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whippersnapper65 198 posts  |  Last Activity: 9 hours ago Member since: Jun 20, 2009
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  • Reply to

    ASCO next week

    by grey3840 10 hours ago
    whippersnapper65 whippersnapper65 9 hours ago Flag

    Ray, I can't help you feel better about the pace of enrollment. All we have to go on is management's guidance that it expects to complete enrollment by the end of this year, which is in line with what it has been saying for quite a while.

    However, there is this interview with Dr. Yardley and Dr. Vahdat about METRIC and Glemba that was published in January. In that interview Dr. Yardley states that METRIC's enrollment was almost half total accrual. It surprised me that as of December/January the trial still would not be over the halfway mark for patient accrual.

    www (dot) onclive (dot) com/publications/Oncology-live/2016/January-2016/novel-antibody-drug-conjugate-explored-in-tnbc

    Sentiment: Strong Buy

  • Reply to

    ASCO next week

    by grey3840 10 hours ago
    whippersnapper65 whippersnapper65 10 hours ago Flag

    Remember that last year's ASCO program had a full-page color ad for Rintega featuring an intimidating-looking snake and touting Rintega in EGFRviii GBM. Not that same level of excitement this year.

    Looking forward to the 301 and 1401 results and hoping for something that will lead to a resurgence of interest in the company's well-cultivated pipeline while we wait for METRIC to complete enrollment. New European sites for that trial open to recruitment every several days.

    Still wondering what the VP/SVP of Global Regulatory Affairs position is all about and what Marucci is sitting on or anticipating or planning for the rest of the year.

    Sentiment: Strong Buy

  • Reply to

    Back in CLDX

    by richrd_cc May 25, 2016 9:56 PM
    whippersnapper65 whippersnapper65 May 26, 2016 12:12 AM Flag

    richard_cc, were it not for the fluke of the outperforming control arm in ACT IV CLDX would be once again trading near those all-time highs right now. Glemba will get us back there.

    Beware, there are very few posters worth reading on this message board. I believe I have about 90% of the regular posters on ignore.

    Sentiment: Strong Buy

  • Reply to

    frankfrazzano is on ignore

    by whippersnapper65 May 24, 2016 10:48 AM
    whippersnapper65 whippersnapper65 May 24, 2016 12:18 PM Flag

    businessforme144: When you hover over a message, the word "Flag" will appear with a downward pointing arrow to its right. Click on the word "Flag" and a drop-down menu will appear with an option to ignore user.

    Ignoring the message board clutterers will be a lot of work if you haven't done any of that work already because there are so many fools and spammers who post here, but it's worth it to have a clean message board; saves you time by hiding the posts from the people whose messages aren't worth reading.

    Sentiment: Strong Buy

  • whippersnapper65 by whippersnapper65 May 24, 2016 10:48 AM Flag

    Sorry, Frank, you know I agree with you in general about politics and Celldex, but your posts have recently become just too inane and too frequent and they clutter the board. If there's ever big company news I'll read what you have to say in relevant message threads, but until then I'd prefer to have a clean message board view that only displays posts worth reading, and I've concluded that that means I must ignore you. Best of luck to you.

    Sentiment: Strong Buy

  • Obviously, when Celldex hires someone for this position he will come from a major drug company. The requirements that the successful candidate have a medical doctoral degree plus over ten years of experience in regulatory drug development, including product approval and launch and a proven track record in bringing new products to market, means that Marucci will have to send head hunters out to poach someone from a drug company who has been long-established and successful in his work there.

    Another consideration is that no viable candidate would consider leaving his comfortable, established, secure job to work at a development-stage biotech company whose former lead product just failed its phase three trial unless that person is convinced by Marucci, Davis and Keler that Glemba and Varli have data to support highly confident conclusions about their likelihood of being approved. What successful candidate in the prime of his career is going to risk flushing his future away by leaving a secure job to work at an unknown company with one big trial failure in its recent history?

    Such a candidate would be very expensive to hire in the first place, and even more expensive when you consider that a candidate will have to be enticed away from his current position to take on a new job at a company that could be perceived as high-risk. The person who is hired could probably demand at least $200k in salary plus an immediate generous grant of incentive stock options, for such a person could argue that he would be the linchpin to guide Celldex into becoming a commercial biotech company without whom the company would risk unsuccessful regulatory bids for approval.

    Now an investor would have to ask himself: why would Celldex be seeking such a candidate and how could it expect to entice a high-quality candidate to accept the job unless management had undisclosed information that supports both the creation of the position and the expectation that someone will want to fill it?

    Sentiment: Strong Buy

  • Reply to

    Shorted more, CLDX going RED!!!

    by unclecldxizz May 20, 2016 3:55 PM
    whippersnapper65 whippersnapper65 May 20, 2016 4:01 PM Flag

    Sigh. Another idiot to ignore. The only thing to do with a piece of sheet like you is to flush you out of sight.

    Sentiment: Strong Buy

  • It's nearing the time for management to show investors the drugs instead of showing them the money.

    Sentiment: Strong Buy

  • Reply to

    Why raise capital now?

    by ithinkpeoplearecrazy May 19, 2016 4:24 PM
    whippersnapper65 whippersnapper65 May 19, 2016 4:35 PM Flag

    The company is not obligated to sell shares. It's $60 million worth of additional available financing, should it be necessary. I hardly think management would sell shares now to raise money since it has plenty of funds in reserve. If management were to sell shares now, it would be fishy; perhaps a prelude to a buyout and part of a sweetheart arrangement for someone to make a quick, tidy profit.

    I think this is insurance for the future and a signal to the markets that now Celldex has financing to last through the end of 2018, if needed to secure Glemba's or Varli's commercialization. It is also a signal that Marucci still wants to go it alone, unless the shares are sold right away.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 May 19, 2016 3:33 PM Flag

    Ray, I'm not going to read Cy's post (he's on ignore), but from your account it seems he told a tall tale of his patronizing leftist beneficence toward a minority individual.

    How many "hate crimes" against minorities and homosexuals have been hoaxes perpetrated by minorities and homosexuals themselves in order to be able to cry "victim"? It seems more the rule than the exception that such incidents, after investigation, turn out to be hoaxes. Two were in the news recently, including the Whole Foods allegation.

    Similarly, leftists will exaggerate or fabricate tales of their beneficence toward the underprivileged in order to call attention to themselves and to make themselves feel good for their bleeding hearts.

    Leftists are narcissists -- it's part of the mental disorder -- and they don't value the truth, so what's a little lie or even a big lie if it will promote the leftist agenda and make them feel good about themselves and garner attention from people? In their minds, there's nothing wrong with lying to get what they want.

  • whippersnapper65 whippersnapper65 May 19, 2016 9:14 AM Flag

    Frank, it's not an "anti-LGBT" boycott; it's a pro-sanity boycott of Target, a pro-women's and pro-children's safety boycott, a pro-science and pro-truth boycott, and anti-political correctness boycott. Who would have ever thought that in America the simple, obvious, biolgical truth that there are two different sexes and that they should have separate showering and restroom facilites out of respect for their differences and for considerations of modesty and safety would be called into question? Well, it is being called into question in modern leftist Amerika. This is one of the rotten fruits of the insidious deision to consider homosexuality normal instead of pathological. Errors in the premises lead to even bigger errors in the conclusions drawn from those premises. Now every sexual deviancy imaginable is being touted as a lifestyle or identity that everyone else must respect, honor and celebrate or else face a penalty and punishment.

    Enough! No more!

    Time to push back against political correctness and the destrictive insanity of the left in America.

    Time to reclaim ground that the left has captured in the culture wars.

    Time to make America great again.

  • Reply to

    Rintega compassionate use

    by biggypharma May 18, 2016 7:18 PM
    whippersnapper65 whippersnapper65 May 18, 2016 7:32 PM Flag

    I believe the expanded access trial was initiated before ACT IV was stopped for futility as a way for GBM patients to have access to Rintega after ACT IV had been closed to new patients. At that time Celldex management was expecting ACT IV to succeed and reasoned that REACT 2 wouldn't be necessary because it was thought that the combined ACT IV and REACT data sets would support approval for Rintega in relapsed GBM patients as well as in newly-diagnosed GBM patients. With the failure of ACT IV, that plan dissolved. The expanded access trial is a leftover from they heyday of optimism about ACT IV; it is not a newly-initiated program.

    Sentiment: Strong Buy

  • Reply to

    ASCO CDX 301/1401 Abstract

    by fludyspnea May 18, 2016 5:42 PM
    whippersnapper65 whippersnapper65 May 18, 2016 6:11 PM Flag

    Celldex has a strong pipeline. The pre-clinical and science guys clearly have done their homework.

    301 and 1401 are early-development assets, and even good news probably won't wake investors up to how absurdly undervalued CLDX is right now. The market is concerned that the company will run out of money before Glemba or Varli can be commercialized.

    If Glemba, Varli, 1401 and 301 all make it, Celldex will be an extremely valuable company. Varli alone would catapult Celldex into the stratosphere of biotech valuations.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 May 18, 2016 2:17 PM Flag

    SR420, when you can't argue the facts, when you're confronted by a superior argument that proves you are wrong, a loser like you changes the subject and resorts to ad hominems and imagined fictions about your interlocutor.

    Have fun reading all those Celldex ASCO abstracts when they are released today!

    Fool.

    You can't admit when you're wrong. You need to change that character flaw about yourself if you're going to get anywhere in life.

    You are on ignore.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 May 18, 2016 1:19 PM Flag

    Ha, ha, ha. Not only are you wrong, you are so clueless that you shouldn't be investing in this sector, SR420.

    An FDA approval would not be announced at ASCO; ASCO isn't the forum for such an announcement. The minute Marucci received a letter of approval from the FDA he would have IR put together a press release to be disseminated that same day. That sort of material information would be announced immediately. The company wouldn't wait to make such an announcement at a scientific conference. Produce the quote and the occasion for its occurrence, if you insist that Marucci said such a ridiculous thing.

    The FDA does not respond to trials ending, which is what you claimed. Now you are changing your words to mean the FDA would respond to questions from the company following the trial's conclusion. Sorry, you can't change your original statement's meaning. Although the company can communicate with the FDA on an ongoing basis because Rintega has been granted BTD, that would have to be initiated by the company; FDA-initiated communication does not happen automatically after a trial ends.

    Okay, when abstracts are released later today, please tell us all which ones submitted by Celldex are available for viewing. Then tell Celldex IR that the company has ASCO abstracts because IR believes the company hasn't submitted any abstracts for consideration at ASCO this year. There will be one abstract involving a Celldex treatment, but that abstract was submitted by the trial sponsor, which is not Celldex.

    I bought at prices even lower than today's absurdly low share price years ago. I cashed out some shares at much higher prices and then repurchased shares as the price declined this year. I will hold all of my shares to realize another lucrative profit.

    Go invest in a sector you understand and in a company you know something about.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 May 18, 2016 9:34 AM Flag

    Were JFK alive to see the Democrat Party turn into an American communist party today, he would publicly disavow that party and join the Tea Party conservatives.

  • whippersnapper65 whippersnapper65 May 17, 2016 11:37 PM Flag

    You don't know what you're talking about. Marucci NEVER stated that approval would be announced at ASCO; that's not what ASCO is for. Furthermore, the FDA doesn't respond to trials ending; it responds to BLA submissions. Lastly, Celldex will not be presenting anything at ASCO this year, not even ACT IV data.

    In the eighteen months prior to March 7, 2016 Celldex management had been speaking and acting (ramping up commercial preparations and sales staff) as if ACT IV success and Rintega's subsequent approval were virtually assured. One week before the failure of ACT IV, Tom Davis stated in response to a question that stopping the trial for futility was virtually impossible and not at all expected to occur. Then the "impossible" happened. Management needs to come clean in the sense that it needs to explain to investors what went wrong that was so unexpected and why management didn't foresee or couldn't have foreseen the control arm performing so far above any expectation that it would ruin the trial even though Rintega performed exactly as it was expected to.

    Although ACT IV has been discontinued and Rintega seems stuck, Rintega still appears in the company's pipeline of treatments. Management needs to explain what its plans for the future of that asset are.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 May 17, 2016 5:15 PM Flag

    More to the point: what is the point of this expanded access trial if it will not result in nor contribute to a pathway to approval? Why have it or why continue it? If Rintega works (and we know that it does), then the FDA should just approve it already; if the FDA doesn't think Rintega works, then why are there expanded access trials that administer a supposedly ineffective treatment? I could understand having expanded access trials when other Rintega trials were closed and it looked like Rintega was on its way to approval, but expanded access trials now don't make much sense if they will not contribute to eventual regulatory approval.

    Management needs to come clean with shareholders soon about the future of Rintega's potential as a commercial product and what it has learned about what went wrong in ACT IV.

    Sentiment: Strong Buy

  • Reply to

    What I love about the Obama era ...

    by investwith6s May 17, 2016 3:03 PM
    whippersnapper65 whippersnapper65 May 17, 2016 3:37 PM Flag

    The angriest and most destructive people in America today are leftists, and for eight years they have taken marching orders from the Leftist in Chief.

    Time to make America great again.

  • FMR, the largest institutional owner of CLDX, finally reported its ownership as of March 31. Seems the failure of ACT IV did not dissuade FMR from continuing to believe in CLDX's long-term success: FMR sold only 131,000 shares from its holdings and retained over 14.6 million shares.

    Overall, after all the 1Q institutional activity, the total IO percentage fell by a little, not much. There were some IOs that sold out, matched more or less by IOs that took new positions. Some IOs decreased their positions, but that was almost matched by those that increased theirs.

    The setback with Rintega will merely be a bump in the road. It was the least potentially valuable component of the pipeline, anyway, whose importance lay more in that it would provide a source of revenue to fund development of the rest of the pipeline comfortably.

    Good news regarding Glemba or Varli will send CLDX back into the $20s and $30s quickly.

    Sentiment: Strong Buy

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