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AFC Enterprises, Inc. Message Board

beepeeess 51 posts  |  Last Activity: 14 hours ago Member since: Oct 10, 2012
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  • Enough is enough

  • Reply to

    What the Hell?

    by beepeeess Aug 19, 2014 4:54 PM
    beepeeess beepeeess Aug 20, 2014 8:40 PM Flag

    How long can it possibly take to find a partner? Is CNCE just being picky or are companies just confused with all the different types of kidney diseases out there? How many types are there? Perhaps CNCE hasn't found a way to advertise CTP-499 to all the different companies? Maybe it's hard getting the word out. Or maybe since CNCE has done most of the work, maybe companies would get a smaller percentage of the profit coming in at Phase 3 rather than Phase 1 or 2. Maybe they're having a hard time figuring out if it's worth their time & funds for a smaller percentage of the profit.

  • beepeeess by beepeeess Aug 19, 2014 4:54 PM Flag

    Here we go again. Back to a new downtrend. The stock should at least go up a decent amount before falling back down hard.

  • beepeeess beepeeess Aug 14, 2014 5:36 PM Flag

    My major purchase was at $15.75. But I also bought it in my 401k for $11.30. I don't have much in 401k though. I got screwed all the way down. I never dreamed this stock would go as low as it did.

  • Reply to

    Dammmmmmmmmnnnnnnn!!!

    by beepeeess Aug 1, 2014 4:24 PM
    beepeeess beepeeess Aug 14, 2014 5:31 PM Flag

    I own Celgene, too. What price did you buy at? I bought at $67.50 per share ($135 pre-split price).

  • Reply to

    Dammmmmmmmmnnnnnnn!!!

    by beepeeess Aug 1, 2014 4:24 PM
    beepeeess beepeeess Aug 14, 2014 2:59 PM Flag

    CTP-354 was a drug originally made by Merck & Co. But it showed substantial pharmacokinetic limitations and as a consequence, never made it past the lab. So Concert took over the drug and should be able to remove the limitations to make the drug do what it was meant to do, but perhaps even better.

  • beepeeess beepeeess Aug 14, 2014 11:09 AM Flag

    I certainly hope so :0) I don't understand how it has under-performed all other biotechs.

  • Reply to

    Dammmmmmmmmnnnnnnn!!!

    by beepeeess Aug 1, 2014 4:24 PM
    beepeeess beepeeess Aug 14, 2014 11:07 AM Flag

    It started to anyway :0) I hope it soars soon. It's got a long way to go to get to where I paid.

  • Reply to

    Dammmmmmmmmnnnnnnn!!!

    by beepeeess Aug 1, 2014 4:24 PM
    beepeeess beepeeess Aug 14, 2014 9:35 AM Flag

    This is #$%$ :0( It's tanking again

  • beepeeess beepeeess Aug 13, 2014 7:12 PM Flag

    70-80%, while anti-spasticity effects are expected at receptor occupancy levels of 30% (as seen with other
    benzodiazepines). CTP-345 is easily hitting sustained plasma concentrations sufficient for these occupancy levels in the 6mg cohort for up to 48 hours after a single dose and additionally avoiding concentrations that would cause serious sedative effects. Also, Phase II plans for CTP-345 in spinal cord injury will include a three-dose trial design with the highest dose likely to be 12mg. The company stated its goal is to improve Ashcroft scores by 25-30%. FDA trial guidance gives CNCE optionality with CPT-499 Phase III trial design
    heading into SPA discussions. During the call, the company reiterated the results from its successful FDA end-of-Phase II meeting where consideration would be given to a single multi-dose, placebo-controlled Phase III trial for approval, in contrast to initial expectations of two separate Phase III trials. Time-to-event analysis – a composite endpoint including a ≥50% increase in serum creatinine levels or progression to ESRD will likely be confirmed as the approval endpoint. This inclusion of a rapidly assessable biomarker to support the responder analysis is highly encouraging from both a time and cost perspective, in our view. The potential incorporation of higher baseline UACR levels (as a predictor of more rapid disease progression) as inclusion criteria may also shorten the time to trial readout. Significant upside potential for this deuterated drug company. We remain bullish on Concert Pharmaceuticals shares seeing several opportunities for growth over the next several years in addition to CTP-499 including: CTP-354, JZP-386, AVP-786 and CTP-730. In our opinion, the company’s DCE Platform® has all the requisite ingredients to allow CNCE to become one of the leading developers of unique, deuterated-therapeutic compounds. We reiterate our Market Outperform rating and $28 price target for CNCE shares based on our DCF and SOTP

  • Highlights Early Clinical Progress in 2Q14 Earnings Results
    MARKET OUTPERFORM | Price: $8.60 | Target Price: $28.00
    INVESTMENT HIGHLIGHTS
    Concert Pharmaceuticals detailed development plans and current Phase I results
    for CTP-354, and discussed progress for CTP-499 and partnered programs;
    reiterate Market Outperform rating and $28 price target based on DCF and SOTP
    valuation methodologies. CNCE reported 2Q14 net loss of $7.73MM, or EPS of
    ($0.45) that was higher than the JMP estimate of ($0.53), primarily on lower than
    anticipated operating expenses and higher total revenues. License revenue of $1.24MM
    was higher than our estimate of $0MM. Total operating expense of $8.96MM was
    lower than our $9.5MM estimate, comprising $6.24MM of R&D expense (lower than
    our estimate of $7.5MM) and $2.72MM of SG&A expense (higher than our estimate of
    $2MM). CNCE finished the quarter with $101MM in cash, cash equivalents and short term
    investments providing sufficient cash runway into 2016. A summary of 2Q14 actual
    results versus JMP estimates is shown in Figure 2. Incremental changes to our model
    reflecting 2Q14 results and calculated share count are summarized in Figure 3.
    Results from Phase I Multiple Ascending Dose Phase I trial of CTP-345 support
    advancement into spasticity indication. CNCE initially plans to advance CTP-354,
    a deuterated subtype selective GABAa receptor antagonist, into Phase II clinical trials
    to treat spasticity in patients with spinal cord injury. The company discussed results
    from its Phase I trial covering two multiple-dose data points of 6mg at five hours and
    6mg at 48 hours demonstrating receptor occupancy of up to 50%. We believe this
    information, coupled with the results previously reported in single-ascending Phase I
    trials, support the potential to achieve a clinical response at dosages that are below
    the threshold for adverse events. Unwanted sedative effects had previously been seen
    at doses of 20mg, reflective of receptor occupancy levels of up to

  • Roth Capital affirms Concert Pharmaceuticals (Nasdaq: CNCE) at Buy with a target price of $28 following the company's Q2 results.
    Concert reported Q2 loss of $0.45 per share versus Roth's estimated loss of $0.47 per share.
    Analyst Joseph Pantginis commented, We believe Concert is making good progress on their clinical programs, both in their in-house and partnered programs. The company's R&D expenses are expected to grow as they initiate multiple clinical studies in 2H14. CNCE expects to initiate the PhII study of CTP-354 in patients with spasticity associated with spinal cord injury later this year. We look forward to top-line data from the PhI portion of this study in October. Regarding, CTP-499, CNCE is well positioned to advance the program into PhIII, following their end of Phase II meeting with the FDA last month. The company is leaning towards a single study with two doses of CTP-499 instead of the other option raised in the meeting of conducting two parallel trials for each dose. CNCE intends on initiating discussion with the FDA regarding PhIII later this year, which will include talks of the possibility to conduct the PhIII under SPA. Regarding the partnered programs, JZP-386 PhI study was initiated last month in a first-inhuman study. The PhI study of CTP-730 is expected to initiate in the fall and AVP-786 is expected to advance into PhII in September. We believe CNCE is advancing well on the clinical front and will achieve its expectation to have up to five compounds in clinical studies by the end of the year.

  • Reply to

    can someone help?

    by jtl_bhc Aug 6, 2014 4:10 PM
    beepeeess beepeeess Aug 6, 2014 5:03 PM Flag

    What's Pulse section? I looked everywhere. I can't find anything. :0(

  • Concert Pharmaceuticals has begun a Phase I trial with CTP-354 to potentially treat spasticity and chronic pain. Previously, the compound had been Merck & Co.’s L-838417 and had demonstrated strong muscle relaxant activity and efficacy against both inflammatory and neuropathic pain. Despite L-838417’s strengths, the compound showed substantial pharmacokinetic limitations and as a consequence, never made it past the lab.The Concert Pharmaceuticals study will evaluate the safety, tolerability, and pharmacokinetics of CTP-354 in healthy volunteers. In addition, the company intends to conduct a Positron Emission Tomography study to assess brain receptor occupancy of CTP-354 in healthy volunteers. Concert expects to report top-line results of the Phase 1 single ascending dose study by the end of the year. “CTP-354 was a compound that was brought to my attention in a conversation that I was having with an expert in another field,” says Concert Pharmaceuticals CEO Roger Tung. “He had worked preclinically with the compound and had mentioned some results that he had with it as a very exciting agent. Based on that, we went back as an organization to review the available data on it, which is vast. There are a lot of publications on the underlying L-838417, which is the Merck compound. We saw this as an opportunity to apply our technology, to improve certain properties such as distribution, metabolism, and secretion to and to enable this compound to be taken into human clinical evaluation and to do what we hope it will be able to, which is be a unique ground breaking medicine.” Merck was not able to fit all of the similar properties into the compound. “What we were able to do then is to essentially start with the huge investment, the time, and the effort that they put into identifying and nearly got there and then used our technology to put us over the finish line,” Tung told R&D Pharma Business Connect. Concert’s selective incorporation of deuterium in CTP-354 significantly improved pharmacokinetic properties in preclinical models while maintaining the desirable pharmacological activity seen with the earlier generation modulators. “We see a lot of applicability to the technology to many different kinds of situations and that has led to the collaboration that we have had in a corporate sense,” says Tung. “We announced our partnership with Celgene and we think that it has the potential to have a very broad and important impact in a wide range of medicines.”

  • Reply to

    Dammmmmmmmmnnnnnnn!!!

    by beepeeess Aug 1, 2014 4:24 PM
    beepeeess beepeeess Aug 4, 2014 12:34 PM Flag

    Hellllllllllllllp!!!!!!!!!!!

  • How overvalued is this stock?

  • I think the reason they went with CTP-730 first instead of CTP-221 is because Revlimid patents are still active and have a long way to go before they expire, so there's no reason to make Revlimid better right now. If the patents expire and generic's take over, the they can use CTP-221 to make Revlimid better so patients would choose Revlimid over generics. They would actually need CTP-730 to make Otezla better right now because it can't be a blockbuster drug unless it works better. Otherwise, they might use CTP-730 for the lupus drug they're working on, but I'm not sure how I could make sense of that without knowing about competition or how effective their lupus drug is looking so far.

  • Reply to

    Coming soon: Celgene secret

    by beepeeess Jul 27, 2014 1:24 AM
    beepeeess beepeeess Jul 28, 2014 1:59 PM Flag

    CC-10004 (apremilast) is Otezla. CTP-730 could be added to Otezla to make it a much more effective drug. If considerably more effective, it could make Otezla the number one arthritis drug on the market. Which arthritis is a huge market. Otezla isn't as effective as injectable arthritis drugs, but what if it could be? If CTP-730 could make it as effective, slightly less effective, or more effective, then you've got yourself a winner.

  • Reply to

    Coming soon: Celgene secret

    by beepeeess Jul 27, 2014 1:24 AM
    beepeeess beepeeess Jul 28, 2014 1:46 PM Flag

    Most likely secret:

    ANTI-INFLAMMATORY COMPOUNDS
    Celgene is developing novel orally available small molecules that inhibit the production of multiple proinflammatory mediators including interleukin-2 (IL-2), IL-12, interferon-gamma, TNF-alpha, leukotrienes, and nitric oxide synthase.

    Celgene is developing novel orally available small molecules that inhibit the production of multiple proinflammatory mediators.
    Our lead investigational drug, CC-10004 (apremilast) is an oral compound that is being studied in multiple Phase III clinical trials for the treatment of psoriasis, psoriatic arthritis and other chronic inflammatory diseases. We successfully completed our early stage studies, demonstrating clinical activity and tolerability and meeting safety endpoints in a placebo controlled proof-of mechanism trial in moderate-to-severe psoriasis and psoriatic arthritis. With the initiation of six multi-center international clinical trials, we are advancing the clinical development of CC-10004.

    CC-11050 is currently in Phase I clinical trials for chronic inflammatory diseases.

    CC-10004 and CC-11050 are investigational products and are not approved for any indications.

AFCE
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