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whippersnapper65 5586 posts  |  Last Activity: Aug 27, 2016 10:36 AM Member since: Jun 20, 2009
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  • whippersnapper65 whippersnapper65 Aug 27, 2016 10:36 AM Flag

    Trademarkia com website.

    On the right side select search trademarks by owner, then enter Celldex.

    Sentiment: Strong Buy

  • In addition to requesting and receiving a trademark extension for "Glemva" (and Galembri and Garlemba -- all possible brand names for glemba), Celldex requested and received on August 10 trademark extensions for various Rintega logos; not merely the brand name "Rintega", but the logos with their distinctive typefaces and accompanying artwork.

    One could ask: if Rintega is dead, why would the company request trademark extensions for Rintega logos? Management must still believe that Rintega has a shot at commercialization.

    If glemba and Rintega produce surprises in October and November, it's going to be one heck of an exciting fourth quarter for this company and its share price.

    Sentiment: Strong Buy

  • On August 10 Celldex filed and was granted a trademark extension for the name "Glemva", obviously a brand name for glemba. The trademark had originally been secured in September 2015. A European Union trademark has also been secured.

    With Tom Davis' emphatic remarks about glemba in metastatic melanoma on August 8 and Elizabeth Crowley's promotion to a chief officer position on August 11, this occurrence on August 10 cannot be a coincidence.

    Much is brewing behind the scenes concerning glemba. We'll know in October.

    Sentiment: Strong Buy

  • Reply to

    New SVP of Product Development

    by maximus06906 Aug 11, 2016 9:19 AM
    whippersnapper65 whippersnapper65 Aug 26, 2016 3:20 PM Flag

    Yes, after reviewing today the filings pertaining to the merger between Celldex and CuraGen, I am confident that Elizabeth Crowley's promotion to a chief officer is strongly related to upcoming glemba results.

    Glemba (then CR011 at CuraGen) was Curagen's only promising candidate. Preclinical models in melanoma showed very promising results. Elizabeth Crowley was instrumental in guiding CR011 forward to obtain an IND and beginning phase 1 trials in melanoma.

    The documents reveal that Celldex was very interested in acquiring CR011 through the merger and that CuraGen believed CR011 could best be advanced to market with Celldex's resources and team.

    Crowley was probably the most knowledgable expert at CuraGen about CR011, and she has no doubt played a pivotal role as it -- now glemba -- has been advanced by Celldex not only in metastatic melanoma but also in other indications.

    In recognition of her important role in bringing glemba to Celldex and advancing it to the point where it might be approvable, Marucci promoted Crowley to a chief officer position in the company.

    Crowley's summer promotion fits the pattern whereby both Tom Davis and Tibor Keler received promotions in title the summer before the outstanding survival data in ReACT were presented in the fall of 2014. Only this time we are waiting for a fall presentation about glemba.

    Sentiment: Strong Buy

  • Reply to

    New SVP of Product Development

    by maximus06906 Aug 11, 2016 9:19 AM
    whippersnapper65 whippersnapper65 Aug 26, 2016 1:43 AM Flag

    I'm beginning to think that the promotion of Elizabeth Crowley to a "Chief" officer position might be related to what the company knows about the results of the glemba trial in metastatic melanoma that are scheduled to be presented in October.

    Crowley came to Celldex from CuraGen in the buyout in 2009, and at CuraGen Crowley was responsible for advancing glemba/CDX-011 (CR011-vcMMAE at CuraGen) in early clinical studies.

    Tom Davis has stated emphatically that glemba met and exceeded the ORR threshold in the metastatic melanoma study. The detailed results will have to wait to be released until October, but Tom seemed very enthusiastic and positive about the results.

    If glemba has performed superbly in melanoma such that the company could file for accelerated approval in metastatic melanoma (refer to discussion elsewhere on this board of the temporary/5-6 month hire in June whose job description included doing pre-BLA approval quality assurance work), Crowley would deserve a reward for her pioneering work with glemba at CuraGen, for glemba might turn out to be Celldex's inaugural product rather than Rintega.

    Sentiment: Strong Buy

  • Reply to

    QA admin position

    by btchinvstr Jun 17, 2016 5:30 PM
    whippersnapper65 whippersnapper65 Aug 24, 2016 7:09 PM Flag

    And if an asteroid had smashed into Washington, D.C. or New York I would have been wrong too.

    The anomalously outperforming control arm in ACT IV is that type of unforeseeable event (but not on the same scale) and is the reason CLDX is in the doldrums. Nobody predicted the control arm significantly outperforming all medical precedent, nobody expected it, and it remains to be explained why and how it occurred. CLDX naysayers believed Rintega would underperform compared to phase-2 trials because they believed there was selection bias in the open-label phase 2 trials that exaggerated Rintega's efficacy. Turns out Rintega performed exactly is it has, even in a blinded trial. Turns out Rintega does work.

    CLDX naysayers got lucky. That's it. Sometimes luck strikes to your benefit, but luck isn't a strategy.

    Every piece of evidence, from phase-2 to ReACT results to long-term survival to FDA breakthrough therapy, pointed to smooth sailing of Rintega into approval. An astonishing anomaly derailed the Rintega train. Maybe management can put the train back on track; we'll see.

    I still remain confident that the company's pipeline is solid, the best in immunotherapy, and will be successful and highly profitable. Shareholders will reap tremendous gains; it will just take longer than all the evidence originally indicated.

    Sentiment: Strong Buy

  • Reply to

    QA admin position

    by btchinvstr Jun 17, 2016 5:30 PM
    whippersnapper65 whippersnapper65 Aug 24, 2016 5:20 PM Flag

    dummyexpress, you moron, YES Celldex stopped the trial upon the recommendation of the DSMB because the control arm and the Rintega arm were roughly paralleling each other in OS. That decision was announced on March 7. That wasn't because Rintega performed poorly; it was because the control arm anomalously and unexpectedly outperformed all precedent.

    The FDA did not stop the trial.

    Every indication is that Rintega offers 50% better median OS than standard of care. In ACT IV, the standard of care arm inexplicably performed 40%-50% better than any other set of similar patients. The data analysis currently underway will attempt to determine why. Had the control arm performed normally, Rintega would be on the road to approval right now.

    Even still, Rintega patients are the longest-surviving EGFRviii+ GBM patients on the planet -- the "tail" on the survival charts that have been a point of discussion and pride, showing Rintega patients surviving 7-10 years, which is unheard of in GBM. That should count for something in such a difficult to treat, terminal disease. Rintega+Avastin showed statistically significant OS in relapsed patients versus Avastin alone. The evidence that Rintega works is strong. Whether it is strong enough for the FDA despite ACT IV not meeting its primary endpoint is the big question; but another endpoint besides survival could suffice for approval as long as Rintega has been conclusively shown to provide superior outcomes in a clinically meaningful endpoint.

    The curtain hasn't closed on Rintega. Listen to the company's response to the first question in the CC on August 8, as sr420steve suggested.

    If the company can produce the data and advance the arguments that persuade the FDA to approve Rintega, management will have earned every option and dollar they have been given and paid. If Rintega ends up being shelved, the company's next prospects in glemba and varli have great potential.

    CLDX isn't dead, and the share price is ridiculously low.

    Sentiment: Strong Buy

  • Reply to

    QA admin position

    by btchinvstr Jun 17, 2016 5:30 PM
    whippersnapper65 whippersnapper65 Aug 24, 2016 2:45 PM Flag

    A high ORR in the melanoma trial would bode well for glemba in other indications too and increase expectations for a successful pivotal METRIC TNBC trial, which would lead to approval in TNBC. Glemba's ADC seek-and-destroy technology would be shown to work well.

    Sentiment: Strong Buy

  • Reply to

    QA admin position

    by btchinvstr Jun 17, 2016 5:30 PM
    whippersnapper65 whippersnapper65 Aug 24, 2016 2:42 PM Flag

    sr420steve is right, lucky: you are an idiot and everyone knows it.

    Rintega performed exactly as Tom Davis and the rest of management predicted. The problem in ACT IV was with the control arm outperforming by 40%-50%, which nobody is on record as having predicted because it deviated so largely from prior medical knowledge.

    Sentiment: Strong Buy

  • Reply to

    QA admin position

    by btchinvstr Jun 17, 2016 5:30 PM
    whippersnapper65 whippersnapper65 Aug 23, 2016 11:56 PM Flag

    Tom Davis' remarks -- twice -- during the earnings conference call that the trial of glemba in melanoma exceeded the ORR threshold and that even more patients might progress to a measurable response as the data mature might be a clue that, as you suggested, the data are good enough to support an AA application. The addition of another cohort to test the ADC in combination with varli means they want to see whether the synergy produces even better results.

    Data will be presented in October, which will be five months after the temp position was filled. The timing and subsequent remarks by management are consistent with your theory.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Aug 23, 2016 3:15 PM Flag

    You used to be on ignore, but that's no longer an option on this board. Pity.

    This will be my only response to your idiocy.

    Celldex has funds and time for glemba and varli to prove their worth. If only one of those two succeeds, the share price will be back in the $30s swiftly. Prior trial data offer good reasons for optimism about both of them.

    Glemba and varli each separately dwarf Rintega in their market potential and potential profitability. Rintega's value was primarily that it would have provided a source of funding to make Celldex profitable while it continued to develop the more valuable agents in its pipeline. There may yet be a resurrection of Rintega, depending on what the analysis of ACT IV data uncovers. Even if not, Celldex is hardly in a death spiral. If you believe that, you haven't studied the company's pipeline.

    The stock price has taken a beating. This too shall pass.

    Sentiment: Strong Buy

  • Reply to

    Some Interesting Volume the Last Two Days

    by maximus06906 Aug 22, 2016 4:44 PM
    whippersnapper65 whippersnapper65 Aug 22, 2016 6:15 PM Flag

    If management were exercising the right to sell the remaining equity allotment under the Cowen agreement, would that show up in market volume? Letting Cowen buy shares at this low price before good news in the months ahead?

    Sentiment: Strong Buy

  • Reply to

    New Glemba paper just published

    by fludyspnea Aug 17, 2016 11:56 PM
    whippersnapper65 whippersnapper65 Aug 18, 2016 1:41 AM Flag

    In the conference call you reference, Tom Davis was EMPHATIC about stating and reiterating that the results in the glemba melanoma trial exceeded the minimum threshold. He really seemed eager to stress that point clearly so that nobody missed it.

    Thank you for posting the news about glemba.

    This board really has gone to hell. Good to see a CLDX post amidst the cacophony of lame-brained political posts.

    Sentiment: Strong Buy

  • Reply to

    Glemba TNBC delayed 13 months

    by biggypharma Aug 13, 2016 10:42 PM
    whippersnapper65 whippersnapper65 Aug 14, 2016 5:58 PM Flag

    No, Rintega isn't dead. Tom Davis said that Rintega is still an active program, that the company is still communicating with the FDA, and that the company would decide how to proceed after the ACT IV data analysis is complete.

    We shall see, indeed.

    If some anomaly is discovered in the control group that explains why it outperformed all historical precedents by 40%-50%, it ought to be easy for Celldex to receive approval.

    Or perhaps an endpoint other than overall survival would be sufficient to receive approval. The company has a new chief legal counsel who is an expert in regulatory law; he should be a tremendous help in exploring every possibility.

    We know Rintega works. It's just a matter of convincing the FDA of that. Hopefully there is something in the data that will be sufficient.

  • Reply to

    Glemba TNBC delayed 13 months

    by biggypharma Aug 13, 2016 10:42 PM
    whippersnapper65 whippersnapper65 Aug 13, 2016 11:59 PM Flag

    That's only half the story: in December 2013 Tom Davis projected that enrollment would be completed within 12-18 months with a primary outcome data readout six months after that, which would have been mid-late 2015. Had the company fully enrolled the trial within the original timeframe and subsequently released positive data, glemba could have been on the market by now.

    Sentiment: Strong Buy

  • It is worth paying very close attention to Tom Davis talk about all the clinical trials Celldex has in progress and planned for later this year. The explanations about the glemba, varli, CDX-1401 and CDX-301 programs take up the bulk of the conference call. They are extremely informative and reveal that great care has been taken by the scientific and medical teams to select agents and targets and potential combination therapies that will have wide and robust applications. Tom sounds like a nerdy kid in a candy store describing all of Celldex's agents and the various ways in which they are being tested and combined.

    Note too that Tom was EMPHATIC about repeating a previous statement in responding to a question about the glemba melanoma trial. When a questioner asked about glemba meeting the endpoint in the melanoma trial, Tom pointedly reiterated that he had said that the trial had met and EXCEEDED its specified threshold of responses and that when data from the trial are presented in October he would be able to be more specific about the number and types of responses in the study. Sounds like he has something he's eager to reveal but can't yet.

    I don't see how anyone listening to the conference call can fail to understand that Celldex has a unique and potentially very powerful and extremely valuable asset pipeline. It will take time for the agents to be proven in studies, but if they are -- and if they all are -- Celldex is going to be one heck of a valuable company. It's frustrating that Marucci wants to go it alone, but I sort of understand why he is so hard-nosed about that. I believe he, Tom and Tibor are convinced that the world doesn't realize what Celldex owns and just how valuable the assets will turn out to be. People don't understand combination immunotherapy the way those guys do.

    Give them time. ACT IV was a setback, but will turn out to have been merely a speed bump if management is right about Celldex's pipeline and about combination therapy.

    Sentiment: Strong Buy

  • Reply to

    TMF

    by raysfrom98 Aug 12, 2016 2:02 PM
    whippersnapper65 whippersnapper65 Aug 12, 2016 2:04 PM Flag

    I just read that article too. Interesting that the author states that Glemba in TNBC should be a slam-dunk.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Aug 12, 2016 1:35 PM Flag

    Ray, I agree.

    If Varli delivers it will be worth the wait.

    I don't blame management for what happened with ACT IV, but the failure to enroll METRIC completely by this time is a significant fumble by management. Glemba can still deliver, but the delays are costing a lot of money.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Aug 12, 2016 11:54 AM Flag

    Recall that in September 2014 the company amended the trial protocol because of slow enrollment. This summer management has stated twice that enrollment is not proceeding as quickly as hoped because the TNBC space is a competitive one right now; patients have lots of trials to choose among. The company believes the recent expansion into Europe with new trial centers will boost enrollment.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Aug 12, 2016 11:51 AM Flag

    Let us know what you hear.

    When I wrote to IR after the agreement was first disclosed I was told that it was just a part of having the house in proper order.

    My bet is that Marucci wants a financial runway through the end of 2018 and is planning to sell shares under the agreement incrementally to extend the company's cash at least that long rather than waiting until late 2017 or early 2018 to sell shares in one large amount.

    Sentiment: Strong Buy

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