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whippersnapper65 366 posts  |  Last Activity: Jul 2, 2015 2:33 PM Member since: Jun 20, 2009
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  • Reply to

    Neutral Post/Rant

    by mjacob56 Jun 2, 2015 5:47 PM
    whippersnapper65 whippersnapper65 Jun 2, 2015 9:04 PM Flag

    Nothing new, with the possible exception of information about next steps with the FDA regarding early approval of Rintega.

  • whippersnapper65 by whippersnapper65 Jun 2, 2015 8:51 PM Flag

    On that date Jim Cramer aired his 7:25 segment about Celldex Therapeutics. Read the following synopsis of his argument for buying CLDX, and think about how much of a better case can be made for investing in CLDX now versus then. The case for investing in CLDX has only gotten BETTER and STRONGER over two years.

    All this is to remind people and demonstrate that Celldex's revolutionary potential to succeed was apparent at least two years ago, and now we are seeing fruits of that potential begin to blossom.

    -----

    "I want to tell you about a new cancer fighting biotech name that's probably not on your radar screen," said Cramer. "The company is Celldex Therapeutics, a $13 stock with a $1 billion market cap."

    Although the stock is already up 90% since the beginning of the year, Cramer thinks the stock has more room to run.

    The reason?

    "Celldex is doing ground breaking work in one of the hottest parts of the oncology universe, what's known as cancer immunotherapy," Cramer explained. "These are drugs that use the body's natural defenses, the immune system, to target and destroy cancer cells."

    This form of therapy is expected to be a big theme going forward in cancer treatment.

    Currently conventional treatments such as chemotherapy are broad based – that is, they destroy both cancerous tissue as well as healthy tissue and come with very serious side effects.

    Celldex's technology however is different – it's targeted.

    "It's engineered to make the cells in your immune system go on a search and destroy mission, looking for specific tumors. And from the data we've seen so far, the company's approach works really well without causing harmful side effects," Cramer said.

    Specifically, a drug called CDX-011 appears to be effective in the fight against some types of breast cancer and another drug called Rindopepimut or Rindo appears to be effective in the fight against some types of brain cancer.

    If approved these two drugs could extend people's lives, significantly.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jun 2, 2015 6:15 PM Flag

    Were your price targets to be an accurate prediction of future performance, you would be correct that $50 today would be better than $57-$60 in 18-24 months.

    However, I challenge your targets. In 18-24 months I expect a share price far in excess of what you are predicting, probably in excess of $100. If my prediction is accurate, then $50 today would not be such a good deal.

    Marucci is probably by far the single largest individual private shareholder via directly held shares and vested and unvested options. He is supremely incentivized to maximize shareholder value. For him, the difference between share prices of $50 and $150 is a difference of hundreds of millions of dollars in gains.

    But beyond profit from stock gains, I believe Marucci is additionally motivated by a desire to help patients who have difficult diseases as well as a desire for prestige in heading a company that could very well revolutionize the treatment of cancer.

    Sentiment: Strong Buy

  • Reply to

    Neutral Post/Rant

    by mjacob56 Jun 2, 2015 5:47 PM
    whippersnapper65 whippersnapper65 Jun 2, 2015 5:54 PM Flag

    I suggest you listen to the webcast of Marucci's presentation at Jefferies tomorrow afternoon. That will probably go a long way toward answering many of your questions, directly from the horse's mouth. If you like what you hear, continue to hold; if you are skeptical about what you hear, reduce your position.

    Sentiment: Strong Buy

  • Reply to

    I may be way off

    by cannonblack1 Jun 2, 2015 5:40 PM
    whippersnapper65 whippersnapper65 Jun 2, 2015 5:49 PM Flag

    The abstract data have to be submitted in February. Presentation data may be more current than what the abstract contains, and that was the case with the ReACT data.

    I believe management stated that the ReACT data were current as of March.

    I doubt there will be any more current data offered tomorrow. Tomorrow's presentation will probably highlight ReACT for those who may be unaware of it, offer some insight into the next steps forward with the FDA, and include an overview of the rest of Celldex's pipeline, achievements and upcoming milestones.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jun 2, 2015 5:29 PM Flag

    That's a good one, scr.

    I can laugh at that.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jun 2, 2015 4:30 PM Flag

    Ray, I don't read anything mbb has to say, but if he thought that the post is irrelevant because its from 2013 he's sorely mistaken.

    As I'm sure you realized, the statements by Marucci and Davis expressed their vision for the company, their rationale and approach to drug development (combination therapy), and their belief that what Celldex owns is woefully undervalued and misunderstood by the market but will come to be appreciated, understood and valued eventually when the combination approach to treating cancer becomes the new paradigm.

    That interview was before the Varli combo trials were intiated, before the ReACT data were published, before the Glemba trial data were published, before the amazing preclinical proof-of-concept data for Varli were published. It offered a roadmap to the company's future, and about eighteen months later we are quite far along the road that Marucci and Davis chose, and things appear even rosier than when those statements were first made.

    I'm happy to let Marucci and Davis remain in the driver's seat. They know what they have, they know where they are going with it, they know where they are taking the company, and they have demonstrated over the past eighteen months that they can make good on their vision. All we investors have to do is wait for the company's "very, very valuable" pipeline to mature under their guidance.

    Games will be played with the share price, but that doesn't affect nor hinder the company's vision and potential one iota.

    Sentiment: Strong Buy

  • Reply to

    Rintega:

    by long_vrts2 Jun 2, 2015 1:54 AM
    whippersnapper65 whippersnapper65 Jun 2, 2015 4:20 PM Flag

    I'm not sure how the application process works for a treatment that has been given breakthrough therapy designation. Of course an NDA is required, but the ongoing nature of the conversation between the company and the FDA has a different character than the ordinary path to approval in which the phase 3 trial is completed and makes its endpoint, then a complete NDA is submitted and the FDA has a specific timeframe within which to give a response.

    With BTD, the process of completing the NDA is rolling and can be submitted in parts or stages, with frequent advisory help from the FDA. I'm positive that Celldex would not submit an NDA for Rintega based on ReACT, phase I,II and compassionate use data in newly diagnosed GBM patients, and possibly a confidential unblinding of results to date in ACT IV, unless the FDA encouraged them and assisted them in so doing. It stands to reason that the FDA would only encourage management to file an NDA for Rintega as part of BTD's procedures if the FDA were looking very, very favorably upon the prospect of approving Rintega.

    So if there is ever a mention by management prior to the end of ACT IV that it has submitted an NDA to the FDA for Rintega, at that point the fat lady will have begun to sing for the shorts. The question is whether management would announce such a development or whether the submission of an NDA under BTD procedures would be kept confidential.

    Sentiment: Strong Buy

  • Transcript from the Deutsche Bank conference on December 2, 2013. What Marucci and Davis stated still holds true; in fact, we are beginning to glimpse their vision becoming reality. Longs, keep your sights set on the future, for what Celldex owns is "very, very valuable" in Davis' words.

    Alethia Young
    What accomplishment are you guys most proud of this year in your story?

    Anthony S. Marucci
    We continue to grow. The data readouts have been positive and we just continue to build the Company to where we want to get to in the future. So I mean obviously the stock price is great but our job is to develop the Company and the drugs and that's what's most important to us.

    Alethia Young
    And then also just what do you believe is kind of not well understood, it's a pretty controversial stuff, so what would you express over the next two minutes or so that you wish were more understood?

    Anthony S. Marucci
    It is a complicated story. We don't have just one technology, we don't have just one way of doing things. I think we're looking at a broader application of immunotherapy and what we have built on during our early years in this business. So I think that's what people need to understand a little bit more. We are not one technology, we are not one platform, we are developing drugs that we believe are important in the cancer field, whether they will be using ADCs, vaccines or the traditional antibodies. The one thing that I think people need to understand is that we really believe down the road that the future is going to be combination of therapies, and so we believe that we have the assets in place both internally and access on the outside to make that happen. Tom?

    Thomas Davis
    I think we have a pipeline that would be very respectable in a much, much larger company and I don't think people really recognize that there are multiple opportunities here, both alone and in combination, and that what we hold is very, very valuable from a pharmaceutical perspective.

    Sentiment: Strong Buy

  • Reply to

    Just another day

    by dorriswelch Jun 2, 2015 2:29 PM
    whippersnapper65 whippersnapper65 Jun 2, 2015 3:30 PM Flag

    Ignore him; that's how you tolerate him. Make him dead to you, as he is to me.

  • Reply to

    UH OH....Look out below!!!!

    by dorriswelch Jun 2, 2015 9:40 AM
    whippersnapper65 whippersnapper65 Jun 2, 2015 10:01 AM Flag

    And there's mbb with his automatic red thumb down for my post. I don't read him and it bothers him, but I notice that every time his greyed out messages appear on the board my posts get red thumbs. What an inferior loser.

  • Reply to

    UH OH....Look out below!!!!

    by dorriswelch Jun 2, 2015 9:40 AM
    whippersnapper65 whippersnapper65 Jun 2, 2015 9:57 AM Flag

    But you can swat him: ignore him. Dorris, mbb, rule, nick are all on my ignore list and they don't bother me one bit. Swat all of them and be done with them.

  • whippersnapper65 whippersnapper65 Jun 1, 2015 10:08 PM Flag

    Well said, mymandon!

    Sentiment: Strong Buy

  • Reply to

    General Question

    by vpg1720 Jun 1, 2015 7:11 PM
    whippersnapper65 whippersnapper65 Jun 1, 2015 7:31 PM Flag

    The Jefferies conference will provide a forum for discussing Glemba, Varli and other drugs in the deep pipeline.

  • 1. Trial met endpoint
    2. Statistically significant overall survival -- the gold standard in oncology
    3. Every clinical measure favored Rintega
    4. Numerous durable survivors, some without disease progression as yet
    5. The foremost GBM doctor in the U.S. endorsed FDA early approval
    6. Management showed similarity of Rintega's data to the data that garnered FDA approval for ipilimumab
    7. Analysts began to state that commercialization of Rintega is now expected and raised their price targets

    All of THAT, and CLDX's share price closed DOWN today?

    Who would have seriously suggested prior to today that with all of those positive events dovetailing CLDX would not experience a huge rally? Nobody in his right mind.

    CLDX should have closed up at least 25% on all the aggregate positive developments that occurred yesterday and today.

    That all raises the question: what the heck is going on?

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jun 1, 2015 3:03 PM Flag

    Yes, that is exactly what it is.

    Sentiment: Strong Buy

  • Seems that more often than not the market fails to give CLDX its due.

    Sentiment: Strong Buy

  • aggravating

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jun 1, 2015 8:00 AM Flag

    I have never seen a post from elvis until today, and I"ve already put him on ignore because his intentions are duplicitous.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 May 31, 2015 9:25 PM Flag

    If the FDA is going to wait until the phase 3 ACT IV trial is complete before approving Rintega at all, then there was no point in awarding it breakthrough therapy designation. BTD indicates the FDA is inclined to favor approving Rintega early, as long as trial data support the decision. Well, trial data support that decision. Full early approval for relapsed patients should be had within two months; what the FDA will decide about newly diagnosed patients -- whether to grant conditional approval pending the outcome of ACT IV or whether to hold off on approval for newly diagnosed patients altogether until the end of ACT IV -- is the big question.

    I believe management, doctors and advocates will make a case to the FDA for full approval of Rintega in relapsed patients and conditional approval in newly diagnosed patients pending confirmation of efficacy at the end of the ACT IV study. I also believe the FDA will go along with that.

    Sentiment: Strong Buy

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