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whippersnapper65 109 posts  |  Last Activity: 1 hour 15 minutes ago Member since: Jun 20, 2009
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  • whippersnapper65 whippersnapper65 Sep 23, 2016 2:06 PM Flag

    You got that right.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Sep 23, 2016 2:02 PM Flag

    The science guys at Celldex have chosen their targeted therapeutics well. I wish that would be coupled soon with a commercial success. It's frustrating to wait years and years for the first success, even more frustrating to see other, lesser companies reach that success on weaker data than what Celldex has already demonstrated.

    Celldex has the pipeline to be a biotech behemoth, but it's still trying to break out of the R&D egg.

    Sentiment: Strong Buy

  • Reply to

    October 2013 - today Do we invest the wrong stock???

    by aqnguyen Sep 22, 2016 10:17 PM
    whippersnapper65 whippersnapper65 Sep 22, 2016 11:25 PM Flag

    If you had asked that question in February 2016, the answer would not have been so clear: the share prices were fairly close to each other. Much can change in a short time in biotech stocks. The only reason SRPT is trading so much higher now than it was in February is because of good news from the FDA based on a study with n=12. Amazing.

    If Celldex announces good news on October 10 about glemba in metastatic melanoma (and we know that it won't be bad news because management has already stated that the trial has exceeded the target ORR, but we don't know by how much the target was exceeded), then CLDX will experience another bullish run, most especially if the ORR is considered good enough to apply for accelerated approval with the FDA. The glemba market in all indications is enormous, and demonstration that glemba is working in gpNMB+ melanoma will increase confidence that it will also work against other gpNMB+ cancer types; after all, gpNMB is gpNMB, wherever it is located, and glemba seeks it out to destroy cells that express it.

    Couple that with the possibility that Celldex could decide to apply for approval of Rintega after the company announces the results of its ACT IV analysis at SNO on November 17, and there is potential in the fourth quarter for CLDX to have an impressive bullish run in a short period of time, similar to what SRPT has done over the past six months.

    That is why I continue to maintain that CLDX is a strong buy.

    Sentiment: Strong Buy

  • Reply to

    The Animals Once Again Burning and Looting

    by j20tower20 Sep 22, 2016 9:21 AM
    whippersnapper65 whippersnapper65 Sep 22, 2016 1:55 PM Flag

    Every riot by miscreants, every Islamic terrorist attack on America, helps convince more people to vote for the Law and Order presidential candidate: Trump.

  • Don't know whether that decision was made before ACT IV was stopped for futility or after. If Rintega were a bust, I doubt Celldex management would continue to pay $40,000 per year to be a SNO sponsor. One could ask what would be the point and what would Celldex gain from a sponsorship if its neuro-oncology treatment was not going to advance any further.

    The 15-minute slot reserved for ACT IV during the plenary session on the opening day of the SNO annual meeting should be interesting.

    Sentiment: Strong Buy

  • ACT III -- note, not ACT IV -- was the subject of a very peculiar protocol change on August 9 of this year. This would have gone unnoticed by me because I usually only look at open trials for changes, but today I decided to check completed trials; glad I did.

    Here are the protocol changes:

    1) In the descriptions of the investigative therapy, EVERY occurrence of CDX-110 by itself was replaced with the descriptor "CDX-110 with GM-CSF". (That change corresponds to the descriptions used in the trial protocols for both ACT IV and ReACT.)
    2) An arm description, "Maintenance temozolomide plus intradermal injections of CDX-110 with GM-CSF." was removed from the protocol.

    Isn't it odd that protocol changes would be made to ACT III so many years after the trial completed enrollment and after the study has been completed? Why bother?

    This strikes me as window dressing for a BLA submission based on what the company has learned in its analysis of ACT IV data: the company appears to be setting the stage for making the case that "CDX-110 with GM-CSF" is the active therapeutic agent and that data from numerous trials supports whatever they have confirmed in the analysis of ACT IV about Rintega's efficacy (administered with GM-CSF). Why else would the company bother to make such a protocol change to an old trial such as ACT III so that the description of the drug matches the descriptions used in both ACT IV and ReACT?

    It might be worth mentioning, too, that the date of the protocol change is only one day after the Q2 earnings CC.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Sep 19, 2016 12:39 PM Flag

    If the ACT IV data presented at SNO in November show a long-term survival benefit in 15%-25% of Rintega patients similar to what has occurred in every prior trial of CDX-110, I would hope that management would seek approval on that basis, making the case with the FDA and EU that immunotherapy takes longer for its benefits to become apparent than is the case with conventional treatments. There's no disputing Rintega's safety, and the data consistently show its long-term efficacy in a significant subset of patients that is literally life-saving.

    Sentiment: Strong Buy

  • Reply to

    Anybody know about this?

    by grey3840 Sep 16, 2016 10:09 PM
    whippersnapper65 whippersnapper65 Sep 16, 2016 10:58 PM Flag

    It comes up on the clinical trials site when you search for trials by Celldex, but it's not a Celldex Therapeutics trial. Last I recall, it is for a diet drug and the name of the trial is Celldex (contraction of Cellodextrin).

  • Reply to

    Cy on ignore

    by mcschafer Sep 16, 2016 12:48 PM
    whippersnapper65 whippersnapper65 Sep 16, 2016 1:21 PM Flag

    How do you do that? I don't see an option to ignore users anymore. Ever since Yahoo switched to the new message board format but kept this site operating, all of the users I had put on ignore over the years became visible once again, with no option to ignore them.

  • This overlooked: on July 27, among the protocol changes to the glemba in metastatic melanoma trial that were made (adding a second cohort to test glemba in combination with varli) was this statement: "Patients in cohort 2 must submit a recently obtained biopsy of the skin fold for gpNMB analysis."

    We have read patient accounts of skin rashes, varying in severity. Celldex has been aware of that side effect and has reasoned that the intensity of the skin rash correlates with the levels of gpNMB in a patient's skin cells. With the added requirement that patients in the newly added cohort 2 must have their skin analyzed for gpNMB, the company seems to want to be able to study that correlation.

    All of which supports the belief that glemba is working: attacking gpNMB+ cells wherever they are, which means it is showing efficacy in killing gpNMB+ cancer cells. Glemba could very well surprise positively in October and eventually have wide application. I believe the promotion of Elizabeth Crowley to a chief officer is a harbinger of glemba's success because Crowley was instrumental in guiding glemba through early development at CuraGen prior to its acquisition by Celldex. Glemba might be Celldex's inaugural product.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Sep 15, 2016 5:39 PM Flag

    If glemba works in targeting and killing gpNMB+ cancer cells wherever they are, the potential for glemba in treating uveal melanoma is strong, as this study concluded regarding the presence of gpNMB in uveal melanoma tumors.

    GPNMB expression in uveal melanoma: a potential for targeted therapy. (Melanoma Res. 2010 Jun;20(3):184-90.)

    Eighteen of 21 tumors evaluated immunohistochemically (85.7%) expressed GPNMB in 10-90% of tumor cells with variable intensity (5 tumors, 1+; 11, 2+; and 2, 3+). Eleven of 18 tumors (61.1%) expressed GPNMB in or=50% of cells. Spectral imaging showed diffuse CDX-011 (unconjugated) reactivity in the remaining case. Uveal melanoma, like cutaneous melanoma, commonly expresses GPNMB. Ongoing clinical trials of CDX-011 should be extended to patients with metastatic uveal melanoma to determine potential efficacy in this subset of patients with melanoma.

    Sentiment: Strong Buy

  • Reply to

    Glemba questions

    by carlrich Sep 14, 2016 11:37 AM
    whippersnapper65 whippersnapper65 Sep 15, 2016 11:45 AM Flag

    Partnering Glemba would make a lot of financial sense after Rintega's setback and the collapse of the share price. Management is loaded up with options (many currently out of the money), would prefer not to dilute in order to raise more revenue to fund operations for years after 2018, and revenue from a partner and from Glemba sales would give the company footing to develop its pipeline further (especially Varli) without the burden and expense of creating its own sales force for Glemba's multiple indications.

    Sentiment: Strong Buy

  • Reply to

    Glemba questions

    by carlrich Sep 14, 2016 11:37 AM
    whippersnapper65 whippersnapper65 Sep 14, 2016 9:25 PM Flag

    Regarding your speculation that Celldex is considering partnering Glemba, perhaps this is relevant.

    Quite a few of the job openings are for validation posts. There is also a newly-hired temp consultant (see Rich Yeaton on LinkedIn) who states that since June he has been helping Celldex to demonstrate Part 11 compliance of automated GMP production equipment.

    Part 11 concerns the acceptability of electronic records in place of paper records for submission to the FDA.

    It could be that Celldex is simply proactively upgrading their entire manufacturing and record keeping processes to migrate to complying with federal electronic storage and submissions regulations, but that seems like a time-consuming and costly upgrade without either a marketable product on the horizon or a partnership that is conditioned upon Celldex being able to comply with Part 11 for records maintenance, sharing and submission to the FDA.

    Anyone with thoughts on the significance of Celldex pursuing and hiring for Part 11 compliance at this time?

    Sentiment: Strong Buy

  • Reply to

    Glemba questions

    by carlrich Sep 14, 2016 11:37 AM
    whippersnapper65 whippersnapper65 Sep 14, 2016 1:06 PM Flag

    Management has not guided that METRIC will completely enroll in 1Q 2017; during the August 8 CC it stated that when the pace of enrollment in the newly-opened (as of summer) European trial centers is more clear in the fall it will be able to provide guidance about an expected timeframe for full enrollment.

    METRIC's primary outcome measure is PFS6, which would be sufficient for approval, assuming a positive result. Those data would be available six months after fully enrolling the trial, so not a long wait.

    Sentiment: Strong Buy

  • Reply to

    Clinton News Network losing it

    by investwith6s Sep 11, 2016 6:06 PM
    whippersnapper65 whippersnapper65 Sep 11, 2016 7:56 PM Flag

    Ray, Dr. Drew Pinski DID lose his job on Headline News (a CNN affiliate) because he spoke publicly about his concerns about Hillary's health. His show was canceled. The official story is that the two had nothing to do with each other, but that defies reason.

  • Reply to

    Another anecdote about glemba in TNBC

    by whippersnapper65 Sep 8, 2016 8:52 PM
    whippersnapper65 whippersnapper65 Sep 9, 2016 12:16 AM Flag

    Fludy, thanks for posting the additional information about Ms. White. It hadn't occurred to me to look for subsequent stories about her, but it makes sense that there would be ongoing national interest in her story because it's unique and touches the heart and gives encouragement to women diagnosed with breast cancer, TNBC in particular.

    In the article that you found, it also stated that White enrolled in the glemba study in December 2015. So by now she's surpassed the EMERGE trial data's median PFS and OS for glemba in gpNMB+ TNBC patients as well as surpassed METRIC's hypothetical median PFS (6.25 months).

    She seems to be responding quite well to glemba. I, too, hope the treatment continues to remove the cancer from her body. Imagine how effective her publicity would be!

    If White's response is common in the glemba arm, approval should be straightforward. Celldex just needs to get the trial completely enrolled already!

    The effectiveness of glemba against White's cancer also gives reason to believe that the melanoma trial data to be presented in October will be very positive. Glemba targets gpNMB, so it stands to reason that if it's working in high-gpNMB TNBC it should also work in other indications whose cancers also express high levels of gpNMB.

    Sentiment: Strong Buy

  • whippersnapper65 by whippersnapper65 Sep 8, 2016 8:52 PM Flag

    Stage 4 cancer diagnosis inspires woman to become Mrs. West Virginia

    Jul 17, 2016

    ... That's when White knew it was cancer. She saw a breast surgeon the following week, and had surgery the week after that - skipping the biopsy altogether. After the lumpectomy, it was determined to be triple negative breast cancer. She chose to have a bilateral mastectomy with reconstruction. She also had five months of chemotherapy from August to December of 2014 and 28 radiation treatments.

    For the better part of 2015, White was cancer free. They moved into a new house and she did a lot of lifting and painting and moving furniture, and noticed that her arm was sore where her lymph nodes had been taken out. She had been told to favor that arm, so she hoped that maybe the pain was just from overuse. Then a knot popped up on her chest.

    "They took me to have an ultrasound, and within 30 to 40 minutes I was going to see Dr. Traylor to have an emergency biopsy," she recalled. "I knew right then that it was back. You kind of always hope (that it's something else)."

    It was Stage 4. It had also traveled to her lung and spine, though that cancer in her spine has since been eliminated with a new clinical trial in which she's participated at the Cleveland Clinic. A scan in May indicated that her cancer was no longer responding to chemotherapy, but the new treatment she's getting through the clinical trial, CDX-011, seems to be shrinking the tumors.

    "When I had the PET scan in June, there was no cancer in my spine, and the place in my chest and the place in my lung had shrunk after two infusions," she said.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Sep 8, 2016 12:43 PM Flag


    She is thoroughly unqualified to be President ethically and professionally, thoroughly unhealthy for the role, thoroughly incapable without teleprompters or handlers telling her what to do and what to say. She doesn't love America; she just wants to be in history books as the first female President. She will be even more destructive than BHO has been.

  • Reply to

    9-7-16 Form 4 filed @ CLDX

    by long_vrts2 Sep 7, 2016 4:28 PM
    whippersnapper65 whippersnapper65 Sep 7, 2016 8:11 PM Flag

    Steve, you are correct and the message board bonehead is wrong. The bonehead stated that Catlin acquired the shares via options vesting, which Catlin clearly did not do. As you correctly stated, Catlin partially exercised an option, which means he had to pay his own money in order to acquire those shares to directly own them instead of derivatively own them. As you also pointed out, by doing so now with the share price so low, Catlin reduces his tax liability for exercising the option because of the small difference between the strike price and the current share price.

    Catlin has been doing this with Celldex options every so often for the past two years; check the history of SEC filings under his name. He exercises options whose strike price is just below the current market price, which means he pays his own money to buy the shares, and then he holds the shares rather than sells them. The only reason to do that is because you have reasons to believe the share price will appreciate; and by holding the shares for at least one year Catlin would qualify for a long-term capital gain tax rate on any future gain instead of paying tax at the ordinary income rates.

    By exercising and not selling, Catlin is actually taking on additional risk because he's putting his own money into exercising options, which he doesn't have to do; he could just hold the options.

    I'm sure Catlin is even more frustrated with the low share price than we are. He's the oldest executive officer at Celldex (67), been in the biotech business for a long time, and I'm sure he expected that Rintega's success in ACT IV would have produced the Celldex windfall that he's clearly still expecting eventually. He wants to stay with the company to enjoy its commercial success milestone, and he wants to collect his windfall reward for a life of hard work, then enjoy his golden years very, very comfortably.

    Sentiment: Strong Buy

  • Reply to

    Form 4 Filed...

    by mybestbehavior Sep 6, 2016 1:20 PM
    whippersnapper65 whippersnapper65 Sep 6, 2016 6:13 PM Flag

    Keler, Davis, Marucci, Wright, Crowley, Catlin and Pepin should each be buying 30,000 shares at this price level instead of only 3,000. How about the board of directors too? Ellberger bought 20,000 shares a year ago when the share price was in the teens. He's probably smarting over that, but now's a good time to buy more at a very low price.

    Sentiment: Strong Buy

42.08-0.47(-1.10%)Oct 26 4:00 PMEDT