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Celldex Therapeutics, Inc. Message Board

whippersnapper65 360 posts  |  Last Activity: 1 hour 15 minutes ago Member since: Jun 20, 2009
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  • Reply to

    Rich Broek joins BOD

    by long_vrts2 Dec 19, 2014 1:56 AM
    whippersnapper65 whippersnapper65 1 hour 15 minutes ago Flag

    Last week the FDA granted accelerated approval to BMS's nivolumab on the basis of evidence that was not as compelling as what Celldex has for Rintega. Nivolumab did not have a demonstrated survival benefit; accelerated approval was granted on the basis of percentage and duration of responses in a patient population that has few options and poor prognoses. Consistency in application and in ethical considerations would seem to dictate that the FDA grant accelerated approval to Rintega. Furthermore, whereas nivolumab has caused a significant number of severe adverse reactions in patients Rintega has caused virtually no adverse reactions.

    Accelerated approval and more is coming for Rintega. I maintain it should happen by mid-year 2015. If the FDA is really on top of things it could happen in 1Q 2015, as you believe.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 20 hours ago Flag

    Yes, the primary endpoint for the study was PFS6. Patients continue to be monitored for duration of PFS and for OS. Demonstrated efficacy in PFS6 is good enough in itself, but the fact that a statistically significant difference in OS has indisputably demonstrated Rindo's efficacy was unexpected and exciting. The study's PFS6 data will be complete in another 1.5-4.5 months, depending on how long the final patients take to progress in disease or until six months from the day the final patient was treated with Rindo. Duration of PFS and OS data will continue to be collected until the last patient in the study dies. Since the PFS6 data were the primary endpoint, and since the statistically significant OS is icing on the cake, ReACT is such a successful study for terminally ill, poor prognosis patients that the FDA would be hard-pressed to justify refusing to approve use of Rindo and Avastin in EGFRviii+ relapsed GBM patients.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 20 hours ago Flag

    In 2007/8 Celldex (a spinoff of Medarex) merged with Avant Immunotherapeutics in which shares of Celldex were exchanged for shares of Avant. Even though the combined company retained the name Celldex, in terms of common stock continuity the company is a continuation of Avant.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 21 hours ago Flag

    Possibly as soon as mid-February; it depends on the four remaining patients who have not reached the six-month mark since treatment in order to evaluate their PFS6. Longer is better, in a sense: longer overall survival would demonstrate Rindo is even more effective than it has already been shown to be, but longer is not necessary to demonstrate sufficient efficacy for approval. Efficacy has already been demonstrated to be statistically significant with p

    Sentiment: Strong Buy

  • Get ready to endure a lot of sleepless nights until you cover.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Dec 26, 2014 2:58 PM Flag

    Which is also why this stock has the #$%$ manipulated out of it. Institutions want to accumulate as many shares as they can from retail hands before the meteoric rise commences.

    Sentiment: Strong Buy

  • Reply to

    Target patient pop in rGBM

    by egkainia Dec 25, 2014 10:46 AM
    whippersnapper65 whippersnapper65 Dec 26, 2014 1:17 PM Flag

    My $300 million figure was for profit; yours was for sales. More deliberately misleading statements from you.

    It is obvious you are trying to spread FUD while ostensibly being new to the board and under the pretense of doing DD on Celldex. I see through you, as will others on this board.

    You are on ignore, so I won't read nor see any more of your posts. Merry Christmas.

    Sentiment: Strong Buy

  • Reply to

    Target patient pop in rGBM

    by egkainia Dec 25, 2014 10:46 AM
    whippersnapper65 whippersnapper65 Dec 26, 2014 11:28 AM Flag

    Accelerated approval of Rindo for relapsed GBM patients ought to be granted on the basis of statistically significant ReACT results. Simultaneous conditional approval of Rindo for front line treatment of GBM patients ought to be granted because efficacy in the more difficult relapsed setting indicates a strong likelihood of even greater efficacy in the front line setting, and the pivotal ACT IV trial is now closed to further recruitment; that conditional approval could be upgraded to full approval after ACT IV demonstrates statistically significant efficacy.

    What you fail to appreciate is that approval of Rindo on the basis of ReACT even for the smaller relapsed setting would be the first agency approval of Rindo and would transform Celldex into a commercial biotech. That agency approval would portend eventual (if not already simultaneously granted) approval in the front line setting in the U.S. and then globally.

    Management has projected worldwide sales of Rindo at $500 million annually. Even a conservative estimate of $300 million of that being realized as profit would result in over $3 earnings per share, which with a realistic multiple of 12 should produce a share price of $36 based on the value of Rindo alone. Other even more valuable assets in Celldex's pipeline would not be figured into that valuation.

    So your estimates and calculations are way off, so far off that it is not difficult for many longs on this board to suspect deliberate attempts to obfuscate and create irrational uncertainty. There are many such FUD posters on this board; we deal with them every day, which is why your post appeared to fit the same category. If your errors were honest rather than deliberate, I apologize for my curt accusations.

    Sentiment: Strong Buy

  • Reply to

    Target patient pop in rGBM

    by egkainia Dec 25, 2014 10:46 AM
    whippersnapper65 whippersnapper65 Dec 26, 2014 3:02 AM Flag

    1. The poster is bringing up a point made in 2010 without providing context. Here is some context:

    One of the most interesting pathophysiological studies performed by the authors was the study of EGFRvIII expression at tumor recurrence. In 11 patients who could have tumor samples evaluated both before and after vaccination, 82% lacked EGFRvIII immunoreactivity at recurrence. These studies are a true tour de force as the difficulties involved are truly challenging. The authors favor the interpretation that this indicates tumor escape, although at this stage it is impossible to differentiate tumor escape from loss of immunoreactivity because of the blocking of endogenous EGFRvIII immunoreactivity by the induced anti-EGFRvIII antibodies, or downregulation of EGFRvIII expression. Although the clinical progression of the disease would favor an interpretation of effective tumor control by the immunization followed by tumor mutation and escape, the absence of more detailed molecular studies and the low numbers involved preclude drawing definitive conclusions. In the future, analysis of comprehensive results from large-scale phase III, randomized, double-blind trials of patients with brain tumors immunoreactive for EGFRvIII will allow us to address the potential mechanisms of action of the EGFRvIII vaccine.

    ACT IV is such a phase 3 trial.

    2. The poster's contention that the target population for recurrent GBM is only 6% of all GBM patients is based on flawed reasoning. Recurrent GBM patients in the ReACT trial were not recurrent after having been treated with Rindo; they were Rindo naive. The 6% claim applies to patients who are recurrent after receiving Rindo and whose tumors continue to express EGFRviii. A correct statement or estimate of the patients eligible for Rindo in a recurrent setting would be more like 30%-40% of those recurrent patients, equivalent to those whose tumors express EGFRviii.

    Try again, shortie.

    Sentiment: Strong Buy

  • Gay blood donations should never be approved. You don't mess with anything that could taint the nation's supply of emergency donated blood. Political correctness and "feeling good" about not "discriminating" will not make tainted blood safe.

    Rintega should be approved pronto. You don't deny terminal patients the best hope they have for life with a proven safe, effective treatment.

    Sentiment: Strong Buy

  • Reply to

    SI Down Slightly

    by goforitmedx Dec 24, 2014 4:05 PM
    whippersnapper65 whippersnapper65 Dec 24, 2014 7:07 PM Flag

    When the short squeeze occurs it will launch CLDX to between $40 and $50.

    If the shorts had been closing their positions in a gradual and orderly manner, as they should have, since positive ReACT results were announced the share price would be over $30 right now.

    Shorting CLDX is an irrational, foolish, stupid decision even as a hedge.

    Sentiment: Strong Buy

  • Reply to

    Mybestbehavior is a liar and a phony

    by lba40 Dec 24, 2014 6:04 PM
    whippersnapper65 whippersnapper65 Dec 24, 2014 6:52 PM Flag

    I've had MBB on ignore for almost a year. I see that #$%$ still replies to my posts, but I don't read them. If he were intelligent he would have gotten a clue by now.

  • This low price is entirely unreflective of Celldex's worth. The ReACT news hasn't even made a difference in the stock's dominant intraday trading pattern.

    Sentiment: Strong Buy

  • Management has done almost everything right. There has been almost nothing but good news, and the good news ought to be resulting in a valuation of Celldex at around $3 billion right now. We longs know that, and management certainly knows that too.

    The day of CLDX's vindication will come like a thief in the night.

    Sentiment: Strong Buy

  • It would be opportune to announce those Nivo/Varli trials are commencing this week, while news of Nivo's accelerated approval is making waves.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Dec 23, 2014 2:02 AM Flag

    I should add that the case for accelerated approval of Rindopepimut is STRONGER than the evidence on which Nivolumab was granted accelerated approval.

    For one thing, ReACT provided statistically significant evidence of a benefit in overall survival for Rindopepimut patients, something that has not been demonstrated in the relevant Nivolumab trial yet, according to the press release.

    Furthermore, Rindopepimut has a much, much better safety profile than Nivolumab; the press release stated that there have been a rather large number of severe adverse reactions to Nivolumab. Nothing of the sort has been experienced with Rindopepimut.

    The case for accelerated approval of Rindopepimut is STRONGER than the evidence that supported accelerated approval of Nivolumab.

    Did you read that previous sentence, shorts? Read it, and understand it, and then realize that your days are numbered.

    Sentiment: Strong Buy

  • The following PR could easily be for Rindopepimut (Rintega) in the near future. The reasons given for accelerated approval of Nivolumab all apply to Rindopepimut.

    Monday, December 22, 2014

    PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) injection, for intravenous use. Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Metastatic melanoma is the deadliest form of skin cancer, and despite recent advances, there are limited treatment options available for patients who have been previously treated with approved agents.

    Sentiment: Strong Buy

  • Reply to

    HANG ON ...

    by bostonblackie02066 Dec 22, 2014 11:08 AM
    whippersnapper65 whippersnapper65 Dec 22, 2014 11:53 AM Flag

    They will have to settle for 99% because I and some others will not part with our shares.

    Sentiment: Strong Buy

  • Reply to

    Cyber Vandalism Mr. President

    by j20tower Dec 22, 2014 9:05 AM
    whippersnapper65 whippersnapper65 Dec 22, 2014 11:05 AM Flag

    Oh, and don't forget that this same administration refused to label Russia's invasion of Ukraine an invasion, for we signed a treaty to defend Ukraine against a Russian invasion. But BHO is so clever, just don't label an invasion an invasion, and then you don't have to honor the obligations of the treaty. When asked about whether the State Department had determined if the Russian action was an invasion, I believe the spokesidiot responded with something such as, "We have not determined whether it is an invasion, and we have determined that we do not need to make any determination about what sort of action it is."

    Same thing with racism: label something that isn't racism racism, and then you can whip up all sorts of mob frenzy that suits your political agenda.

    Oh, and labeling things that aren't marriages marriage is another liberal whopper of a lie.

    Liberalism is founded on lies, and liberals must lie about reality in order to make it appear that their fantasy worldview works. The problem is that you can't escape reality; eventually it will bite you in the #$%$.

    We have a president who is immature and irresponsible in refusing to recognize the reality of so much of what is going on domestically and internationally. Liberalism is a childish worldview, but liberals lie to themselves yet again by convincing themselves that they are so much smarter than conservatives, so much more knowledgeable, so much better able to handle the world. Of course, if they were honest about how immature and incorrect their worldview is, they would have to cease being liberals. They're not going to do that because they are unwilling to grow up.

  • Reply to

    Cyber Vandalism Mr. President

    by j20tower Dec 22, 2014 9:05 AM
    whippersnapper65 whippersnapper65 Dec 22, 2014 10:19 AM Flag

    From the same man who calls terrorism human-caused disasters. A common liberal ploy is that when reality doesn't fit your leftist fantasy agenda, you call things by a different name than they are so you can pretend that liberalism is working.

CLDX
18.24+1.16(+6.79%)Dec 26 4:00 PMEST

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