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Celsion Corp. Message Board

flogonuzim 115 posts  |  Last Activity: Mar 28, 2015 8:47 AM Member since: Jan 21, 2010
  • 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

  • great news. Wonder why?

    buy more celldex

    Sentiment: Strong Buy

  • Reply to

    I think CLDX will run from here.

    by weightbayou Feb 18, 2015 3:15 PM
    flogonuzim flogonuzim Feb 18, 2015 3:32 PM Flag

    Couldn't agree more weightbayou. Undervalued, controlled by institutions. When tutes are ready.....we will fly high.

    Sentiment: Strong Buy

  • Reply to

    Volume in last 3 trading days too low

    by aqnguyen Feb 17, 2015 3:56 PM
    flogonuzim flogonuzim Feb 17, 2015 4:42 PM Flag

    Tutes are in control. They have hedged their bets with some short positions. When they cover, the move north will be monumental. Low volume will most likely continue. Not many shares available unless Tutes move them.

    Sentiment: Strong Buy

  • I stopped and asked him if he had his son in training. He said yes.....they and wanted to do something to help people.

    I didn't care what color he was or what political party he belonged to. I also didn't stereotype them as red necks.

    The bigotry on this board is absurd.

    Buy more CLDX

    Sentiment: Strong Buy

  • flogonuzim flogonuzim Feb 17, 2015 11:18 AM Flag

    good ole last offering pricing........will be a nice trigger!

    Sentiment: Strong Buy

  • Reply to

    ASCO may 29th to june 2nd .

    by obnox2 Feb 15, 2015 4:20 PM
    flogonuzim flogonuzim Feb 15, 2015 4:33 PM Flag

    uh.....that would be 3 1/2 months after Leerink.

    Sentiment: Strong Buy

  • Reply to

    Final Rindo readout to be presented at ASCO

    by flogonuzim Feb 14, 2015 4:59 PM
    flogonuzim flogonuzim Feb 15, 2015 8:06 AM Flag

    mymandon, starting at minute 9 mark to about 9:20 of webcast he says "near final or final data at ASCO." So....it will be one or the other and it will put them in a better situation to work with FDA.

    Also, some interesting discussion on Viii from 10:35 mark to 12:30.

    Finally, their discussion on commercialization and action taken......they are very confident this will go to FDA for accelerated approval.

    Sentiment: Strong Buy

  • During the webcast they said the Rindo final readout would be presented at ASCO.

    Anyone think they would present at ASCO if the results were not stellar?

    See you at $35

    flog

    Sentiment: Strong Buy

  • Rindo will be huge. Varli will make Rindo look small. Hold on to your shares.

    Sentiment: Strong Buy

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