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ONYX Pharmaceuticals, AŞ Message Board

whippersnapper65 352 posts  |  Last Activity: 14 minutes ago Member since: Jun 20, 2009
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  • Reply to

    delay in Metric study?

    by tradetph 2 hours 10 minutes ago
    whippersnapper65 whippersnapper65 14 minutes ago Flag

    With METRIC being a pivotal trial and Celldex management desperately needing a score as cash dwindles after the fumble with Rintega, I don't think management would wait for a conference late in 2017 to announce METRIC's data if they are positive and would support regulatory approval. Management should and could simply host a conference call in 2Q 2017. Waiting to present at a conference is an obsolete practice in the internet age.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 20 hours ago Flag

    I tend to agree with those who have stated that the most strategic VP running mate for Trump would be New Mexico Governor Susana Martinez. Whomever he picks as his running mate will be very telling.

  • The column is titled, "A Dark Time in America".

    ... at no other time has there been as much pessimism — valid pessimism, moreover — about America’s future as there is today.

    Among the reasons are:

    Every distinctive value on which America was founded is in jeopardy.

    Find the article and read it; it's an accurate diagnosis of what ails America.

  • whippersnapper65 whippersnapper65 May 4, 2016 10:52 AM Flag

    What happens when the 1Q earnings release states that the company burned $35 million from January through March? The company was revving in high hear to prepare for commercialization of Rintega, and the bad news didn't come until the end of the first week in March. All that Rintega commercialization spending has been money flushed down the drain. Unless management can convince investors that it has the goods to succeed and has an effective plan to succeed, the cash burn rate is going to be like cement shoes on a man trying to swim up to the surface to take a breath.

    BTW, management seems to be delaying the 1Q earnings release.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 May 2, 2016 4:37 PM Flag

    Yet to be seen. It's being valued as worthless, if the share price is any measure.

    Sentiment: Strong Buy

  • Reply to

    OKD, Mbb, Honkey

    by dollarbill848 May 2, 2016 3:47 PM
    whippersnapper65 whippersnapper65 May 2, 2016 4:05 PM Flag

    The valuable contributors on this message board have placed those three on ignore besides many others.

    Sentiment: Strong Buy

  • Reply to

    the marxist

    by rumbleinstreet May 1, 2016 8:54 PM
    whippersnapper65 whippersnapper65 May 1, 2016 9:30 PM Flag

    All true, except he hit the Peter Principle in the Illinois statehouse, where he voted "present" (like a coward) quite a large number of times. He wouldn't have advanced further in office had it not been for the media's unwillingness to vet him or criticize him. He won the Illinois Senate election only because judges immorally and unjustly unsealed embarrassing details about his opponents' divorce records, first in the primary contest and then in the general election -- two separate times! Dirty election tactics, affirmative action and white guilt among the electorate, and media collusion led to his ascendancy well beyond where the Peter Principle would have naturally left the former community agitator who won't let the world see his college transcripts. Anybody who voted for him is a dumb****. Anyone who still supports him is ****ed up beyond all hope or help.

  • Reply to

    Am Impressive Obama Accomplishment

    by j20tower20 May 1, 2016 11:15 AM
    whippersnapper65 whippersnapper65 May 1, 2016 4:39 PM Flag

    Yes, J20, I saw that report. The US economy would have been much stronger and recovered more quickly and robustly had Romney been president instead of BHO. Obama has the worst economic record of any US president (as well as the worst domestic policy and international relations records). That's no coincidence because Obama's policies are directly to blame for the tepid economic recovery. Obamabot libs will now start calling economic facts racist because the facts make BHO look bad. How dare anyone question or challenge Dear Leader! We knew it was a huge error to elect an inexperienced, Marxist, pseudo-intellectual, America-hating, Muslim-sympathizing, phony-Christian, affirmative action man as president. Too bad there are so many drones in this country who can't think rationally because they've been infected by the mental disorder called liberalism.

  • Reply to

    Am Impressive Obama Accomplishment

    by j20tower20 May 1, 2016 11:15 AM
    whippersnapper65 whippersnapper65 May 1, 2016 3:57 PM Flag

    Obamabots are #$%$.

  • whippersnapper65 whippersnapper65 Apr 29, 2016 11:53 PM Flag

    Hint: it's also not called "Glembat".

    Motley fool indeed.

    Sentiment: Strong Buy

  • Celldex keeps posting new jobs. These two appeared yesterday and today. They are low-level support positions.

    1) Associate Scientist

    The Associate Scientist will be part of a team developing purification processes for recombinant antibodies and recombinant proteins.

    Primary responsibilities include supporting the development of purification processes, maintaining stability studies, sample and data management, and supporting the process technology transfer to our manufacturing facility, including execution of viral clearance studies.

    2) Associate Scientist, Analytical Development

    The Associate Scientist - Analytical Development (AD) will be responsible for providing analytical support to Quality Control (QC). This includes, but is not limited to, the following: development of new analytical methods for QC, overseeing transfer of new methods from AD and Research & Development to QC; troubleshooting problems with existing QC methods; qualification of new reference standards, controls, and critical reagents; biochemical characterization testing of cGMP and developmental product manufactured by Celldex Biomanufacturing Operations, as well as drafting Technical Reports for all development, qualification and characterization analyses performed.

    Under the guidance of the AD Supervisor, conduct various independent laboratory experiments to satisfy the overall AD objectives of development and/or troubleshooting of assays for Quality Control.
    Assist with the hands-on execution of approved experimental protocols.
    Generate supplies of critical reagents, standards, and controls and conduct the necessary qualification as per the governing critical reagent qualification Standard Operating Procedure (SOP).
    Author, or assist in authoring, SOPs, technical reports, qualification reports and transfer study reports based on the results of laboratory experiments.
    Assist with the ordering and receipt of reagents, equipment...

    Sentiment: Strong Buy

  • Reply to

    The #$%$'s Riot

    by francogarabaldi Apr 29, 2016 9:07 AM
    whippersnapper65 whippersnapper65 Apr 29, 2016 12:53 PM Flag

    Riots and intolerance and tyranny and economic stagnation and dangerously uncontrolled immigration and racial balkanization and persecution of authentic people of religious faith are the result of leftism in America. You want to see the future of America under continued leftist rule? Look at the riots in Costa Mesa. Leftism is suicide for Western civilization and destructive of high-character, high-class, high-ideals, high-achievement, high-morality and high-hopes among human beings. Nobody with any wisdom is on the left. Nobody.

  • whippersnapper65 whippersnapper65 Apr 27, 2016 5:59 PM Flag

    Thank you, btchinvstr. I agree the statement about "pre BLA approval" work wasn't necessary in the job description; therefore it could be an encouraging bread crumb that management put out there for investors to notice while the company is prohibited from releasing material information.

    I don't know why my post got so much hate in the form of an inordinately large number of red thumbs from people who can't draw reasonable inferences from such an odd job posting and description. Maybe they simply hate the company or hate me. Haters gonna hate, hate, hate, hate, hate but I'm just gonna shake, shake, shake, shake, shake... shake it off.

    The job posting is most peculiar.

    All of your hypotheses are plausible. Thanks for sharing those.

    Sentiment: Strong Buy

  • This is puzzling: a six-month, part-time temporary hire for quality assurance? To assist with scanning and filing activities associated with pre BLA approval? What could this be for? Very peculiar. Is something brewing related to Rintega that the company has not made public?

    Job just posted today:



    Great opportunity for someone with solid administrative skills to get experience/exposure to Pharma/Biotech!
    This position would assist with additional QA documentation, scanning and filing activities associated with pre BLA approval. Additionally, this role will support implementation of scanning and electronic documentation, oversee internal/external documentation storage and help with overall Quality System support.
    20-30 hours/week (M-F only, no evenings or weekends), 6 months +/-


    General QA GMP documentation/filing/reconciliation activities to support manufacturing, validation, facilities and QC
    Scanning and maintaining electronic copy executed BRs
    Document issuance/reconciliation and distribution
    Oversee document filing in Fall River
    Assist in creation and issuance of labels
    Use of computer for document uploading and tracking
    May also be involved in general compliance functions including training, quality systems number assignment and SOP review


    Excellent written and verbal communications skills
    Must be able to lift and stack small boxes as needed, approx. 20-30 lbs. each
    Demonstrable skill in full MS Office Suite
    Must be able to work independently and in team situations
    Experience and/or exposure to GMP quality systems, policies and regulations preferred

    BA/BS in Life Sciences preferred, or pursuing BA/BS in Life Sciences
    Experience working with Iron Mountain Records and/or Data Management preferred
    Minimum of 1-2 years GMP experience preferable, or office experience related to health care, bio tech, pharma, life sciences or other medically-related environments

    Sentiment: Strong Buy

  • Reply to

    rumble, give it a rest already

    by cyoung8404 Apr 26, 2016 7:59 AM
    whippersnapper65 whippersnapper65 Apr 27, 2016 2:17 PM Flag

    "Stupid" certainly is an apt descriptor for the message board bonehead. It's still red-thumbing posts by people who ignore it. It still replies to messages posted by people who ignore it. Definitely stupid. It will probably reply to this post because it can't stop itself from trying to be relevant and begging for validation. It's is definitely stupid, but its envy and feelings of inadequacy and inferiority are even greater, which impel it to do all the things I stated above. Stupid, envious, inadequate and inferior: that's mbb in a nutshell.

  • whippersnapper65 whippersnapper65 Apr 27, 2016 1:20 PM Flag

    The company probably already has several statisticians. Celldex now has many, many more trials in progress than was the case previously, so it would seem that an additional statistician is needed to handle the increased need for statistical analysis of trials.

    Sentiment: Strong Buy

  • New on the Careers page on the company website:

    NJBIZ Best Places to Work
    Celldex Therapeutics was named a Best Places to Work for 2016, NJBIZ's annual list of the 100 best employers in New Jersey. Rankings were based on eight core focus areas: leadership and planning; corporate culture and communications; role satisfaction; work environment; relationship with supervisor; training, development and resources; pay and benefits; and overall engagement

    Sentiment: Strong Buy

  • Posted today


    Celldex Therapeutics seeks an experienced biostatistician to join our company as Associate Director, Statistician to support oncology drug development. This position will be based in either Needham, MA or Hampton, NJ.

    •Provide statistical expertise in design, analysis, and clinical report for phase I, II, III oncology clinical trials.
    •Represent the biostatistics function in the clinical development team and interact with other function team members.
    •Perform sample size calculation for continuous, dichotomous, and time to event endpoints in various study designs.
    •Write the statistical section in protocol and prepare the statistical analysis plan (SAP).
    •Lead internal biostatistics and programing team and provide statistical inputs to support the clinical study report for multiple clinical trials including planning, supervising, validating, and reviewing the statistical deliverables.
    •Perform simulation studies to explore the statistical operating characteristics in study design phase including innovative/adaptive designs.
    •Perform consistent statistical analyses to support publications in medical conferences.
    •Review protocol, CRF, IVRS Specs, SAP, SDTM Specs, ADaM Specs, CSR, conference presentation, manuscript for publication, and other statistical documents.
    •Participate in BLA/NDA submission activities as a key stat team member.
    •Oversee and manage CRO statistical and programming activities

    •Completed PhD in Statistics or related field required.
    •6 or more years of biopharmaceutical experience as a lead statistician required.
    •2 or more years of oncology experience preferred.
    •Experience/Knowledge with adaptive/innovative study designs preferred.
    •Experience with drug development in biologics and targeted therapies preferred.
    •Experience with regulatory submissions to support integrated summary of Safety (ISS) / Efficacy (ISE) preferred.

    Sentiment: Strong Buy

  • Reply to

    A Year From Now

    by remingtonredneck72 Apr 25, 2016 4:03 PM
    whippersnapper65 whippersnapper65 Apr 25, 2016 10:13 PM Flag

    That's why I'm still holding. Had ACT IV gone the other way, which it easily could have (no one predicted the control arm would outperform historical precedents because there was no reason to expect that) then CLDX would be trading at around $30 per share right now. A highly improbable (and highly suspect) fluke in the control arm is the reason CLDX isn't above $20 right now.

    If the METRIC trial for Glemba succeeds, CLDX will trade over $40 easily on that success and on the expectation that Glemba will also succeed in other cancers with high gpNMB.

    Varli success takes the share price over $100, easily.

    The failure of ACT IV was a temporary setback resulting in a delay in reaching commercialization and high valuations, not the death of the company.

    Sure would be nice to see directors and executives buy shares at this price.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Apr 22, 2016 7:00 PM Flag

    Looks like you're going on ignore, greenunderwood. I told you that TA doesn't work on CLDX, and I'm tired of your ramblings and self-corrections cluttering the message board. Good-bye: you've been placed on ignore.

    Sentiment: Strong Buy