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whippersnapper65 238 posts  |  Last Activity: 13 hours ago Member since: Jun 20, 2009
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  • Reply to

    Clinical Updates

    by hokiestock12 Jan 13, 2016 5:12 PM
    whippersnapper65 whippersnapper65 Jan 13, 2016 5:26 PM Flag

    Oh, please: have you not been paying attention to what has been happening in the rest of the stock market or to other biotech company share prices? ACAD announced a secondary offering priced at $29 just last week and now it's trading at $23. You write as if CLDX is the only stock to have dropped dramatically since the start of the year.

    The drop in CLDX has nothing to do with anything pertaining to the company nor its assets.

    You might have some valid questions and concerns if the market were booming. As it is, your questions and concerns evince a complete lack of awareness or grasp of what is going on.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 13, 2016 11:23 AM Flag

    No, you are forgetting the likelihood of initial data releases this year from the Varli combination trials with BMS.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 11, 2016 8:11 PM Flag

    Yes, your revised remarks are correct. Thank you for correcting yourself. We don't need misinformation on the board,especially not with the share price absurdly low. Management has guided that it has sufficient cash to last through 2017. That is consistent with the burn rate.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 11, 2016 7:25 PM Flag

    You don't know what the ^%$@# you're talking about. One more asinine remark from you and you'll be banished to Ignoreland.

    Sentiment: Strong Buy

  • whippersnapper65 by whippersnapper65 Jan 11, 2016 3:37 PM Flag

    Way oversold. Bought more at 11.65 in addition to what I bought on Friday at 12,95.

    I'm not as skillful as Frank at buying at the very low of trading, but the prices were good enough for me.

    I will make a handsome profit, and so will anyone else who was wise enough to buy shares over the past week, especially today.

    Sentiment: Strong Buy

  • Reply to

    New job posted: eTMF Administrator

    by whippersnapper65 Jan 11, 2016 11:22 AM
    whippersnapper65 whippersnapper65 Jan 11, 2016 11:36 AM Flag

    An electronic Trial Master File (eTMF) isn't necessary for regulatory submission; paper files are adequate. What this new position demonstrates is Celldex management's long view: they are planning for multiple regulatory filings in the years ahead, which an eTMF system will make more efficient. It is possible that the regulatory filing for Rintega will be done the old fashioned way, so this position isn't necessary to fill before filing for Rintega's approval.

    Sentiment: Strong Buy

  • whippersnapper65 by whippersnapper65 Jan 11, 2016 11:22 AM Flag

    This is a brand-new position because the description states that the person hired will participate in selecting the eTMF that Celldex will use. Celldex is preparing for regulatory submission, naysayers be damned.

    -----

    Overview:

    The eTMF system is an electronic document repository system supporting clinical studies document collection, organization and filing. The eTMF administrator plays a key role in ensuring the complete TMF is available as required for compliance with government regulatory agencies.

    Position responsibilities:
    •Performing a gap analysis of our current Trial Master File (TMF) processes and identifying opportunities for efficiency with the transition to an eTMF solution.
    •Participating in the review and selection of the eTMF solution for Celldex.
    •Working with internal IT and the selected vendor to ensure system requirements are well defined and implemented.
    •Participating in any user acceptance testing to be completed.
    •Taking the lead on development and / or revision of any standard operating procedures and working process documents needed to support the incorporation of an eTMF into the Clinical Operations workflows.
    •Developing system training materials and delivering eTMF training to the CRAs, CTAs, CTMs and GCPLs.
    •Proactively maintaining the eTMF moving forward, including monitoring of usage, reviewing for accuracy, identifying potential challenges (system-related or workflow related) and driving system adoption and usage.
    •Conduct Quality Control of clinical documentation to ensure e-TMF inspection readiness.
    •Acting as a departmental super user of the system serving as a key contact for questions and system issues.

    Sentiment: Strong Buy

  • Reply to

    OVERSVILLE

    by martyboy0077 Jan 11, 2016 11:06 AM
    whippersnapper65 whippersnapper65 Jan 11, 2016 11:10 AM Flag

    You've been banished to Ignoreville.

  • Reply to

    Bottom Area

    by raymondnmc Jan 9, 2016 3:31 PM
    whippersnapper65 whippersnapper65 Jan 9, 2016 5:12 PM Flag

    I agree, which is why I bought more on Friday to hold until the success of ACT IV is announced, which could occur as soon as this month.

    Sentiment: Strong Buy

  • Give up the charade, liberals. Muslims are a problem; they are the most serious problem in the world right now. How many more explicitly Islamic jihadist attacks will it take before you admit Islam is incompatible with Western societies and United States security?

  • whippersnapper65 whippersnapper65 Jan 8, 2016 4:37 PM Flag

    And liberals think that way despite clear and compelling evidence to the contrary. How many more attacks explicitly in the name of Islam have to be carried out before liberals will give up the "Islam is a religion of peace" garbage? They are fools for maintaining that stance and for repeating that line after every Islamic jihadist attack. Liberalism is a mental disorder. Liberalism prevents you from grasping the truth. The day a liberal admits that Islam is not a peaceful religion is the day that liberal takes a step toward becoming a conservative.

  • whippersnapper65 whippersnapper65 Jan 8, 2016 4:02 PM Flag

    Liberals live in an imaginary world in which Islam is a peaceful religion. The rest of us live in reality where Muslims are an individual and national security threat because Islam is a scourge on humanity.

  • I already own a lot. Used to own twice what I own now, but I sold some when the price was higher to realize a lucrative gain from purchases made when the share price was below $5. Planned to hold the remainder, also bought for under $5 per share, for another 5-10 years or until buyout.

    The price collapse this week is unjustified. Maybe the price will go lower, but I don't think it will go much lower. I bought more shares today at $12.95 to hold until the news that ACT IV has been a successful trial is announced. Just seems too good of a trade to pass up; too good of a money-making opportunity.

    Good luck to all longs.

    Strong buy means buy all you can afford to purchase.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 7, 2016 1:12 PM Flag

    I think if the second interim analysis doesn't occur until March, that would exceed even management's estimates and indeed be tremendously positive. I believe management has been expecting a December-January timeframe. I would love to have coffee with Celldex's chief statistician and pick his brain about the hypothetical scenarios they have been running in their in-house projections.

    Sentiment: Strong Buy

  • Reply to

    As a praticing clinition:

    by martyboy0077 Jan 7, 2016 11:32 AM
    whippersnapper65 whippersnapper65 Jan 7, 2016 11:52 AM Flag

    Wouldn't a practicing clinician be able to spell correctly the word that refers to his profession? Otherwise, I agree.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 7, 2016 9:50 AM Flag

    The referenced "Junior Accountant" position is described as "new" by the company. To wit: "The Finance Department at Celldex Therapeutics in Needham, MA is seeking a qualified candidate to fill a new Junior Accountant position."

    So some accountant in a suit in the finance department doesn't want to do all the boring data entry and paperwork and filing anymore. He requested a junior assistant to do all that, and management agreed. Management didn't say, "Let's wait until we have a revenue stream and can afford that sort of luxury for your department." A Junior Accountant position is not a high priority, not necessary for advancing the company's commercial aims; it's a convenience for a more senior-level accountant.

    Without a revenue stream, one could conclude that creating new junior-level assistant positions is a sign that the company is either extremely confident or else is getting fat-happy. I'd like some reassurance and evidence from management that there is good reason for the former.

    Sentiment: Strong Buy

  • The company keeps hiring. There had better be a damn good reason for it, and we'd better know by the end of the month. If ACT IV is stopped early for efficacy, Marucci will look like a genius, but he's playing a very high-stakes game with investors' money by building up the company infrastructure tremendously for commercialization without having a product to sell yet. He's stated that he wants the company to be able to hit the ground running upon FDA approval of Rintega; well, the company is moving its legs pretty fast and at great cost in the air and it's high time for the company to land and start running.

    Many of us long-time longs are getting weary of the languishing share price that always seems to be the victim of global or sector circumstances that have nothing to do with the company.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 5, 2016 10:47 AM Flag

    I believe that treatment is Optune by Novocure, and it was approved in October 2015 on the basis of the referenced study, which was stopped early in 2014 for efficacy.

    Optune is a mechanical device worn on the scalp that delivers low-intensity electricity into the brain. You can see pictures of models wearing the device and read about it at the website optune dot (com).

    From the website: "Optune is designed to be worn continuously throughout the day and night and is portable, so it allows you to go about your daily activities while receiving treatment. Optune should be used for at least 18 hours a day to get the best response to treatment."

    Seems to me that's a rather large inconvenience. Additionally, if you look at the models wearing the device on the Optune site, the device looks strange; it would definitely be something a patient would be self-conscious about.

    Furthermore, there are some significant side effects: "The most common (≥10%) adverse events involving Optune in combination with temozolomide were low blood platelet count, nausea, constipation, vomiting, fatigue, scalp irritation from device use, headache, convulsions, and depression. The most common (≥10%) adverse events seen when using Optune alone were scalp irritation from device use and headache. The following adverse reactions were considered related to Optune when using the device alone: scalp irritation from device use, headache, malaise, muscle twitching, fall and skin ulcer."

    Contrast the negatives of having to wear an electrical device visibly on your skull for at least eighteen hours a day and the side effects from its use with Rintega's convenient injection with no significant side effects, and for EGFRviii+ GBM patients, at least, Rintega is clearly a preferable treatment option; not to mention Rintega's demonstrated long survival tail extending out over ten years now for some patients, which Optune does not have.

    Optune is not a threat to Rintega.

    Sentiment: Strong Buy

  • Reply to

    Low Volume

    by goforitmedx Dec 31, 2015 2:11 PM
    whippersnapper65 whippersnapper65 Jan 3, 2016 4:08 PM Flag

    If Rintega's statistical efficacy doesn't meet or surpass the threshold you mentioned, management will not be told how Rintega is performing versus the control arm. If the predetermined statistical threshold for stopping the trial early for efficacy isn't met, no data will be released to management: the trial will simply continue with a "go" recommendation from the DSMB.

    So management will not have any idea how well Rintega is performing in comparison with the control arm unless the trial is stopped early or until the trial reaches its conclusion later. Therefore, unless the trial is stopped early for efficacy, management will have no ACT IV trial data to use in a submission for regulatory approval with the FDA.

    I believe management is waiting for the imminent outcome of the 75% event threshold in ACT IV before deciding how to proceed with the FDA regarding Rintega. If ACT IV is stopped early for efficacy, it is simple: management will speedily file for Rintega's approval in both nGBM and rGBM on the basis of ACT IV data and ReACT data. In that scenario breakthrough therapy designation would hasten the FDA's review of the application documents, and approval in both settings would be in the bag. If ACT IV is not stopped early but continues to its eventual end, I believe management should file for approval in rGBM on the basis of the most current ReACT data and all the other data from other Rintega trials that were the basis for receiving breakthrough therapy designation. The long-term survival data for ReACT patients released in November was even better than previously expected. Management isn't proceeding with a regulatory submission in rGBM at this time on the basis of ReACT because it is hoping that ACT IV will be stopped early for efficacy within a matter of weeks, at which point it will have a slam-dunk case for approval in both nGBM and rGBM. I believe management is strategically waiting for an iron-clad case to make with the FDA.

    Sentiment: Strong Buy

  • Reply to

    Low Volume

    by goforitmedx Dec 31, 2015 2:11 PM
    whippersnapper65 whippersnapper65 Jan 1, 2016 8:14 PM Flag

    Your question probably has an answer, but I suspect that only Celldex statisticians would be in a position to provide it.

    For one thing, no previous trial of Rintega (Rindopepimut/CDX-110) in nGBM has featured a control arm; all early-phase trials of Rintega used independent historical data sets as controls for the purpose of evaluating Rintega's median and long-term survival results. Rintega has always and consistently compared favorably to such historical controls. ACT IV is the first trial of Rintega in nGBM to have a simultaneous control arm in a randomized, double-blind study. To answer your question would require compiling and evaluating data from multiple independent studies; those are data to which Celldex statisticians would have access, and they would be paid by the company to perform the complex statistical analyses that might provide the answer to your question.

    ReACT was the first trial in which Rintega was tested against a control population in a randomized, double-blind study. However, that study was in rGBM patients, not nGBM, so the results are irrelevant in answering your question regarding ACT IV even though Rintega demonstrated statistically significant survival efficacy in ReACT.

    At least one institution (I can't recall which one) has estimated that ACT IV has a 65% of being stopped early for efficacy at the second interim look. Some knowledgeable posters on this board have estimated the chance of success as being 70%.

    Sentiment: Strong Buy

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