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Celldex Therapeutics, Inc. Message Board

whippersnapper65 219 posts  |  Last Activity: 20 minutes ago Member since: Jun 20, 2009
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  • Read it and weep over the weekend, shorts: Celldex is preparing for regulatory submissions.

    Manager/Sr. Manager, Regulatory Affairs CMC & Operations (Needham, MA)

    Overview:

    Celldex is looking for a candidate to manage regulatory CMC aspects of Celldex's therapeutic development programs, in collaboration with regulatory product leaders. Responsibility includes authoring and reviewing CMC sections in regulatory submissions. This person will also manage regulatory submissions and applications for clinical trials, agency meetings, annual reports, and maintenance required for INDs and CTAs.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Mar 20, 2015 1:39 PM Flag

    Translation: The United Federation of Planets (CLDX) has a super-weapon in development and testing. You would be well advised to make an alliance with it now. Once this super-weapon has been proven in tests, everyone -- EVERYONE -- will want to own it.

    Sentiment: Strong Buy

  • whippersnapper65 by whippersnapper65 Jan 22, 2015 7:14 PM Flag

    Celldex is growing and expanding, and new positions continue to be added. Management must be confident that there will be ample revenue to justify the additional personnel and operational costs associated with ramping up (commercial) production and increasing clinical investigations of treatments deep in the pipeline.

    Management is conducting business as if early approval of Rindo is a fait accompli.

    Sentiment: Strong Buy

  • Glemba is not only viable, it's FDA and EU accelerated-approvable.

    Varli is not only viable, major pharmaceutical companies are lining up and providing their own drugs to see how much Varli improves their efficacy.

    Shorts have three huge reasons to be worried about their increasingly losing short positions in CLDX.

    Sentiment: Strong Buy

  • Reply to

    Hillary Clinton Disgusts Me

    by j20tower Mar 10, 2015 3:16 PM
    whippersnapper65 whippersnapper65 Mar 10, 2015 3:54 PM Flag

    Someone as unscrupulous as she should not be given any U.S. government responsibility, certainly not elected president. None of her crimes and indiscretions matter to liberals, however. Liberals are all corrupt; if they weren't, they wouldn't be liberals.

    Sentiment: Strong Buy

  • whippersnapper65 by whippersnapper65 Jan 28, 2015 3:48 PM Flag

    A new one today is: Director, Biopharmaceutical Process Development (Hampton, NJ or Needham, MA). Note how the job description mentions being responsible for "process scale up/optimization... for late state clinical development and subsequent commercialization of new biopharmaceutical products." Celldex is ramping up for commercialization.

    Job Description:

    This position will be responsible for managing drug substance and sterile drug product contract manufacturing operations, including tech transfer, process scale up/optimization, and process validation for late stage clinical development and subsequent commercialization of new biopharmaceutical products. This role requires a strong scientific background, strong project management skills, experience working with/for contract manufacturing organizations (CMOs), and demonstrated ability to develop biopharmaceuticals for clinical and commercial use. Strong interpersonal and communication skills are required.

    Sentiment: Strong Buy

  • Reply to

    Institutional Ownership 85.41%

    by thegreyfog Mar 1, 2015 7:48 AM
    whippersnapper65 whippersnapper65 Mar 1, 2015 8:41 AM Flag

    If you notice on the NASDAQ site, the number of outstanding shares has increased to 97 million abruptly.

    It is clear that the abrupt change in the IO and in the total shares is a direct result of the secondary offering. Those shares are now in circulation, increasing the total shares outstanding. There is no official record of institutions having purchased those new shares, and until such a record is filed with the SEC NASDAQ cannot assume that the shares are in institutional hands; thus the new shares are not counted among institutional ownership, which accounts for the drop from 92% to 85%.

    I believe those new shares have been purchased by institutions, not by retail, and when the SEC filings show updated institutional ownership the IO percentage will be close to 95%.

    Not to worry. Institutions are increasing their holdings of CLDX. The data you noticed is a result of making a new calculation on the basis of incomplete information.

    Sentiment: Strong Buy

  • The corporate and scientific journal news during the 1Q of 2015 has been the best it has ever been for Celldex, yet the share price appreciation still lags fair value. 2Q ought to have its own slew of positive news for the company, leading to new all-time highs for the stock. I have noticed that new aliases bashing CLDX have been appearing and posting more frequently. Forces are at work to bash the stock in an attempt to counteract the excellent news that is shared and discussed on this board. For shorts it will be a losing endgame: the success of CLDX is building and obvious for all who have eyes to see and ears to hear and will steamroll over them all.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Mar 21, 2015 11:38 AM Flag

    I don't think that Glemba will need breakthrough designation because it's already in an accelerated approval trial. As long as the current phase 2 trial meets the already-specified endpoint, the FDA and the EU have assured management that accelerated approval will be granted to Glemba. I believe a phase 3 trial would have to be conducted in order to make the accelerated approval an unconditional full approval, but Glemba would already be on the market at that point, at least for the subset of TN GPNMB+ breast cancer patients. Under such circumstances, I don't know what advantage there would be in receiving breakthrough designation for Glemba. It's already a highly favorable set of regulatory circumstances.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Mar 21, 2015 11:20 AM Flag

    "Bubbly" is often a sourpuss's term used in reference to a stock that is approaching fair valuation that he wasn't intelligent or courageous enough to purchase when it was undervalued or when the company's technology or future impact on the market wasn't well known. Just because the market is waking up to what fair valuations ought to be doesn't make the new valuations overvalued.

    Sentiment: Strong Buy

  • Not just fried -- nuked.

    That announcement could be made ANY DAY between now and July or so. Think about it: the first interim look at 50% of events (meaning deaths) hasn't been delayed this long because patients are dying; it's because they are living. Why would they be living? Oh, maybe because Rindopepimut is working?

    Combine that with the FACT from the ReACT data that patients treated with Rindopepimut survived longer than control patients and even longer than expected by anyone familiar with GBM, and you have a reasonable probability that the Rindo patients in ACT-IV are living so much longer than the control patients that the trial will demonstrate statistical significance at the first interim look.

    It would be unethical to deny control patients Rindo after it has been proven to work.

    Shorts, you not playing with fire, you are playing with nuclear weapons.

    Sentiment: Strong Buy

  • No Democrat is willing to implement the strategy outlined below. That is why, especially in these times, no Democrat should be entrusted with governance.

    Retired Lt. Col. and Fox News Strategic Analyst Ralph Peters said that the US must avoid nation building and overlitigating the war on terror and instead “leave behind smoking ruins and crying widows” on Friday’s “O’Reilly Factor” on the Fox News Channel.

    Peters said the plan for fighting war is “one, you accept that you are in a war. Two, you name the enemy: Islamist terrorists. Three, you get the lawyers off the battlefield and out of the targeting cell. You accept there will be collateral damage, and do you not apologize for it, you do not nation build. You don’t hold — try to hold ground. You go wherever in the world the terrorists are and you kill them. You do your best to exterminate them, and then you leave, and you leave behind smoking ruins and crying widows. If in five or ten years they reconstitute and you have got to go back, you go back and you do the same thing and you never never never send American troops into a war you don’t mean to win.” And “be as merciless as the enemy, if you’re not willing to do that, they will win.”

  • Reply to

    *** GIANTE RED CANDEL ALEART FOR MON CLDX ***

    by mabiotech Jan 4, 2015 2:43 PM
    whippersnapper65 whippersnapper65 Jan 4, 2015 3:23 PM Flag

    Some of us think mabio is an ironic long. He seems to be a parody of short bashers. Usually his appearance portends a major upward move.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 26, 2015 2:53 AM Flag

    If Varli (1127) proves effective in phase 2 clinical trials then CLDX ought to trade at ten times the current valuation.

    When the market realizes that then the share price will be close to $80.

    Sentiment: Strong Buy

  • Reply to

    Neuro-Oncology Ads

    by fludyspnea Feb 19, 2015 12:23 AM
    whippersnapper65 whippersnapper65 Feb 19, 2015 7:15 AM Flag

    Think of it this way: why call attention to yourself in such a high profile manner unless management has no doubt whatsoever that early approval is in the bag.

    The FDA might have communicated that as long as the final ReACT data set is as positive as the near-final interim results that were presented in November then early approval would be granted. With an assurance such as that, and with the final data probably already in hand or within no more than two more months of being in hand, management must know that Rindo will be granted early approval.

    Management is not so inept as to expose itself so publicly to humiliation regarding its inaugural product.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 27, 2015 7:14 PM Flag

    I was a MEDX shareholder at the time of the buyout orchestrated by Howard Pien. Although I made a handsome return on that investment, I believe the company was sold too soon and for too little: shareholders could have gained five times as much as they received from the buyout had Medarex remained independent through FDA approval of Ipilimumab.

    I hope Celldex's management doesn't make the same error that Howard Pien made by selling the company too soon and for too little. Although Celldex was a spinoff of Medarex, the progeny has grown to be bigger than the parent: Celldex's assets are far more valuable than anything Medarex had.

    If there hasn't been a buyout already, it seems that Marucci intends to keep Celldex independent at least through FDA approval of Rindo. Waiting for FDA approval of Glemba and phase-2 results from Varli before making any buyout deal would probably maximize value for shareholders.

    Sentiment: Strong Buy

  • Reply to

    Dilution at this time was smart

    by zanghia Mar 1, 2015 2:03 PM
    whippersnapper65 whippersnapper65 Mar 1, 2015 2:38 PM Flag

    You misunderstand: the recent raising of money via a secondary offering wasn't to fund a trial; it was to raise sufficient capital to bring Rintega to market after early approval without jeopardizing any of the other programs in development that Celldex is already funding. The company had adequate cash reserves to fund operation through 2016, but the CEO added something new during Tuesday morning's conference call: if the FDA were to grant early approval to Rintega, the company would need more money to cover the additional expenses required to bring it to market. Lo and behold, that same afternoon Celldex announced it was raising an additional $175-$200 million dollars. That was not a coincidence; that was a perfectly planned and executed series of events to communicate to investors that Rintega will be granted early approval.

    Sentiment: Strong Buy

  • Reply to

    Richard A. van den Broek

    by gerald_pontificus Mar 24, 2015 3:04 PM
    whippersnapper65 whippersnapper65 Mar 24, 2015 3:11 PM Flag

    Just another one of the bread crumbs that intelligent investors are following to the pot of gold at the end of the CLDX trail. Every single piece of information points to an emerging blockbuster biotech company called "Celldex". The only intelligent investment decision is to go long CLDX.

    Sentiment: Strong Buy

  • Yahoo won't let me post the url nor excerpts from the article. It is titled "The Coming Wave of New Cancer Fighting Drugs" by Caroline Chen.

    Go there to read it.

    Celldex is a solid company and the share price should benefit by being in an emerging hot subsector in biotechnology. When Rintega is approved early by the FDA as the second cancer vaccine approved for use in the USA, it will add to the narrative mentioned in the article as well as catapult Celldex into the limelight as being at the vanguard of immuno-oncology.

    Sentiment: Strong Buy

  • Reply to

    Once Again This President Refuses

    by j20tower Jan 7, 2015 1:16 PM
    whippersnapper65 whippersnapper65 Jan 7, 2015 1:25 PM Flag

    Islam is of the devil. It is a severe threat to Western civilization. Those who advocate tolerance do not understand Islam. The so-called "extremists" are actually the faithful Muslims. The so-called "moderates" are merely not practicing their religion faithfully.

CLDX
27.84+0.67(+2.47%)Mar 30 4:00 PMEDT