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whippersnapper65 1333 posts  |  Last Activity: Jan 29, 2015 8:31 PM Member since: Jun 20, 2009
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  • Reply to

    briston myers - why is it such a

    by rxkell Jan 29, 2015 9:57 AM
    whippersnapper65 whippersnapper65 Jan 29, 2015 8:31 PM Flag

    Wow! I just checked the after-hours quote and news for ICPT. Shows you what will happen to CLDX when it receives breakthrough designation or commercial approval for Rintega.

    Makes you wonder why breakthrough designation hasn't been granted already, but it's not necessary for early approval. The excellent data are sufficient for that.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 29, 2015 3:31 PM Flag

    Manipulation by IOs. If you're new to the stock, get used to it. The IOs want to own as many shares as they can without driving up the price. How do you think Blackrock managed to acquire that many more shares without causing the price to jump to the $30s overnight? They sell/buy/sell/buy/sell/buy and gradually they increase their holdings without running the price up much because they manage to trick retail holders into parting with their shares by triggering stop losses or scaring them with the volatility and sharp pullbacks.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 29, 2015 2:47 PM Flag

    Yeah, they doubled their total holdings in CLDX. Very bullish sign. IO has to be over 95% now.

    Sentiment: Strong Buy

  • IOs want 99% of Celldex shares.

    Sentiment: Strong Buy

  • Reply to

    briston myers - why is it such a

    by rxkell Jan 29, 2015 9:57 AM
    whippersnapper65 whippersnapper65 Jan 29, 2015 1:26 PM Flag

    Varli has already demonstrated promising efficacy and safety as a monotherapy, notably a complete response in a Hodgkin lymphoma patient who had a death sentence because she had failed every prior therapy; varli was literally her last chance at life, and varli gave it to her! The biological mechanism of action for varli is well understood. The reason for the phase 1/2 combo trial is because it's the first trial of varli in combo with nivo, so proper dosages have to be determined (phase 1) before advancing to significant proof-of-concept (phase 2); then the large, statistically significant pivotal study (phase 3) can be conducted. However, if the combo demonstrates robust efficacy it is possible that the FDA could approve the combo of varli and nivo on the basis of phase 2 data. Nivo has already received accelerate approval on the basis of efficacy in a patient population with severe unmet need.

    Sentiment: Strong Buy

  • But Varli has had no history of adverse effects on patients to date.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 29, 2015 10:31 AM Flag

    After all this time I should be used to the manipulation of CLDX, but it never ceases to annoy me. This stock ought to be trading in the mid-$30s minimum. Every good news release is used as an opportunity for manipulation rather than solid gains in market cap. The shorts seem to have an endless supply of shares available to sell.

    Sentiment: Strong Buy

  • Reply to

    Celldex now listing 22 open jobs

    by whippersnapper65 Jan 28, 2015 3:48 PM
    whippersnapper65 whippersnapper65 Jan 28, 2015 9:29 PM Flag

    Furthermore, Celldex is a fairly small company, having only about 130 employees. So to hire 22 more is a significant expansion of the total personnel.

    Sentiment: Strong Buy

  • The trials are now recruiting, so why hasn't the company publicized that development?

    Sentiment: Strong Buy

  • whippersnapper65 by whippersnapper65 Jan 28, 2015 3:48 PM Flag

    A new one today is: Director, Biopharmaceutical Process Development (Hampton, NJ or Needham, MA). Note how the job description mentions being responsible for "process scale up/optimization... for late state clinical development and subsequent commercialization of new biopharmaceutical products." Celldex is ramping up for commercialization.

    Job Description:

    This position will be responsible for managing drug substance and sterile drug product contract manufacturing operations, including tech transfer, process scale up/optimization, and process validation for late stage clinical development and subsequent commercialization of new biopharmaceutical products. This role requires a strong scientific background, strong project management skills, experience working with/for contract manufacturing organizations (CMOs), and demonstrated ability to develop biopharmaceuticals for clinical and commercial use. Strong interpersonal and communication skills are required.

    Sentiment: Strong Buy

  • If you want to keep your CLDX shares, don't place a trailing stop order.

    IOs want as many of your shares as they can shake loose.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 27, 2015 7:43 PM Flag

    Oh, and the cup and handle formation is complete and showing signs of an imminent breakout higher. That will attract the attention and buying interest of technical traders and momentum traders.

    Sentiment: Strong Buy

  • Apple's strong earnings should assist the market in rebounding tomorrow from today's selloff.

    Additionally, as another poster observed, the Varli/Nivo combination trials are now listed as recruiting on the clinical trials website. There ought to be a press release announcing that fact before market open tomorrow.

    A rebounding market with a press release about a potentially effective and lucrative combination immunotherapy treatment ought to give CLDX shares strong support, perhaps enough to run up to $25 and test that level.

    Combine all the above with the news today about the short interest in CLDX increasing to 20 million shares, and there is the potential for a mini short squeeze if CLDX is able to breach $25 and convince shorts to begin covering their losing positions.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 27, 2015 7:14 PM Flag

    I was a MEDX shareholder at the time of the buyout orchestrated by Howard Pien. Although I made a handsome return on that investment, I believe the company was sold too soon and for too little: shareholders could have gained five times as much as they received from the buyout had Medarex remained independent through FDA approval of Ipilimumab.

    I hope Celldex's management doesn't make the same error that Howard Pien made by selling the company too soon and for too little. Although Celldex was a spinoff of Medarex, the progeny has grown to be bigger than the parent: Celldex's assets are far more valuable than anything Medarex had.

    If there hasn't been a buyout already, it seems that Marucci intends to keep Celldex independent at least through FDA approval of Rindo. Waiting for FDA approval of Glemba and phase-2 results from Varli before making any buyout deal would probably maximize value for shareholders.

    Sentiment: Strong Buy

  • Reply to

    Varli + Opdivo trial now open for recruitment.

    by ski8688 Jan 27, 2015 5:17 PM
    whippersnapper65 whippersnapper65 Jan 27, 2015 6:04 PM Flag

    Maybe there will be a press release announcing that development on Wednesday morning.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Jan 26, 2015 2:53 AM Flag

    If Varli (1127) proves effective in phase 2 clinical trials then CLDX ought to trade at ten times the current valuation.

    When the market realizes that then the share price will be close to $80.

    Sentiment: Strong Buy

  • Reply to

    Technicals look amazing to say the least....

    by wiszad Jan 23, 2015 8:29 PM
    whippersnapper65 whippersnapper65 Jan 24, 2015 3:58 AM Flag

    The weekly chart looks even better!

    Sentiment: Strong Buy

  • Another job opening that demonstrates Celldex is preparing for many regulatory filings ahead, including NDA and BLA submissions:

    Education/Experience:
    •Must have 5-10 or more years of experience as a medical writer preparing clinical regulatory submission documents.
    •Experience in medical writing project leadership roles for complex submissions, preferably within the field of oncology.
    •Completed BA/BS degree is required, with a concentration in a scientific or health care field preferred.
    •Later phase writing experience (e.g., Phase 3) and BLA/NDA experience in oncology are strongly preferred.

    Sentiment: Strong Buy

  • One among thousands of reasons to be frightened by the prospect of a Warren presidency: she would spearhead a populist shakedown of pharma and biotech companies.

    From CNS News:

    Sen. Elizabeth Warren (D-Mass.) touted increasing spending in public medical research at a Families USA Health Action Conference at the Hyatt hotel in Washington, D.C., on Thursday telling drug companies you “did not do it alone” and “we built those medical innovations together.”

    “We celebrate the accomplishments of our pharmaceutical industry because these blockbuster drugs let people live longer, healthier lives,” Warren said. “But we are also mindful that these drug companies did not do it alone.

    “Many drugs have generated billion-dollar profits and are used by millions of consumers that don’t just appear overnight,” Warren said. “Rarely do they appear as a result of a single giant company’s individual genius.

    “Drug companies make great contributions, but so do taxpayers,” Warren said. “In other words, we built those medical innovations together.”

  • whippersnapper65 by whippersnapper65 Jan 22, 2015 7:14 PM Flag

    Celldex is growing and expanding, and new positions continue to be added. Management must be confident that there will be ample revenue to justify the additional personnel and operational costs associated with ramping up (commercial) production and increasing clinical investigations of treatments deep in the pipeline.

    Management is conducting business as if early approval of Rindo is a fait accompli.

    Sentiment: Strong Buy

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