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Celldex Therapeutics, Inc. Message Board

whippersnapper65 360 posts  |  Last Activity: 2 hours 57 minutes ago Member since: Jun 20, 2009
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  • Rintega has been given breakthrough therapy designation, which entails that regulatory meetings regarding its approval and the application for approval occur on a rolling basis. There are no hard deadlines, no single advisory committee meeting scheduled well ahead of time, no material information about the regulatory pathway that Celldex management can share with investors.

    Early approval for Rintega would be a sudden, surprise announcement; no advance warning about a binary event will be given. It would come like a thief in the night. Management would simply issue a P.R. some morning or afternoon stating the fact of early approval.

    And it could occur anytime. Celldex has the updated ReACT data in hand. We don't know when it will be given to the FDA, and we don't know when the FDA will act.

    What we do know is that Celldex is proceeding full-speed ahead as if Rintega's approval is a foregone conclusion.

    You will either have shares or not when the announcement is made. After the announcement, shares will be much more valuable.

    Sentiment: Strong Buy

  • The PR on the company website has a link to the poster that was displayed at the conference.

    Pay special attention to the Kaplan Meier curves that show Varli and anti PD-1 treatments working synergistically as being superior to anything else separately.

    If that doesn't astound you and make you eager to see clinical results, I don't know what else to tell you.
    If it doesn't make you want to buy more shares, you need some help.
    If it doesn't make you want to close your short position, you are beyond hope and help.

    If it isn't making BMS and Roche salivate over Celldex's pipeline, their management teams aren't paying attention.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 May 21, 2015 2:29 PM Flag

    Great news. There seems to be no valid reason why Rintega should not be approved for use in relapsed and frontline treatment immediately.

    Sentiment: Strong Buy

  • Monday's trading produced a doji with a long wick upward. Tuesday's trading produced a doji with a long wick downward. The price is essentially unchanged from Friday's close, and it has traded within a fairly wide $2 range over the past two days.

    That indicates indecision on the part of traders. Shorts don't have the confidence to keep selling, nor have buyers had the confidence to commit to large holds.

    The chart is extremely bullish, with the handle now extending and holding nicely out past the lip of the cup at $32.

    The indecision over the past two days could be a precursor to a major upward move, as buyers await confirmation of bullish sentiment. I expect there to be a $3-$4 single-day rally soon as the indecision dissipates and buyers clamor into the stock when the bullish cup and handle has been sufficiently confirmed. That will set the stage for a significant rally into the high $30s to test the all-time high at $38.84.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jun 13, 2015 6:17 PM Flag

    If people can pretend that they are a different sex and everyone has to be coerced into going along with that idiocy, why shouldn't people be permitted to pretend they are a different race?

    Our society is witnessing the logical consequences of the incoherence of liberalism. If how people feel is the way reality is determined -- as in the reality of marriage being determined by who people love (regardless of their sex) or the reality of sex/gender being determined by how people self-identify (regardless of their chromosomes or genitals) -- then why can't someone who is white feel that she is black and self-identify as black (regardless of skin color or genes or ethnic heritage)? Liberals have no coherent argument against that white woman who is pretending to be black. None. To argue against her would require establishing an objective measurement for reality instead of a subjective measurement, and once you do that you have turned away from liberalism toward conservatism.

    If you hold that Dolezal is lying about being black, then you must also hold that Bruce is lying about being a woman and that SSM participants are lying about being married. Of course, they are all lying -- lying to themselves and lying to society -- and the gullible, the stupid, the weak are buying into the lies while the cultural elite leftists are using the lies to advance their transformation of society.

    The emperor has no clothes! Can't you see what idiocy leftist/liberal philosophy entails? The emperor has no clothes!

  • Reply to

    So Obama Uses The N Word

    by j20tower Jun 22, 2015 10:40 AM
    whippersnapper65 whippersnapper65 Jun 22, 2015 11:13 AM Flag

    Obama has shown time and time again that he has no class. The TV humor shows he appears on, the kinds of events he hosts at the White House, interjecting himself into tense local events in order to stoke racial division, taking a selfie at Mandela's funeral. Obama wants to be the cool guy; the problem is that coolness is not the decorum required of the president nor a world leader. Obama attracts supporters who have little idea what responsible adulthood and responsible governing entail.

  • ASCO abstract titles and program information about sessions and speakers will be available on Monday.

    Management has stated that it expects to present final ReACT data at ASCO. I'm eager to know what the presentation forum will be. I'm also eager to know what other treatments in Celldex's pipeline will have a presence at ASCO.

    If ReACT is going to be featured prominently, there ought to be a company PR issued early next week stating so.

    Shorts, you'd better cover. April options expire at the end of this week. If those are suppressing the share price now, they won't be doing so on Monday, a day on which your short position could blow up in your hands. The chart is signaling a high likelihood of an imminent bullish breakout. Good news about ASCO would accelerate and intensify the rally.

    Sentiment: Strong Buy

  • June 1 will be the first trading day following the oral session about ReACT data at ASCO. The data should be so good as to immediately cause the share price to surpass $40 on expectation for early approval of Rintega.

    That date, June 1, will mark the beginning of a new era for CLDX: the phase-in of commercialization in a way that the market can no longer deny CLDX's potential. It will mark the beginning of a massive bull run for the stock extending over subsequent years as Glemba and Varli both move forward in the lineup toward commercialization as well and the potential of Celldex's combination immunotherapy pipeline finally becomes known and better understood and valued.

    People have only one month left to buy shares of CLDX before those who don't already own shares will look back at today's share price in disbelief and say to themselves, "If I had only known back then or only had the courage to buy, I could have owned CLDX when it was so cheap!"

    Sentiment: Strong Buy

  • 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 17, 2015 2:50 PM Flag

    Every day good news. However, this news is of the sort that, unless long_vrts2 were providing it for us, hardly any of us would find it or be aware of it.

    I wonder whether CLDX management, CLDX analysts and the FDA are aware of these auspicious articles that build the case, brick by brick, that CLDX is going to be a formidable commercial biotech company and also build the case that CLDX's value is not understood nor appreciated by the market.

    Really, at what point does good news translate into a much, much higher market capitalization? Seems to happen to many other biotechs, but not CLDX. Makes me continue to suspect that manipulation games or funny business is at work behind the scenes with this stock precisely because so many people know that it is going to be extremely successful and valuable before too much longer. The big players are positioning themselves for the biotech game of the decade, in other words.

    Sentiment: Strong Buy

  • Data just appeared on NASDAQ site today. Previously First Trust Advisors held no position in CLDX. The data represent the institution's holdings as reported on March 31, 2015. All institutions must report their holdings by May 15, on which date the IO percentage will finally be accurate once again after the secondary offering..

    Sentiment: Strong Buy

  • This is not a promotion that had to occur, nor did it have to occur today if commercialization is far off.

    Why would Marucci risk creating and announcing this new position if failure was a possibility or if commercialization is not fast approaching?

    Marucci knows Rintega is going to be commercialized this year.

    Sentiment: Strong Buy

  • Dershowitz: "This is a very sad day for justice. Today had nothing to do with justice; today was crowd control. Everything was motivated by a threat of riots and a desire to prevent riots. The mayor and the state attorney have made it virtually impossible for the defendants to get a fair trial: they have been presumed guilty. Today was crowd control, and there is an incompatibility between crowd control and justice."

    "There is no plausible, hypothetical, conceivable case for murder under the facts as we now know them. This is a show trial. This is designed to please the crowd."

    "They have invited a mess. What they did is barter short term results today for long term results in the future. My prediction: I think they've overplayed their hand. I think it's unlikely that they'll get ANY convictions in this case as a result of this, and if they do there's a good possibility that it will be reversed on appeal, and we'll just postpone the riots for months ahead. They have mortgaged the future for the present."

  • Reply to

    THE CEO SAYS THE DATA PASSED AND IS SOLID

    by rxkell May 1, 2015 10:27 AM
    whippersnapper65 whippersnapper65 May 1, 2015 10:41 AM Flag

    Yes, and that has been a reliable bread crumb trail to follow in the past: whenever Marucci has used that expression in relation to an upcoming presentation it has meant that the data were positive.

    It is also worthwhile to read or re-read the transcript from the CC on February 24, 2015 concerning end-of-the-year earnings. If you recall, that CC was held on the heels of the company announcing BTD for Rindo. The Q&A exchange with the analysts is especially worth reading carefully because the analysts had many questions about possible early approval for Rindo/Rintega based on final ReACT data that would be presented at ASCO. There are too many tidbits in the exchange to repost in this forum, but I will simply say that it is well worth taking another look at in order to understand management's plans.

    In summary, assuming the final ReACT data are consistent with November's near-final interim data (and the company expects the final data could be even better because quite a large number of patients in the Rindo arm had not yet experienced progressive disease), the investigational doctors have implored management to seek early approval from the FDA for the sake of their patients. Marucci states that the company has ramped up the commercial team to prepare for launch. A meeting with the FDA to see what the agency thinks of the final data would be held very soon once final ReACT data are in hand. If the final data are even better than what has been made public so far, the FDA would be hard-pressed to deny early approval of Rintega. Celldex already knows the data, and management is planning accordingly.

    Sentiment: Strong Buy

  • The subject is Ibrutinib (Imbruvica) by Pharmacyclics.

    Timeline:

    February 2013: Ibrutinib is granted BTD based on phase II data
    July 10, 2013: Pharmacyclics announces the submission of an NDA for Ibrutinib
    November 13, 2013: FDA approves Ibrutinib

    It can happen that quickly for Rintega too.

    Sources:

    (July 10, 2013) Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The submission was based on data from Phase II studies in patients with relapsed/refractory MCL and in patients with relapsed/refractory CLL/SLL. With this submission, Pharmacyclics is also requesting Priority Review. Pharmacyclics is jointly developing ibrutinib with Janssen.

    The NDA submission follows the receipt of a Breakthrough Therapy Designation from the FDA in February 2013 for ibrutinib as a monotherapy for the treatment of patients with relapsed/refractory MCL, and receipt of a second Breakthrough Therapy Designation for the treatment of patients with CLL/SLL with deletion of the short arm of chromosome 17 (del 17p). Further information on the implications of this filing for potential commercialization will be provided subsequent to the FDA rendering a decision on the filing.

    -----

    On November 13, 2013, the U. S. Food and Drug Administration granted accelerated approval to Ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

    The approval was based on the results of a multi-center, international, single-arm trial enrolling 111 patients with previously treated mantle cell lymphoma. The primary endpoint was overall response rate (ORR).

    Sentiment: Strong Buy

  • I believe this timeline is correct; if not, please correct any errors:

    May 30, 2008: Genentech presents phase II data at ASCO regarding Avastin in recurrent GBM
    November 3, 2008: Genentech submits BLA for Avastin in recurrent GBM
    May 5, 2009: FDA grants accelerated approval to Avastin for use in recurrent GBM

    As explained in the news item below, Avastin was approved for rGBM despite no evidence that Avastin eased disease-related symptoms or increased survival. The approval was granted on the basis of evidence of tumor response that usually lasted four months.

    Contrast that with Rintega, which has demonstrated statistically significant PFS6 and OS in rGBM EGFRvIII patients, eased disease related symptoms tremendously and produced no serious adverse side effects.

    Genentech filed for approval about five months after ASCO 2008 and Avastin was granted accelerated approval about eleven months after ASCO 2008. Breakthrough therapy designation did not exist at that time.

    Rintega has received breakthrough therapy designation, which ought to speed up the process that leads to approval, perhaps taking only half as long as it took for Avastin with poorer data. In that case look for NDA in July and approval by December.

    ----

    WebMD news archive:

    May 6, 2009 -- The FDA has approved the drug Avastin to treat a type of brain cancer called glioblastoma that progresses despite treatment with other therapies.

    Genentech, the company that makes Avastin, announced the FDA's approval, calling Avastin the first new treatment for glioblastoma in more than a decade.

    According to Genentech, the FDA based its approval on two clinical trials that together included more than 200 glioblastoma patients. Between 20% and 26% of patients showed a tumor response to Avastin that typically lasted for about four months.

    Genentech notes that no information is available from clinical trials showing that Avastin eased disease-related symptoms or increased survival among glioblastoma patients.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jun 23, 2015 10:44 PM Flag

    Without disagreeing with you, management also stated during the conference call on February 24 that it would only need to raise additional funds if it were going to pursue early approval for Rintega. What happened the very next day? An SEC filing for a secondary offering to raise additional funds. Management has known since mid-February that it would be applying for accelerated approval for Rintega, and I believe it had discussed the matter of raising additional capital for expenses related to accelerated approval with major institutions prior to its public announcement, which is why the secondary was priced and filled so quickly; it had been a done deal even before the announcement about BTD was made.

    Having had BTD since February, management has been in regular conversation with the FDA and receiving helpful assistance for four months already; management's description is that conversations have been "ongoing" with the FDA. I'm sure that includes topics pertinent to the timing of a possible NDA. So the six-month timeframe could have begun in March or April, by which time management had the complete data set for ReACT to give to the FDA. Portions of the NDA are probably already completed in anticipation of the FDA communicating what it would be amenable to (approval for rGBM only or that plus ndGBM). I don't think management is twiddling its thumbs waiting to begin the NDA.

    As we have commented on the message board many times, the big unknown is what the FDA wants to know about ACT IV and whether it will request to peek at blinded interim ACT IV data as a condition of considering Rintega for accelerated approval.

    It could be that the FDA has signaled it will accept an NDA for Rintega in both rGBM and ndGBM provided that the first interim ACT IV result is a "go" or (if the FDA wants to peek at the data) the results to date are consistent with phase 2 data with which the FDA is already familiar. In that case everyone could be waiting for the 50% event threshold.

    Sentiment: Strong Buy

  • These positions show an intent to expand in anticipation of having marketable products.

    1) Oncology Medical Science Liaison - Various Regions

    The Oncology Medical Science Liaison (MSL) is a field-based team member of the Medical Affairs organization. The MSL will prioritize contacts with key thought leaders (TLs) at medical centers within specific assigned regions of the United States, provide scientific exchange to critical stakeholders, and bring insights to the company.

    We are recruiting in the following regional areas:
    • Metro Northeast – New York City, PA, VA, MD, Washington D.C.
    • Southeast – KY, TN, AL, GA, FL, MS, SC, NC
    • Midwest – IL, OH, MI, WI, MN, IA, IN, MO
    • South Central – OK, TX, NM, AR, LA, KS
    • West – CA, AZ, NV, WA, OR

    2) Senior Director/Director Medical Affairs, Outcomes Research

    The Director/Senior Director will be responsible for the design and direction of epidemiology and outcomes research, focusing on PRO development and analysis, patient preference studies, risk prediction methodology, and prospective real-world study design, including post-approval prospective (and naturalistic) cohort designs. This person will have a solid understanding of how the above further support health economics evaluation, in turn supporting the value proposition for the Celldex portfolio in key global markets. The person will partner closely with Market Access colleagues, but drives the medical and scientific design of the studies. This person will define needs of data through a deep understanding of the changing landscape of outcomes research.

    3) Senior Director/Director Medical Communications & Publications

    Senior Director/Director Medical Communications & Publications (Hampton, NJ or Needham, MA)

    The Senior Director/Director will be responsible for developing strategies and tactical execution plans to engage health care professionals, medical organizations, patient advocacy groups and other groups involved in patient care via appropriate medical commu

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Apr 13, 2015 11:46 AM Flag

    Idiot: rindo already has BD.

    Sentiment: Strong Buy

  • An impression on Gray's head matches a bolt on the wall of the van.

    Liberals, you have been shown several times in recent events to have jumped the gun in criticizing police and stoking race riots, and now a handful of cities are smoldering because of your irresponsibility.

    That means you too, Mr. President. What a disgrace you are.

    No intelligent, mature, responsible, moral, dignified human being would have anything to do with the Democrat Party.

CLDX
25.48+1.13(+4.64%)Jul 6 4:00 PMEDT