval.
    Short: It doesn't matter.

    Long: Soli gets COPD indication approval.
    Short: It doesn't matter.

    Long: Soli gets NASH indication approval.
    Short: It doesn't matter.

    Long: The U.S. government says it will maintain a stockpile of 5 million doses of
    Soli for use against bioterrorism.
    Short: It doesn't matter.

    Long: Cempra spurns 100% takeover premium in unsolicited offer, telling the would-be
    suitor to "pound sand" because we're worth multiple times that much.
    Short: It doesn't matter.

    Long: The short in this exchange begrudgingly takes Soli to recover from a near death experience when no other antibiotic would work.
    Short: It doesn't matter.
    Long: How can you say it doesn't matter??? Soli just saved your life.
    Short: It doesn't matter because I'm now broke because of my short position in Cempra. I'll probably just max out my credit cards in one last hurrah and then jump out a window anyway.

  • Tongue in cheek ongoing/future (forward looking liberties taken) conversation with a short

    Long: Soli just completed an outstanding Phase 3 oral trial.
    Short: It doesn't matter.

    Long: Soli just completed an outstanding Phase 3 IV trial.
    Short: It doesn't matter.

    Long: Soli has a better overall safety profile than other macrolides.
    Short: It doesn't matter.

    Long: Soli interacts with 3 sides of the bacterial ribosome causing it to be both
    much more effective and much more resistant to bacterial resistance.
    Short: It doesn't matter.

    Long: Fluorquinolones are maiming countless numbers of people.
    Short: It doesn't matter.

    Long: Large numbers of "Floxed" people showed up at an an FDA hearing railing
    against Fluoroquinolones and the oftentimes irreversible harm they have caused
    to their bodies.
    Short: It doesn't matter.

    Long: The FDA warns about the dangers of using Fluoroquinolones in uncomplicated
    infections.
    Short: It doesn't matter.

    Long: The FDA orders Fluoroquinole labeling changes because of their side-effects.
    Short: It doesn't matter.

    Long: Cempra partner Toyama in Japan anniliates Levoquin in a Soli vs. Levo Phase 2
    trial.
    Short: It doesn't matter.

    Long: Demographic aging trends point to increasing rates of pneumonia in the
    populace and therefore more need for a safe and effective macrolide
    antibiotic.
    Short: It doesn't matter.

    Long: A review in the UK says the need for more antibiotics is so dire that a reward
    of between 1 and 1.5 billion should be given to drug companies who manage to
    bring new antibiotics to market.
    Short: It doesn't matter.

    Long: A report out of the UK says that by 2050 superbugs will kill more people than
    cancer.
    Short: It doesn't matter.

  • Look for the usual suspects to be out in full force on the board today poo-pooing the NDA's. These NDA's came a full 4-6 weeks before most people were expecting and I'm sure will be highlighted to great degree by management during the conference call. Had the NDA's came 6 weeks from now the shorts might have pulled off a sell on the news/expected/typical/nothing to see here/already priced in type of trading environment. That's now not going to happen. We won't be up huge on this, but it's earlier than expected so it should be a very nice day.

  • Reply to

    Lots of pumping...

    by pharmajedi Apr 15, 2016 12:57 PM
    redeyesurfer redeyesurfer Apr 15, 2016 6:53 PM Flag

    You know full well that the *possible* monitoring being speculated about in a few random news articles only pertains to the IV form of soli and not the pill form. Quit making stuff up. Bash if you will but stop spouting nonsense.

  • Conclusions, Applications, and Future Research Directions

    We believe solithromycin has exciting potential for the treatment of intrauterine infections, prevention of preterm birth, and also treatment of perinatal and postnatal infections. Its pharmacodynamic and pharmacokinetic properties are ideally suited to these applications, and our data on transplacental passage and AF accumulation suggest that this antibiotic may represent a major advance in antimicrobial therapy in pregnancy.

    There are three main obstetric scenarios where solithromycin therapy may be particularly beneficial. The first is in the prophylactic treatment of asymptomatic women at high risk of preterm birth in the first half of pregnancy. The strategy requires the ability to identify women who are at risk of intrauterine infection and, thus, target them for solithromycin treatment (35). Prognostic indications, in addition to standard clinical risk factors, could be abnormal vaginal microbiota or presence of particular microbial profiles or species (15, 16, 111–113), or a short cervix with evidence of inflammatory changes (114–116). The second situation is in women with PPROM. In these pregnancies, macrolides have been shown to have significant benefits in terms of neonatal outcomes (117); with its far superior efficacy profile and ability to treat the fetus in utero, it is likely that solithromycin would be much more beneficial than erythromycin for this indication. Finally, solithromycin may be effective in improving neonatal outcomes in women presenting with preterm labor and intact membranes, providing both antimicrobial and anti-inflammatory benefits to the fetus prior to delivery. In all of these scenarios, co-administration with a more potent anti-inflammatory agent may further improve outcomes. Clinical trials to explore all of these applications are warranted, once pharmacokinetic studies have been conducted to establish safe and effective dosing regimens in early, mid, and late pregnancy. Assessment of the short- and long-term effects of antenatal solithromycin therapy on the vaginal, gastrointestinal, and neonatal microbiomes would also be warranted prior to trials of its therapeutic effectiveness in pregnancy.

  • Authors: Copyright: © 2016 Jeffrey Keelan, Mathew Payne, Mathew Kemp, Demelza Ireland and John Newnham.

    (Publication date April 1, 2016)

    This is a quite lengthy article which is mostly positive in regards to the possible use of Solithromycin for the indications of intrauterine infections, prevention of preterm birth, and also treatment of perinatal and postnatal infections. In short things, look promising on paper and in animal testing but of course a lot more testing would be needed to flesh out these indications. I'll post the authors conclusions below, but any true Cempra junkie should go and read the entire article. Just Google "Frontiers In Immunology" and then enter the search term Solithromycin into the search field on their home page.

    Author conclusions are below:



    I'll post the rest of the author conclusions shortly in Part 2.

  • Cowen and Company analyst Ritu Baral shares an update on biotechnology company Cempra following its Solitaire-IV presentation at ECCMID conference in Amsterdam. The analyst reiterated an Outperform rating and provided a target price of $39.

    At the ECCMID conference, Cempra’s drug Solitaire-IV showed “solid efficacy and no real surprise on safety.” Solitaire-IV is an antibiotic used to treat bacterial pneumonia. Baral expects “LFT [Liver Function Tests] fluctuations present only in the IV study to be the only major point of FDA scrutiny (and AdComm discussion) for the upcoming NDA.” Further, the analyst sees a high likelihood that U.S. and EU agencies would approval the drug.

    Following the medical trial, Baral expects liver safety to be the key discussion point, though notes that the drug’s “liver safety profile is far from a barrier to approval.” Key opinion leaders echo Baral’s views, believing that as long as liver enzyme fluctuations are “mild, reversible and transient, the safety concern would be addressable with monitoring.” Further, Baral writes that “liver enzymes for hospitalized patients already on IV drops are easily monitorable if nothing else.”

    Lastly, Cempra shared that they will have a pre-NDA meeting before submission completion and have already had scientific meetings with EMA (European Medicines Agency) to discuss their Solithromycin Oral and Solitaire-IV, both treatments for bacterial pneumonia. Baral thinks both phase 3s have met their primary endpoint of non-inferiority and have acceptable risk/benefit safety profiles. Key opinion leaders, according to Baral, have “no concerns on efficacy, and are cautiously optimistic on safety.”

  • Reply to

    IF

    by downandoutinaguilas Mar 30, 2016 3:48 AM
    redeyesurfer redeyesurfer Mar 30, 2016 2:34 PM Flag

    Prabha often mentioned flu season when talking about Soli during the clinical trials. This is because although flu is indeed caused by influenza viruses, having the flu often time leads to also having bacterial pneumonia.

  • Reply to

    Thoughts on Betrixaban Phase III

    by redeyesurfer Mar 28, 2016 6:01 AM
    redeyesurfer redeyesurfer Mar 30, 2016 1:41 AM Flag

    Mainly I was working off of the conference call on my "a LOT less bleeding" comment. At around the 31:20 mark they said "we thought we were going to see a 30-40-50% increase in major bleeding."

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