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Alimera Sciences, Inc. (ALIM) Message Board

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  • Reply to

    PDUFA on Sept. 26

    by hanshi_frank_dux Aug 13, 2014 10:25 AM

    There is no ADCOM -- FDA doesn't need one -- they are in labeling discussion as per the company.

  • Reply to

    PDUFA on Sept. 26

    by hanshi_frank_dux Aug 13, 2014 10:25 AM

    Keep in mind that the more significant date is likely the 22nd or 23rd when the briefing documents come out. In many cases those documents will provide good insight as to what direction the panel will head.

  • Reply to

    PDUFA on Sept. 26

    by hanshi_frank_dux Aug 13, 2014 10:25 AM

    9 trading days until PDUFA

  • Reply to

    PDUFA on Sept. 26

    by hanshi_frank_dux Aug 13, 2014 10:25 AM

    PSDV and ALIM have an 80% chance for FDA approval at PDUFA on Sept. 26.

  • Type “MicroCapReview” into your browser to learn why Millennium HealthCare (MHCC) stock price is about to explode and keep going for years. Click on “Read the latest issue and turn to page 22.

    Sentiment: Strong Buy

  • Here is the company's latest PR.

    Press Releases



    Mast Therapeutics Provides Corporate Update And Reports Second Quarter 2014 Financial Results

    - Update on Company's clinical and preclinical programs

    - 4 clinical study read-outs anticipated over the next 12 to 18 months

    - Targeting pathologies characterized by membrane dysfunction with substantial commercial opportunity

    SAN DIEGO, Aug. 11, 2014 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX) today provided a corporate update and reported financial results for the quarter ended June 30, 2014.

    Brian M. Culley, Chief Executive Officer, said: "This is an important time for Mast. We have an ongoing Phase 3 study in a rare disease with more than an 18-month head start on our nearest competitor. We have an ongoing Phase 2 study that will demonstrate whether MST-188 improves the effectiveness of a thrombolytic agent that's used everywhere from acute limb ischemia to pulmonary embolism to heart attack and stroke. We have another Phase 2 study planned in heart failure, the leading cause of hospitalization in patients over 65. And, we have cash to move these and our other programs towards major value inflection points."

    Upcoming News and Events

    ◾Phase 2 Study (pulmonary arterial hypertension): preliminary data

    Q3 2014

    ◾Phase 2 Study (heart failure): agreement with FDA on protocol

    Q4 2014

    ◾Nonclinical Study (heart failure): data

    Q1 2015

    ◾Nonclinical Study (embolic stroke): data

    Q2 2015

    ◾Phase 2 Study (heart failure): initiate enrollment

    1H 2015

    ◾Phase 2 Study (acute limb ischemia): complete enrollment

    Q4 2015

    ◾EPIC Study (sickle cell disease): complete enrollment

    Q4 2015

    ◾Phase 2 Study (WHO Group 2 pulmonary hypertension): data

    2H 2015

    ◾Phase 2 Study (heart failure):

  • Reply to

    No Confidence Whatsoever!

    by ma66walker Sep 4, 2014 11:18 PM

    Get out of this and buy MSTX. Do your own dd before you buy.

  • Definitely not a good sign when several company insiders dump shares right before a date with the FDA. Wouldn't be surprised if this dives back into the fives tomorrow.

  • ALIM has PDUFA decision on Sept. 26. 80% chance of approval. ALIM to $10 easy money for longs.

  • Reply to

    considering buying ALIM,

    by codeavenger Aug 12, 2014 12:02 AM

    I agree with your approval rate for the following two reasons. The first reason is that ALIM already has the financing for the $ 25 million in place. The second and an important one is that the manufacturing site where Iluvien is manufactured and a point of contention with the FDA has been resolved. The only question I see is the labeling for which the FDA and ALIM where attempting to resolve.

  • Reply to

    considering buying ALIM,

    by codeavenger Aug 12, 2014 12:02 AM

    Be awere of the Upcoming FDA decission on 2014.09.26. If approved perhaps $8 -10 per share and if we have a fourth rejection my guess would be $2 per share - Chances for approval 80/20. Just my own guess...

    Sentiment: Strong Buy

  • Reply to

    Good Quarter

    by paultradestoday Aug 7, 2014 10:42 PM

    Bohn, glad to see you're still around. I'm in a similar boat-I tripled my shares of psdv, but not sure if I want to hold all of them to pdufa. I sure hope we get the run up that most of us are anticipating. Good luck to you!

  • Reply to

    Good Quarter

    by paultradestoday Aug 7, 2014 10:42 PM

    No, you're not alone:-)

    I think that the turnover for Q2 and the Development in Germany was a bit disappointing and also I would have liked to hear that the launch in France were moving a bit faster. But, I am alos working in this industry and know that it is not possible to force decisions on reimbursement and pricing of the product.

    I have a lot of shares of Alimera and I believe or hope that we will see a run up in the period up to 2014/09/26... I have not yet decided if I will hold or not hold my shares during the FDA decision - I have tried this 2 times before , respectively for alimera and Psivida ....:-)

    Sentiment: Strong Buy

  • Loss (0.16) beats the street of (0.23)... (only 2 estimates) so thats good. Lots of positives about market expansion. July best month in sales. Q2 revenue $2.2 million. Big loan to consolidate debt and pay PSIVDA their $25mil when FDA approves the labeling. But it appears nobody cares. no questions; was anybody listening? I own 31500 shares and will hold until it takes off in September AFTER fda APPROVES. There is only good news and nobody cares!! Am I all alone?? Wonder what the light of day will bring? This stock doesn't really need FDA approval to be a strong profitable company. It has the rest of the world!!!!

    Sentiment: Hold

  • Revenues driven by recent contracts for the most advanced life saving diagnostics will expand 150 times in the next 24 months. And that is just the beginning!

    Millennium Healthcare (MHCC) recently announced newly SIGNED contracts with ACO’s IPA’s and MSO’s to provide exclusive, state-of-the-art, non-invasive cardiovascular and cancer diagnostics to 1,300 locations that will escalate Millennium’s current revenues of $2 million per year to over $300 million per year.

    Cardiovascular and cancer diagnostics rolling out to physician’s offices this year.

    Revenues will begin rapid growth by year end.

    Market size for Millennium Diagnostics is 35,000 primary care offices. The first 1,300 recently contracted with Millennium and the rest are standing in line to sign up with Millennium because:

    § Millenniums program increases physician’s revenues dramatically
    § Millennium’s diagnostics are fully paid by Medicare and are free to patients
    § Millennium’s diagnostics appeal to patients because they are life-saving, fast, painless and highly accurate
    § Millennium’s diagnostics are exclusive from Millennium only
    § The physician pays no up front capital costs

    Millennium’s market cap is under $40 million today and shares are selling at under $1.00.

    What will this growth do to the price of MHCC shares?

    Millennium HealthCare is well positioned for explosive growth that is rarely seen.

    Sentiment: Strong Buy

  • Reply to

    What will happen with today's news?

    by spre1975 Jun 30, 2014 8:11 AM

    afterwards, PSDV has jumped 15 percent during the last week. ALimare has dropped one percent. There should be room for some gains here .

    Sentiment: Strong Buy

  • Reply to

    What will happen with today's news?

    by spre1975 Jun 30, 2014 8:11 AM

    yep and down almost 4 percent. The trade of Alimera never stops surprising me :-(

  • who knows?! It looks good.

  • Food safety is an unsolved problem with an estimated 48 million foodborne illnesses occurring each year and costing over $50 billion.

    PURE Bioscience is revolutionizing food safety with their heavily patented “SDC” and is positioned to become a leader in the food industry.

    SDC has already been tested in several large restaurant chains and the results were significantly superior to all other methods. SDC is a powerful and extremely effective antimicrobial but it is safe to humans and has been granted the EPA’s safest product classification of a category IV.

    LARGE RESTAURANT CHAINS are placing reorders that are expected to continue to increase to very sizeable numbers. PURE believes this is a 1.5 billion dollar market and SDC is far ahead of the competition.

    Based on meetings with the USDA and the FDA, FOOD PROCESSORS are expected to be using SDC in 2015 to decontaminate produce and meat. SDC will also extend shelf life as well as reduce manufacturers costs. PURE believes this is billion-dollar market.

    No other product can do what SDC does and do it safely.

    SDC will dominate antimicrobials in hospitals, schools, homes, offices, markets, public places, cruise ships, airplanes, trains, personal products like soaps and everywhere the public gathers. Antimicrobial market for disease protection such as influenza, MRSA, etc. is another multi-billion dollar market

    SDC is perfectly safe and it continues to kill dangerous pathogens for 24 hours EVEN AFTER IT DRIES.

    PURE Bioscience is on the verge of delivering very large and fast growing revenues beginning this year and shares are trading between $1.10 and $1.20 with a very small market cap of $32 million.

    All this information can be confirmed on YAHOO FINANCE under “PURE”

    PURE is a Strong Buy and Hold

    Sentiment: Strong Buy

ALIM
5.01+0.03(+0.60%)4:00 PMEDT

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