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Cempra, Inc. Message Board

imho_dyodd 45 posts  |  Last Activity: 11 hours ago Member since: Jul 19, 2012
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  • Reply to

    Jublia and Novexatin

    by imho_dyodd 12 hours ago
    imho_dyodd imho_dyodd 11 hours ago Flag

    And Mike, maybe just one follow-up. That's very helpful. Just on the Jublia launch, when do you expect you'll get the marketing materials approved? I mean, is -- given the fact that you got an approval earlier than expected?

    J. Michael Pearson - Chairman and Chief Executive Officer
    We think mid-August is about the time frame. We're going to bring our sales force in. We haven't trained them on this product. Again, they can talk through the package insert, but we're going to have a launch meeting. We're going to do it in New Jersey. It's not going to be a big fancy launch meeting, but it will be one that will bring all the sales force and train them on the materials, which we've submitted to the FDA. Once we get those materials approved, then we have to submit our advertising that we've developed, our TV ads. So we have them largely developed, but then the FDA has to review those and make sure that they're comfortable with those. So we'll get the first set of marketing materials, call it, in August, and then we'll probably get the ad approved sometime in the fall. And we're lining up TV spots and -- because we really plan to blitz the market in terms of the DTC. Because this is one that -- it's going to be largely consumer-driven because the prescribe -- if you look at like Lamisil scripts, a ton of them are in primary care because people can self-diagnose this problem. And you just look at your toes and you can tell that you have onychomycosis. So -- and the fact that the product and the label, the safety profile is so strong that when we have a TV ad, we're not going to be spending the whole time talking about the side effects. We'll be talking about the product. So we think this is a smart DTC investment, and so we think we'll both generate demand to people that maybe are taking Lamisil, generic Lamisil today, but there's huge untapped market potential here, too. People that have the condition that don't want to go oral, don't want to have a liver test. And so --

  • From Valeant's conf call:
    Given the strong reception from both physicians and patients of our recently launched products, Jublia, Ultra and Luzu, each of them has exceeded our expectations. As I mentioned, after only 3 weeks of being available, last week's script demand for Jublia exceeded over 1,300 scripts. This trend is expected to accelerate as regulatory approval for marketing materials are received and our dermatology sales force is appropriately trained. We are adding a new in-house podiatry sales force of 50 representatives. We are adding a new 80-person -- or 100-person primary care sales force through a CSO, and we are expanding our dermatology field force by at least 30 reps"

    The above highlights the market that Novexatin will enter after successful clinical trials. The market is huge.

  • dusa, pharmlucence, ranbaxy, url pharma

    taro?

  • Reply to

    fluocinonide anda approved

    by imho_dyodd Jul 20, 2014 12:41 PM
    imho_dyodd imho_dyodd Jul 20, 2014 12:59 PM Flag

    perrigo has 180 day exclusivity

  • FLUOCINONIDE
    (ANDA # 200734)
    000 FLUOCINONIDE TARO Approval 07/14/2014

  • Reply to

    could the cash be 700m now?

    by imho_dyodd Jul 19, 2014 5:13 PM
    imho_dyodd imho_dyodd Jul 19, 2014 8:13 PM Flag

    well, I have been hoping for close to 2.5 years. well, dividend is really bad from a tax perspective. i just think some top minority shareholders who have experience in evaluating phase 2 or phase 1 completed assets should join the board ..taro is still trading around 7 times ebitda if u believe june 2014 price hike would sustain.

    I just hope, wish, pray that a couple of smart minority shareholders join the board so they can steward the ship better in terms of use of cash and buying late stage specialty assets esp phase 1 completed. The board has done a fine job in pricing opportunities. But now the board has an opportunity to maximize this and take it to the next level .

  • hoping they make some deeply undervalued accretive acquisitions like ranbaxy

  • hoping taro is going to make an accretive acquisition with its huge cash. Other than Novexatin not heard of any buy from taro

  • Reply to

    rootbound - what is your view of the management?

    by imho_dyodd Jul 13, 2014 12:43 AM
    imho_dyodd imho_dyodd Jul 15, 2014 10:01 AM Flag

    Heiman - you simply cannot claim ignorance or human errors on fusilev.
    Are you telling Management(before selling stock) with likely 500 man years of pharma sales experience
    Did not know that hospitals will buy generic leucovorin when shortage ceases?
    Also the whole issue of 340b rebates should have been clearly told to investor s in the fall presentations when they were aware. It seems they were waiting to sell stock.
    Management integrity is number 1 in investing.
    I don't believe anything from this one.... apaz is just a investor bait I suspect

  • Reply to

    rootbound - what is your view of the management?

    by imho_dyodd Jul 13, 2014 12:43 AM
    imho_dyodd imho_dyodd Jul 14, 2014 1:36 AM Flag

    U must be crazy to trust this management

    Do you know how much money I lost in this scheme?

  • 1. Folotyn sales will double in a "few years"
    2. Zevalin will do $300m in a "few years" (first time said in 2010)
    3. Fusilev will grow (until Dec 2012 - coincidentally management done with selling their stock at hyped prices)
    Then 2 months later, Fusilev sales was forecast to be 40-50% lower. Forget growth,
    Management answers to analyst when asked the question. What will happen to Fusilev when generic leucovorin shortage ceases ? Fusilev sales will grow. It doesn't matter if one generic enters or two, Fusilev is pure and is shown to be safer than generic leucovorin.
    4. Hello suckers Apaz has failed p3. Don't get baited again. See the above 3 and judge for yourself

  • not bad...the Anda filing has accelerated big time. great news for long term shareholders as most of these are likely launching beyond 2016

  • We have direct presence in 9 of the top 10 emerging
    markets
    o China, Brazil, Russia, India, Mexico, Poland,
    Turkey, Saudi Arabia, and Indonesia
    o We are not directly in Venezuela, but do have
    sales there via distributors
     Over $200M in sales in 2014 for 5 of the top 6
    markets
    o China, Brazil, Russia, Mexico, and Poland
     Delivering double digit revenue growth or greater in 7
    of the 9 markets in which we have a direct presence
    o China, Brazil, Russia, Mexico, Turkey, Saudi
    Arabia, and Indonesia

  • WebMD News from HealthDay
    Finding points to possible treatment for
    By Robert Preidt

    HealthDay Reporter

    FRIDAY, June 20, 2014 (HealthDay News) -- A man with a rare condition that left him with no hair on his body grew a full head of hair after taking an arthritis drug, a new study reveals.

    The 25-year-old patient also grew eyebrows and eyelashes, along with facial, armpit and other hair after treatment with tofacitinib citrate.

    The man's lack of body hair was caused by a disease called alopecia universalis. The researchers said this is the first reported case of a successful targeted treatment for the disorder, which has no cure or long-term treatment.

    "The results are exactly what we hoped for," study senior author Dr. Brett King, an assistant professor of dermatology at Yale University School of Medicine, said in a university news release.

    "This is a huge step forward in the treatment of patients with this condition," King said. "While it's one case, we anticipated the successful treatment of this man based on our current understanding of the disease and the drug. We believe the same results will be duplicated in other patients, and we plan to try."

    The patient took 10 milligrams a day of the arthritis drug, according to the study, published online June 18 in the Journal of Investigative Dermatology.

    After two months, he began to grow scalp and facial hair, the first hair he'd grown in these areas in seven years. After three more months taking 15 milligrams a day of the drug, he had a full head of hair and clearly visible eyebrows and eyelashes, as well as facial, armpit and other hair.

    After eight months, the man had full re-growth of his body hair. He reported feeling no side effects and lab tests detected no problems.

    It's likely that the drug triggered hair re-growth by switching off the immune system attack on hair fo

  • imho_dyodd by imho_dyodd Jun 18, 2014 7:34 PM Flag

    46k...still better than last year..

  • Reply to

    Today's volume

    by valery164 Jun 12, 2014 10:58 AM
    imho_dyodd imho_dyodd Jun 12, 2014 11:56 AM Flag

    speculation aside, you are right about pick up in volume. it has materially increased. If this continues like this for 2 months, i would say taro has reached what I call FAIR LIQUIDITY or VOLUME based on peers....based on my analysis of july 2013. Remember back then the average volume 20k...DAILY FAIR VOLUME based on peers and the available public float was around 100k.

  • valean'ts product is nothing great. yet they are expecting peak $800m sales. If novexatin passes clinical trials it will cannibalize the whole market

    We acquired Jublia® through our purchase of Dow Pharmaceutical Sciences in 2008 and advanced Jublia® from pre-IND stage through Clinical Phases 1, 2 and 3," said J. Michael Pearson, chairman and chief executive officer. "We are working quickly to get this important product launched in the U.S. and Canada in the third quarter of 2014. We anticipate favorable managed care coverage in the U.S., similar to other branded antifungal agents, with peak sales of $300-$800 million in the U.S. alone and we are also working with other regulatory agencies around the world on further approvals. This is the fourth product, sourced from our acquisition of Dow Pharmaceutical Sciences, for which we have received FDA approval the other three being 1% clindamycin and 5% benzoyl peroxide gel (IDP 111), Acanya® and Retin-A Micro (tretinoin) Gel microsphere 0.08%. We have also filed a new treatment for acne, Onexton", which has a PDUFA date of November 30, 2014. All these compounds came through our Dow acquisition, bringing with it the full set of R&D capabilities from preclinical through regulatory."

  • Reply to

    interesting volume spike last 2 days

    by imho_dyodd Jun 5, 2014 7:40 AM
    imho_dyodd imho_dyodd Jun 7, 2014 1:56 AM Flag

    what is the note? can you paste the text here?

  • Reply to

    interesting volume spike last 2 days

    by imho_dyodd Jun 5, 2014 7:40 AM
    imho_dyodd imho_dyodd Jun 5, 2014 5:54 PM Flag

    take it back - clobex is generic....perrigo, fougera competitors

CEMP
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