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Yahoo! Inc. Message Board

whippersnapper65 105 posts  |  Last Activity: Oct 6, 2015 1:08 PM Member since: Jun 20, 2009
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  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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

    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

  • If Varli is the key to ramping up the body's immune system to fight cancer and will work with existing therapies to make them more effective, then the name VARLIMMUNE would say it all.

    Sentiment: Strong Buy

  • Reply to

    Let's take a breather at $28

    by mymandon Jul 15, 2015 10:04 AM
    whippersnapper65 whippersnapper65 Jul 15, 2015 12:47 PM Flag

    No: if CLDX takes a "breather" somewhere it ought to be at $38 (previous all-time high). CLDX has spent more than enough time below $30 to base for a substantial rally.

    Sentiment: Strong Buy

  • When faced with the cold, stark reality that fantasy-based leftist economics leads to national economic collapse and a resulting breakdown of civil society, Tsipras matured and wised up fairly quickly in order to save his country. Would that America's leftists would learn that lesson and mature and wise up before America becomes imperiled as Greece is.

  • Reply to

    One Hell Of A Close

    by sooninjailinlasvegas Jul 17, 2015 5:46 PM
    whippersnapper65 whippersnapper65 Jul 17, 2015 6:08 PM Flag

    Um, no, if CLDX were trading at ACAD's levels, that would be one hell of a close. CLDX trading below $40 (not to mention below $30) right now is lamentable with all of the positive pipeline developments that have occurred this year and with Grexit worries overcome.

  • whippersnapper65 whippersnapper65 Jul 17, 2015 7:21 PM Flag

    Black lives matter but babies' lives do not, especially not if they're black babies, who are aborted at astonishingly high rates.

  • Reply to

    One Hell Of A Close

    by sooninjailinlasvegas Jul 17, 2015 5:46 PM
    whippersnapper65 whippersnapper65 Jul 17, 2015 10:22 PM Flag

    And how much on paper have you lost since the share price was at $30 prior to ASCO's excellent data presentation about two months ago? And are you "pretty damn happy" about that?

    I don't mean to insult you; we're on the same team as far as believing in CLDX is concerned. Where we differ (and I differ with the other frequently cheerleading longs about this too), is that I don't see the point nor do I understand the satisfaction in shaking pompoms and taunting "Doris" (et alia) whenever CLDX has an occasional modest daily or weekly gain while ignoring the larger context of abysmal share price action for the past three months. It seems that every other biotech company with half as much going for it as CLDX has had better share price action than CLDX. If any other biotech company had the news and pipeline that CLDX has had it would be trading at $40 right now; it should be trading at that level right now.

    Sentiment: Strong Buy

  • Reply to

    Cramer says Celldex isn't worth more than a trade

    by mymandon Jul 17, 2015 10:39 PM
    whippersnapper65 whippersnapper65 Jul 18, 2015 12:32 AM Flag

    All of the reasons Cramer stated in 2013 for buying CLDX were true then, and they are even more solidly true now, two years later. The fact that you can buy CLDX for only $27 today is startling when it is on the verge of commercialization, has a pipeline of extremely promising and potentially highly lucrative drugs, and is in a field in which smaller companies are being gobbled up for billions of dollars each by big pharmas that want to beef up their cancer immunotherapy assets for the coming immunotherapy revolution.

    We don't need Cramer. Cramer will tell his lemmings to buy CLDX when it's trading over $50 and he rediscovers its revolutionary potential.

    Sentiment: Strong Buy

  • From the May 31 press release:

    "As previously guided, if updated data remained consistent with previously reported results, the Company intended to discuss the potential significance of the ReACT study with regulatory bodies. Given the consistency of the results, this process is ongoing, and the Company will communicate the outcome of these discussions when they are completed."

    I'm wondering how frequent and how productive the company's meetings with the FDA have been, and how many more meetings and how much more time it will take before the "ongoing" discussions are completed. What reasons could the FDA have for delaying or discouraging a formal application to approve Rintega?

    ReACT data are impressive, worthy of approval because Rintega is proven better than standard of care. ACT-IV passed its first interim analysis with a "go" decision. There are long-term Rintega survivors from phase-2 trials in an otherwise acutely terminal cancer. BTD was granted, meaning the FDA officially agrees Rintega is promising and treats a patient population in dire need of effective therapies. Celldex has the commercial manufacturing facilities and capability to produce sufficient quantities of Rintega.

    Really, how long does it take for bureaucratic eggheads and pencil-pushers to reach the inescapably obvious conclusion? What good is BTD for a candidate like Rintega if the "ongoing" discussions are not completed within one more month, resulting in a communication to Celldex that the FDA would receive a BLA for Rintega favorably?

    With a candidate like Rintega, delaying its availability to patients becomes the irresponsible course of action.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jul 20, 2015 1:45 AM Flag

    I have to believe that given such results management is doing everything within its power to advance Rintega to accelerated approval. Any delay is probably a consequence of the FDA's bureaucratic constraints or inefficiencies. For the FDA not to move as expeditiously as is humanly possible toward approving Rintega is irresponsible and in contravention of the purpose for which the FDA exists.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jul 20, 2015 3:50 AM Flag

    Mymandon, Re: "One I think compelling option the FDA has potentially available that I consider possible would be to designate Rintega the first immunotherapy with a “biomarker-specific treatment approval” that would allow for conditional approval of Rintega to be marketed for ALL EGFRviii+ cancers (not just GBM). The market doesn’t give this possibility a chance, but I think the data warrants it. "

    I believe that possibility should be given more credence based on the posting less than two weeks ago of a new job opening on Celldex's website for a Senior Director Medical Affairs, Outcomes Research. That position's responsibilities include planning post-approval and phase IV trials, which would be needed if Rintega were to be granted the unprecedented approval for all EGFRviii+ cancers conditionally pending confirmation of benefit and efficacy in suitable post-approval trials in indications other than GBM.

    You are correct that the market is completely disregarding that possibility. Were it to occur, it would probably cause the share price to jump over 100% both because of the revolutionary surprise and the short squeeze.

    Perhaps your suggestion has been a line of discussion in the ongoing communications between the FDA and Celldex management.

    Sentiment: Strong Buy

  • Reply to

    The Lowest Volume I've Seen

    by j20tower Jul 20, 2015 12:21 PM
    whippersnapper65 whippersnapper65 Jul 20, 2015 12:41 PM Flag

    Yes, CLDX is behaving even more strangely than before. It's still being heavily controlled, and obviously major institutions (that own 90% of the shares) are not interested in selling. But why is it not rallying?

    Sentiment: Strong Buy

  • Reply to

    One Hell Of A Close

    by sooninjailinlasvegas Jul 17, 2015 5:46 PM
    whippersnapper65 whippersnapper65 Jul 21, 2015 2:22 PM Flag

    As I said last week, days like today (down about 3.5%) happen all too often with CLDX after some modest gains, which is why I've discouraged people from shaking pompoms whenever CLDX manages a 2% gain or has a series of small green closes. You only set yourself up for being laughed at and you provide food for the board trolls.

    Sentiment: Strong Buy

  • Reply to

    John Boehner Orders Flags At Half Staff

    by j20tower Jul 21, 2015 11:14 AM
    whippersnapper65 whippersnapper65 Jul 21, 2015 4:30 PM Flag

    The man in the White House hates America, the Constitution, Christians, white heterosexual males, white heterosexual females, conservatives, the military, American exceptionalism, the free market and capitalism, Israel.

    But the man in the White House said, "God bless Planned Parenthood."

    Would you want such a man as your friend? Would you want such a man as your leader? The man is a total disgrace and has done untold harm to American society and our economy. The American future has been imperiled by BHO.

32.37+0.50(+1.57%)Oct 8 4:00 PMEDT