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Alimera Sciences, Inc. (ALIM) Message Board

jdliberty02 71 posts  |  Last Activity: Aug 28, 2014 1:53 PM Member since: Jun 18, 2013
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  • Reply to

    PDUFA on Sept. 26

    by yoda_camel Aug 27, 2014 9:45 AM
    jdliberty02 jdliberty02 Aug 28, 2014 1:53 PM Flag

    I want it to be approved 110%!

    Sentiment: Strong Buy

  • Reply to

    PDUFA on Sept. 26

    by yoda_camel Aug 27, 2014 9:45 AM
    jdliberty02 jdliberty02 Aug 27, 2014 2:24 PM Flag

    I find it curious that PSDV is now trading in the neighborhood of 2x the ALIM volume, while it's sp is under the $5 institutional investor benchmark and ALIM is above. Could the PSDV volume be related to knowledge about Tethadur and not the FDA NDA decision?

    Sentiment: Strong Buy

  • Any thoughts about the spike in volume.

    Sentiment: Strong Buy

  • jdliberty02 jdliberty02 Aug 26, 2014 3:42 PM Flag

    It is my understanding that Hernando is also an ALIM shareholder, while he has argued against the upside of PSDV, he has provided valuable perspective on the history of the NDA's, CRL's, Eylea and the likelihood of an Iluvien approval. Doesn't seem like there is much more to talk about on the ALIM side other than what Tom stated about prioritizing EU vs US Iluvien development upon approval. Let's hope the FDA brings us an early approval.

    Sentiment: Strong Buy

  • jdliberty02 jdliberty02 Aug 25, 2014 10:38 AM Flag

    That is my understanding also. The facility issue was one consideration upon which the CRL was issued. The LA BoH recommendation effectively takes that GMP issue off the checklist. It would seem highly unlikely that the FDA would again raise the same facility issue if the inspection agency it utilized recommends approval of the NDA. Presumably, the substantive issue of which ALIM has been fully informed through its FDA discussions is that Iluvien be labeled to ensure its use is limited to the CDME subgroup.

    Sentiment: Strong Buy

  • jdliberty02 jdliberty02 Aug 25, 2014 1:11 AM Flag

    In the points I made in support of Iluvien approval this time around, I failed to provide a fuller context to the chronology of Hernando's position that the FDA wanted to 1st approve Eylea for DME prior to an approval of Iluvien for CDME. There have been three ALIM NDA applications. 1) the 1st in June of 2010 for DME when there were no FDA approved drugs for DME. A CRL was received by ALIM on December 26, 2010; 2) the 2nd NDA was resubmitted in May 2011 and was also for DME, but was rejected in a CRL in November of 2011, because it was not sufficiently responsive to the needs of DME patients; 3) After the October 2011 1st US CRL, ALIM pursued approval of Iluvien for CDME in the EU in early 2012 and received began receiving various EU approvals in the Fall of 2012 ; 3) Eylea was approved for Wet AMD in November 2011 and for Macular Edema following (CRVO) in September of 2012, submitted for DME in December 2013 and approved by the FDA in August 4, 2014; 4) the 3rd ALIM NDA was submitted for the CDME subgroup in April 2013 and a CRL issued in October 2013. The FDA's quick responses after the CRL to waive the Advisory Committee and enter into labeling discussions, together with the overall history of the NDA's strongly support FDA intent to approve Iluvien this time around.

    Sentiment: Strong Buy

  • jdliberty02 jdliberty02 Aug 24, 2014 7:25 PM Flag

    1. My understanding is that a Los Angeles regulatory agency inspected the facility for the FDA for GMP conformance and issued a letter to the FDA that recommended approval of the NDA.
    6. Hernando expressed the view that the FDA wanted to approve Eylea for DME before it approved Iluvien, because it wanted to prevent the off label use of Iluvien for DME rather than its limited use for CDME requested in the NDA
    7. Off label use of Iluvien for DME in the EU has not been reported.
    8. ALIM has the $25 million on hand to pay PSDV.
    9. ALIM has the necessary credit facilities and offering lined up to launch as US approval

    Hopefully Hernando's understanding is accurate that the FDA concern about Iluvien off label DME use was the primary factor that caused the FDA to issue the previous November 12, 2011 and October 18, 2013 CRL's and that Eylea's July 29, 2014 approval by the FDA and the June 30, 2014 EU/EMA recommendation of approval removed any remaining obstacles to Iluvien approval

    ALIM financial positioning to make the approval payment to PSDV and fund the US launch seem to be strong indicator that they believe approval will happen this time around. Before the previous PDUFA's did that make the same financial preparations?

    Are there any other substantive and or legitimate reasons for the FDA to not want Iluvien to be approved?

    Hernando's take on the FDA priorities makes some sense out of the FDA's iss

    Sentiment: Strong Buy

  • Reply to

    Where's The Beef ?

    by godwintom Aug 21, 2014 11:46 AM
    jdliberty02 jdliberty02 Aug 22, 2014 1:12 PM Flag

    Shares Owned as of Trans. Date
    ASHTON PAUL
    Officer Option Exercise
    Aug 1, 2014 440,741
    Only a small amount of shares have been sold. Looks like a living allowance to me. What am I missing here. There are some longs on this board who hold 50,000 to 100,000 shares or more. Ashton owns 4-8 times more, but I don't understand how our interest in seeing the share price go up diverge from hist. Ashton has approx. $2,000,000.00 plus that could be $4,000,000.00 or more given the right catalysts why wouldn't he be motivated in his own interest to do his best to make that happen?

    Sentiment: Strong Buy

  • Reply to

    Where's The Beef ?

    by godwintom Aug 21, 2014 11:46 AM
    jdliberty02 jdliberty02 Aug 21, 2014 6:11 PM Flag

    I am going to trust that with 400,000 shares or so Paul Ashton has a lot at stake, a dog in the fight as they say, and that his interests are parallel to us longs. It would be interesting to understand the decision making and the facts and circumstances related to Tethadur and the relationship to ALIM. I am a 4 year long and can't wait for the next 30 days to pass the PDUFA and approval.

    Sentiment: Strong Buy

  • jdliberty02 jdliberty02 Aug 20, 2014 11:14 AM Flag

    Mick, How do you track whether or not Kolchinsky is acquiring additional shares of PSDV at this time? I know Yahoo Finance shows Major Holders but that is as of June 30, 2014. How do you track the activity between now and then?

    Sentiment: Strong Buy

  • Reply to

    can PSDV help REGN with their Eye med????????

    by vinman2228 Aug 16, 2014 9:55 PM
    jdliberty02 jdliberty02 Aug 20, 2014 9:59 AM Flag

    If there were any truth to the idea that ALIM had an interest in acquiring PSDV wouldn't it follow that ALIMwould publicly downplay all the other valuation catalysts such as Medidur and Tethadur., and take the position that they are speculative, unproven, will cost a fortune to develop and take years to develop......

    Sentiment: Strong Buy

  • I am looking forward to this future.

    Sentiment: Strong Buy

  • jdliberty02 jdliberty02 Aug 19, 2014 5:22 PM Flag

    Thanks Hernando, I think you have given us good historical insight into the "reality" of the CRL's. No one has answered my question about disapprovals or CRL's, are they statistically always on the PDUFA date .....?

    Sentiment: Strong Buy

  • jdliberty02 jdliberty02 Aug 19, 2014 4:12 PM Flag

    Thanks for the response. Isn't the packaging issue what Hernando was talking about when he raised FDA concerns of off label use that would compete with already approved DME drugs? Isn't this the labeling discussions that ALIM indicated it was going into after the FDA withdrew the advisory committee requirement? If there hasn't been an off label encroachment in the EU wouldn't that make the labeling here in the US easier to hurdler and provide basis for replication? And last, so my understanding is correct that it is not FDA practice to deny early, but to sometimes approve early? Does anyone have any stats on this?

    Sentiment: Strong Buy

  • jdliberty02 jdliberty02 Aug 19, 2014 12:01 PM Flag

    So if the side effects have been found acceptable in the EU countries, why shouldn't they be found acceptable by the FDA? Particularly after many months of actual use. How many months has Iluvien been distributed in the EU?

    Sentiment: Strong Buy

  • Is my understanding correct, that there is a possibility for an early approval, but that the FDA as a matter of practice does not make early CRL's or denials?

    Sentiment: Strong Buy

  • jdliberty02 jdliberty02 Aug 19, 2014 10:25 AM Flag

    Hernando, is there reasonable basis to conclude that it is highly probable that Medidur will be effective without any greater side effects?

    Sentiment: Strong Buy

  • Reply to

    What if Alimera buys psivida?

    by d0319a Aug 18, 2014 7:27 PM
    jdliberty02 jdliberty02 Aug 18, 2014 8:21 PM Flag

    or 50,000 shares or $50,000.00

    Sentiment: Strong Buy

  • jdliberty02 jdliberty02 Aug 18, 2014 10:32 AM Flag

    Thanks Hernando. I just wanted to explore other value generating opportunities they may have. I appreciate the education on the amount of time for trials and approval the NDA's take. I am just thinking that irrespective of a US Iluvien approval Medidur is just another developmental asset for a major biopharm to consider in looking at a PSDV acquisition.

    Sentiment: Strong Buy

  • jdliberty02 jdliberty02 Aug 18, 2014 9:46 AM Flag

    Hernando, as Iluvien was approved in EU and is on its way to being approved in Australia and New Zealand, what is to stop PSDV from seeking EU approval for Medidur using the same Iluvien data?

    Sentiment: Strong Buy

ALIM
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