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Celsion Corp. Message Board

flogonuzim 133 posts  |  Last Activity: Mar 3, 2015 9:02 AM Member since: Jan 21, 2010
  • Reply to

    AF gives bullish dialogue on Celldex

    by flogonuzim Feb 27, 2015 6:40 AM
    flogonuzim flogonuzim Mar 3, 2015 9:02 AM Flag

    did not buy it. It went up pretty fast so I concluded it was about done. Thanks mmb

  • Reply to

    CDX-301 related abstract out

    by gerald_pontificus Mar 1, 2015 12:48 PM
    flogonuzim flogonuzim Mar 2, 2015 3:25 PM Flag

    yw gp!

  • Reply to

    CDX-301 related abstract out

    by gerald_pontificus Mar 1, 2015 12:48 PM
    flogonuzim flogonuzim Mar 2, 2015 2:40 PM Flag

    Circulating precursors of human CD1c+ and CD141+ dendritic cells.

    Authors
    Breton G1, Lee J2, Zhou YJ2, Schreiber JJ3, Keler T4, Puhr S2, Anandasabapathy N5, Schlesinger S1, Caskey M1, Liu K6, Nussenzweig MC7.
    Author information
    Journal
    J Exp Med. 2015 Feb 16. pii: jem.20141441. [Epub ahead of print]

    Affiliation
    Abstract
    Two subsets of conventional dendritic cells (cDCs) with distinct cell surface markers and functions exist in mouse and human. The two subsets of cDCs are specialized antigen-presenting cells that initiate T cell immunity and tolerance. In the mouse, a migratory cDC precursor (pre-CDC) originates from defined progenitors in the bone marrow (BM). Small numbers of short-lived pre-CDCs travel through the blood and replace cDCs in the peripheral organs, maintaining homeostasis of the highly dynamic cDC pool. However, the identity and distribution of the immediate precursor to human cDCs has not been defined. Using a tissue culture system that supports the development of human DCs, we identify a migratory precursor (hpre-CDC) that exists in human cord blood, BM, blood, and peripheral lymphoid organs. hpre-CDCs differ from premonocytes that are restricted to the BM. In contrast to earlier progenitors with greater developmental potential, the hpre-CDC is restricted to producing CD1c(+) and CD141(+) Clec9a(+) cDCs. Studies in human volunteers demonstrate that hpre-CDCs are a dynamic population that increases in response to levels of circulating Flt3L.

    Sentiment: Strong Buy

  • flogonuzim flogonuzim Feb 27, 2015 5:50 PM Flag

    poor dorris didn't see that touch and go landing today.

    Sentiment: Strong Buy

  • Reply to

    I bet the over allotment shares are purchased.

    by flogonuzim Feb 27, 2015 1:18 PM
    flogonuzim flogonuzim Feb 27, 2015 1:51 PM Flag

    I promise....I do not have a crystal ball or ESP.

    Sentiment: Strong Buy

  • The IO's would be crazy NOT to buy them up at that price.

    Sentiment: Strong Buy

  • Reply to

    Short interest down about 5.5%

    by flogonuzim Feb 27, 2015 6:35 AM
    flogonuzim flogonuzim Feb 27, 2015 8:24 AM Flag

    sorry about that.....guess i missed it!

    Sentiment: Strong Buy

  • Reply to

    Short interest down about 5.5%

    by flogonuzim Feb 27, 2015 6:35 AM
    flogonuzim flogonuzim Feb 27, 2015 7:41 AM Flag

    lol...........I get a thumbs down for posting short interest being down. hillarious!

    Sentiment: Strong Buy

  • Reply to

    AF gives bullish dialogue on Celldex

    by flogonuzim Feb 27, 2015 6:40 AM
    flogonuzim flogonuzim Feb 27, 2015 7:40 AM Flag

    frank.....I gave one of my son's a tip to get into MNKD and he didn't do it. He's kicking himself right now. I also believe MNKD will rise to the occasion! Yes......AF has yanked my chain a few times but his track record isn't too bad.

    Sentiment: Strong Buy

  • Burt R. asks, "Can you talk about the impact of Breakthrough Therapy Designation on Celldex Therapeutics? I understand this is good news but less sure if it increases the chances for getting the [brain tumor] drug approved."

    For those who missed the news from earlier this week, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to Celldex's rindopepimut for the treatment of patients with EGVRvIII-positive glioblastoma, an aggressive form of brain cancer. Celldex also tagged rindopepimut with the brand name Rintega.

    The simple answer to your question is yes, Rintega's odds for FDA approval are improved with breakthrough designation. What I like best about the news is that Celldex filed for breakthrough designation after a meeting with FDA to share the positive, interim results from the Rintega "ReAct" phase II study in recurrent glioblastoma patients. The FDA's affirmative decision on the breakthrough request suggests regulators were encouraged by the ReAct data and will be more amenable to accept and review Rintega for accelerated approval.
    A lot of things need to go right first, but you can put together a plausible scenario under which Rintega is approved in the middle of next year. That's potentially huge for Celldex.

    I wrote about the positive, interim results from the ReAct study last November when the data were presented. Rintega plus Avastin significantly delayed tumor progression and prolonged overall survival compared to Avastin alone. The patients enrolled in the study has recurrence of EGVRvIII-positive glioblastoma but had not yet been treated with Avastin.

    Celldex designed the ReACT study to be exploratory, meaning it wasn't intended to be strong enough to support a Rintega regulatory filing. But as recounted on its conference call Tuesday, Celldex met with FDA to share the interim Rintega ReAct data and begin discussions on the possibility of using the study as the basis for a regulatory filing.

    Celldex's Chief Medical Officer Tom Davis:

    First, we have been in initial and formal discussions with the FDA, which led to our decision to apply for Breakthrough designation. We believe the FDA's decision to grant this designation underscores Rintega's therapeutic potential for patients with glioblastoma and speaks to the potential clinical relevance of this particular subset. We have been very candid about the fact that bevacizumab [Avastin] naïve group within ReACT was not designed to be an approval study, but given the dearth of treatment options for patients facing this disease and a statistically significant survival benefit the study demonstrated at the interim, with the urging of our investigators, we feel that we have an obligation to patients to formally discuss the final data set with the regulators assuming that it remains consistent.

    Final results from the Rintega ReAct study will be ready for presentation in June at the annual meeting of the American Society of Clinical Oncology (ASCO). If the interim results hold up, Celldex will go back to FDA and seek permission to submit Rintega for accelerated approval in recurrent glioblastoma, supported by the ReAct study results.

    If FDA says yes (and the granting of breakthrough status suggests the agency is already leaning in that direction), Celldex could probably complete an FDA submission in early 2016. Historically, FDA reviews breakthrough status drugs with alacrity, which means Rintega could be approved in the middle of 2016. If you want to be more conservative, maybe approval happens in the third quarter. Regardless, Rintega makes it to the market much faster than most people ever expected.

    The ongoing phase III "ActIV" study of Rintega in newly diagnosed glioblastoma patients (enrollment complete) could serve as the required confirmatory study to backstop the accelerated approval.

    Celldex executives couldn't speak with me this week to confirm (or throw cold water) on my bullish Rintega scenario because they were on lockdown finalizing a follow-on public offering of 7.25 million shares at $24 per share. The sale nets the company $164 million, which could balloon to more than $200 million if the over-allotment is sold.

    At the risk of sounding too optimistic (and so unlike my normally skeptical self), Celldex had a great week with breakthrough and the successful stock offering. The middle of the year will be super busy with the final ReAct data, a go/no-go interim analysis from the Act IV study and the FDA meeting on an early Rintega filing. There's a lot to like about Celldex and I didn't even mention the rest of the company's cancer immunotherapy pipeline. I'm loathe to praise a New York Giants fan (and a Patriots hater), but Celldex CEO Anthony Marucci is on a roll.

    Sentiment: Strong Buy

  • Was 22,484,282 and is now 21,275,300. Up 20 cents premarket.

    Sentiment: Strong Buy

  • Lots of information in it if you are interested in what the company is doing. The opportunity of a lifetime.

    Sentiment: Strong Buy

  • Make no mistake folks......they are gearing up to take Rintega to market via Accelerated Approval process. They will have absolutely NO funding concerns along the way. This latest offering will make sure Rintega gets every bit of attention and work it needs to get to market while keeping all other programs moving as planned. CLDX will eventually be added to the BP list. Instead of who will buy CLDX out.....it will be who will CLDX buy next.

    Sentiment: Strong Buy

  • flogonuzim flogonuzim Feb 24, 2015 6:34 AM Flag

    Thanks LV.....I posted this on twitter giving you the kudos.

    Sentiment: Strong Buy

  • Insanity. Cover......Institutions have the majority of the short position to hedge their bets for the 92+% of the shares they own. Dude......when they cover, you will be left in the friggin' dust. Cover now, go long. Don't lose the farm over this.

    Sentiment: Strong Buy

  • flogonuzim flogonuzim Feb 20, 2015 12:39 PM Flag

    yes whippersnapper.....proof of revising the trial protocol has increased enrollment rate would be very good. An interim peek with obvious good results for Glemba would set the sails northward bound.

    Sentiment: Strong Buy

  • That could stir up a bit of a squeeze. Interim peek due on that study?

    Sentiment: Strong Buy

  • Reply to

    Bush repeatedly said.....

    by cyoung8404 Feb 19, 2015 11:14 AM
    flogonuzim flogonuzim Feb 19, 2015 11:31 AM Flag

    because they are terrorist that just happen to be Muslims?

  • Reply to

    Yahoo MB is messed up

    by grey3840 Feb 19, 2015 10:55 AM
    flogonuzim flogonuzim Feb 19, 2015 11:01 AM Flag

    and again......and again.....and again

  • It will fly by.

    Buy More Celldex

    Sentiment: Strong Buy

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