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whippersnapper65 329 posts  |  Last Activity: 13 hours ago Member since: Jun 20, 2009
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  • Reply to

    Takeover Price for Celldex (CLDX)

    by sb50pats May 27, 2015 9:50 AM
    whippersnapper65 whippersnapper65 Jul 15, 2015 1:09 AM Flag

    I think following approval of both Rintega and Glemba the share price will be at least $75 all on its own, especially if by that time positive phase I&II Varli/Opdivo combination trial data have been made public. At that point, any buyout would have to be in the neighborhood of $200 for the future sales of Rintega and Glemba and the potential of Varli, CDX-301 and CDX-1401.

    Sentiment: Strong Buy

  • Reply to

    BHO will now be known for

    by raysfrom98 Jul 14, 2015 10:37 AM
    whippersnapper65 whippersnapper65 Jul 14, 2015 1:38 PM Flag

    BHO gets a pass on everything from libs because he's black. No white man would have been permitted to be such a treasonous, inept and irresponsible president. If BHO were white his candidacy would have been savaged by the media. If he had somehow still been elected, he would have been impeached with the blessing of the media if he had been a white president. BHO is the first affirmative action president, and clear-thinking people know that affirmative action results in incompetent, unqualified people being hired and promoted so that libs can feel good about themselves for "righting" social "wrongs".

  • Reply to

    Volume Up Big - Price Up Big!

    by sooninjailinlasvegas Jul 14, 2015 1:01 PM
    whippersnapper65 whippersnapper65 Jul 14, 2015 1:05 PM Flag

    Look at ACAD, soaring to new highs today. I'll get excited when CLDX trades where ACAD is now; that's where CLDX deserves to be because CLDX is a much better company.

  • whippersnapper65 whippersnapper65 Jul 13, 2015 1:28 PM Flag

    Approval won't be granted prior to Celldex filing a NDA/BLA. I'm wondering when that announcement will be made. If Rintega will indeed be marketed starting in 1Q16, approval should be had in 4Q15, so the NDA/BLA should be filed early 3Q15, which is now. The sooner the better. I don't know what management could be waiting for; I understand completing the application takes time, but management has known since mid-February that it would be applying for accelerated approval (that was the reason for raising additional funds at the end of February and after BTD, after all), and here we are five months later with no NDA/BLA announcement.

    The stagnant share price for the past three months indicates that the market is waiting for clarification (but with confidence) from management regarding the timetable to Rintega's commercialization.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jul 11, 2015 10:07 PM Flag

    That makes sense now: the fact that there are more approved checkpoint inhibitors on the market. Thanks.

    Sentiment: Strong Buy

  • What follows are (1) the original criteria that were changed and then (2) the changes that were made on July 9. This info can be verified on the clinical trials website.

    Noteworthy among the changes is that the inclusion criterion of having had no more than four prior anti-cancer regimens has been removed; also, prior treatments must now include at least one checkpoint inhibitor (previously only ipilimumab).

    Anyone want to propose a theory about what these changes in the inclusion criteria mean?

    (1) Original criteria:
    -Disease progression during or after the last anticancer regimen received
    - No more than four prior anti-cancer regimens, including no more than 1 prior chemotherapy-containing regimen, for advanced (recurrent, locally advanced or metastatic) disease
    - Prior treatments received must include ipilimumab and for patients with a BRAF mutation at least one BRAF- or MEK-targeted therapy, unless patients are not candidates for, or refused, these therapies

    (2) Changes made on July 9, 2015:
    -Disease progression during or after the last anticancer therapy received
    - No more than one prior chemotherapy-containing regimen for advanced disease.
    - Prior treatments received must include at least one check-point inhibitor (e.g., Anti-CTLA4, PD-1, PD-L1-targeted immunotherapy) and for patients with a BRAF mutation at least one BRAF- or MEK-targeted therapy, unless patients are not candidates for, or refused, these therapies

    Sentiment: Strong Buy

  • Reply to

    S I Update

    by goforitmedx Jul 10, 2015 11:45 AM
    whippersnapper65 whippersnapper65 Jul 10, 2015 7:50 PM Flag

    When management announces the submission of an NDA those 16.5 million short shares are going to be big-time losers. Shorts are stuck: few willing sellers between this level and $35. Many of those shorts will be covering near $40 per share.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jul 8, 2015 11:00 PM Flag

    long_vrts2, what sense do you make of the Senior Director/Director Medical Affairs, Outcomes Research position? Why the need for a director of real-world and post-approval studies? Why wouldn't approval and the work of the medical science liaisons be enough? What would this additional position contribute?

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jul 7, 2015 12:35 AM Flag

    rays, as I responded elsewhere in this thread to another poster, I believe these new positions telegraph "MULTIPLE APPROVED, COMMERCIALIZED PRODUCTS".

    You are correct that nobody who follows the company should be caught off guard by an announcement about a submission for FDA approval. That announcement could happen soon.

    The ongoing discussions with the FDA must be going extremely well.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jul 7, 2015 12:31 AM Flag

    I believe management is aware of initial data from the Glemba and Varli trials, all of which are open-label and have been in progress for enough time for some data to have been collected. I further believe that those data are astonishingly good, possibly good enough to warrant accelerated approvals if the data remain consistent to the end of the trials. That would explain why management is creating such a large and well-organized and thorough sales/marketing/liaison/scientific force now, before the company has any marketable products. As you point out, it seems like overkill to build this sort of organizational structure if only Rintega sales are expected soon; Celldex is quite obviously planning and preparing now for future needs beyond Rintega.

    Furthermore, the description for the position "Senior Director Medical Affairs, Outcomes Research" includes responsibilities for planning phase IV, post-approval studies. Typically such studies would be required in the case of accelerated approval as confirmatory studies for full approval. The description also mentions the possibility of post-approval "real world" studies in order to better understand and target Celldex's treatments for patients. Unless you're anticipating a great need for post-approval studies, which by their nature presume FDA approval, why would you create a specialized position that includes such responsibilities?

    Everything about these newly posted positions screams "MULTIPLE APPROVED, COMMERCIALIZED PRODUCTS".

    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

  • Reply to

    Jim Webb is now running for the Dem nomination.

    by raysfrom98 Jul 2, 2015 2:21 PM
    whippersnapper65 whippersnapper65 Jul 2, 2015 2:33 PM Flag

    Bernie Sanders just drew a crowd of 10,000, the largest of any candidate in either party thus far.

  • whippersnapper65 whippersnapper65 Jul 1, 2015 10:20 PM Flag

    Marucci has been stating for at least a year that they have been assembling a global commercial and sales force so that when Rintega is commercialized the company can hit the ground running.

    Sentiment: Strong Buy

  • One likely reason to create the position of Chief Commercial Officer now is so that he can be present during an upcoming conference call as a member of the executive team in order to explain and answer questions about the company's commercialization plans for the launch of Rintega. Only senior VPs and higher disseminate official company information at such events.

    Follow the trail of bread crumbs to CLDX riches. The plan is in place; it just hasn't been disclosed yet. Everything is being arranged for the big event.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jul 1, 2015 11:23 AM Flag

    Mymandon, this news is another bread crumb on the trail for those who have the insight to grasp the total picture coming together for the destination to which Celldex is heading. Every move by Marucci since the promotion of Davis and Keler from senior VP to executive VP about this time last year has been telegraphing that the commercialization package for Rintega is being assembled. The creation of a new CCO position underscores that commercialization is imminent.

    Let those who have ears hear. Let those who have eyes see.

    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

  • Reply to

    Celldex Cancer Vaccine May Get Fast-Tracked part 1

    by beachpo Jul 1, 2015 7:37 AM
    whippersnapper65 whippersnapper65 Jul 1, 2015 8:35 AM Flag

    Dorkus will simply change his alias to something else after CLDX surpasses $40. Then he'll start the same short bashing B.S. all over again at a new fake price level. Dorkus isn't here for business reasons; he's here for the attention his mommy and daddy never gave him. That's why I recommend people put him on ignore. Ignore him and he'll go away.

  • whippersnapper65 whippersnapper65 Jul 1, 2015 8:13 AM Flag

    A move like this is not made and announced so publicly, with such glowing fanfare and optimistic verbiage in the press release, unless there are solid reasons for management to expect Rintega's imminent commercialization. This announcement signals that there have been many positive developments behind the scenes in discussion with the FDA that investors are not privy to yet.

    Sentiment: Strong Buy

  • Reply to

    7-8 CC Cantor 8:30 AM

    by cldx_58 Jun 30, 2015 4:29 PM
    whippersnapper65 whippersnapper65 Jun 30, 2015 9:33 PM Flag

    There ought to be a thorough discussion with pointed questions about management's progress regarding filing for accelerated approval for Rintega. Now that ACT IV's 50% event threshold has been passed with the expected positive result, nothing more stands in the way of filing for accelerated approval this year in rGBM and conditional approval in ndGBM. We have seen remarks by Oppenheimer today stating that the firm expects a BLA for Rintega to be filed sometime this year.

    Sentiment: Strong Buy

  • Reply to

    Did I hear that correctly?

    by raysfrom98 Jun 30, 2015 12:38 PM
    whippersnapper65 whippersnapper65 Jun 30, 2015 1:09 PM Flag

    BHO is going to get bolder and bolder in his violations of the Constitution and his oath of office as his term runs out. The two poorly decided Supreme Court decisions last week have given his ego and his resolve to transform Amerika a huge boost.

    In the meantime, Mooch and her kids are going to vacation all over the world on the taxpayer's dime.

    The most despicable family ever to occupy the White House is the Obama Family.

37.42+0.09(+0.24%)Jul 30 4:00 PMEDT