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whippersnapper65 408 posts  |  Last Activity: 20 hours ago Member since: Jun 20, 2009
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  • Listed, but not yet recruiting. Shows October 17 as the most recent update. This trial is part of the collaboration agreement with Oncothyreon, the first of several new Varli trials to begin this quarter.

    Detailed Description:

    This is a two-part Phase 1b, open-label study of ONT 10 administered in combination with varlilumab. Two different doses of varlilumab will be studied in combination with the single agent recommended dose of ONT 10. Intermediate and/or lower doses of varlilumab or ONT-10 may also be studied at the recommendation of the safety monitoring committee (SMC). Treatment will be administered in cycles of 12 weeks each. All patients will receive a single dose of cyclophosphamide on Day -3. During Cycle 1, patients will receive ONT-10 administered SC once per week for 8 weeks followed by ONT-10 once every 6 weeks starting with Cycle 2, in combination with varlilumab administered IV once every 3 weeks x 3 doses, and then once every 6 weeks for cycles 2 through 5.

    Each cohort will enroll an initial group of 6 evaluable patients with either breast or ovarian carcinoma. Initial enrollment into a cohort will be staggered, with the first patient treated in any new cohort to be followed for a minimum of two weeks for the occurrence of Unacceptable Toxicity prior to enrollment of the remaining 5 patients. Subsequent enrollment into a cohort may then continue without a staggered schedule until 6 patients treated are considered evaluable. Up to 24 additional evaluable patients may be enrolled and treated in Part 2 at the RD of varlilumab and ONT-10 identified in Part 1, including approximately equal numbers of patients with breast carcinoma (n~12) and ovarian carcinoma (n~12). Treatment in Part 2 will follow the same schedule as in Part 1.

    Sentiment: Strong Buy

  • I believe this is voter fraud, not an error. Liberals are corrupt. How much voter fraud goes undetected? How many liberal officials are serving fraudulently?

    Admitting his confidence in Cook County ballot integrity is shaken, State Representative Candidate Jim Moynihan (R-56), was shocked today when he tried to cast a vote for himself and the voting machine cast it for his opponent instead.

    “While early voting at the Schaumburg Public Library today, I tried to cast a vote for myself and instead it cast the vote for my opponent,” said Moynihan. “You could imagine my surprise as the same thing happened with a number of races when I tried to vote for a Republican and the machine registered a vote for a Democrat.”

    While using a touch screen voting machine in Schaumburg, Moynihan voted for several races on the ballot, only to find that whenever he voted for a Republican candidate, the machine registered the vote for a Democrat in the same race. He notified the election judge at his polling place and demonstrated that it continued to cast a vote for the opposing candidate’s party. Moynihan was eventually allowed to vote for Republican candidates, including his own race. It is unknown if the machine in question (#008958) has been removed from service or is still in operation.

  • whippersnapper65 whippersnapper65 Oct 21, 2014 7:52 AM Flag

    BIOSYN wanting to be paid in CLDX stock is akin to the artist who painted the mural at Facebook's headquarters wanting to be paid in Facebook stock. That guy is a multi-multi millionaire now because he took payment in the form of a potentially highly appreciating asset rather than cash. BIOSYN saw a similar opportunity.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Oct 21, 2014 1:31 AM Flag

    And don't forget this:

    "BIOSYN will support all regulatory filings of Celldex and allow Celldex to cross-reference Biosyn’s Drug Master File for KLH as required by U.S. and foreign equivalent agencies."

    Why enter into such a long-term agreement now that includes BIOSYN's support for Celldex's regulatory filings if commercialization isn't expected until 2016 or 2017? What's the rush?

    Marucci is lining up the ducks for submitting for early approval for Rindo in 2015, based on outstanding ReACT data and possibly an early stop in ACT IV.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Oct 20, 2014 7:50 PM Flag

    Excellent ReACT data would rapidly and staggeringly change the entire valuation equation because of the following:

    1) Rindo works: very likely approval of Rindo by 2016, perhaps early approval in 2015 based on ReACT
    2) Revenue from Rindo
    3) About 20 million short shares need to cover
    4) 92% institutional ownership ready to hold on tight for tremendous gains in the hottest biotech of 2015-2016
    5) Buyout speculation

    That's not even factoring Glemba or Varli into account.

    Sentiment: Strong Buy

  • They will learn that for every action there is an equal and opposite ReACTion, and they will feel it in their behinds as CLDX makes new highs this year.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Oct 20, 2014 5:30 PM Flag

    If both ACT IV and METRIC are stopped early for efficacy in 2015, then I would expect CLDX to trade over $100 per share by the end of 2015. However, that is a best-case scenario. A more likely scenario is hitting that mark by the 1Q of 2017, if both Rindo and Glemba have been commercialized by the end of 2016.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Oct 20, 2014 4:19 PM Flag

    I am not hedged; long-term holder/investor. Have utmost confidence in Celldex's science and ability to succeed.

    If Marucci doesn't deliver with highly impressive Rindo ReACT results in November, if all his optimistic talk has been bluster, then I will begin to doubt Marucci and Celldex, as I have stated before. For now, I don't have good enough reasons to hedge.

    Marucci has talked and promised and hinted and indicated that Rindo will be commercialized. He must have some strong basis, otherwise he will turn out to have been a charlatan. I believe his strong basis is his knowledge of the ReACT results.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Oct 20, 2014 4:10 PM Flag

    No, you misunderstand and obfuscate, probably because you're biased to the short side and filter anything through that bias.

    Do not forget that Celldex negotiated a reduction in future royalties that Celldex would owe BMS (via Medarex) based on future Varli revenue. If Varli is a blockbuster, that decision could make a $150 million upfront payment look like chump change.

    The BMS collaboration agreement will give BMS privileged, direct access to the phase 2 Varli/Nivo combination trial data before it is revealed to the public. BMS will have an edge over any other pharmaceutical company with regard to Celldex's Varli both because it will have privileged access to the data and because it has right of first refusal regarding Varli/anti PD-1 partnering.

    You can bet your butt that if the phase-2 data are compelling BMS will move to acquire Celldex. By that time, with Rindo and Glemba commercialized and some public knowledge of Varli phase-2 data, CLDX will be trading in excess of $100 per share.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Oct 20, 2014 3:39 PM Flag

    Knowledge of the results of this study increases the confidence that ACT IV will succeed. This study shows that GBM patients with self-generated anti-EGFRviii antibodies survive longer than patients who lack the antibodies. Rindo induces an immune response against EFGRviii tumors and cells, and patients with high antibody titers after treatment with Rindo have demonstrated the most robust immune responses. In other words, this study, although not directly related to Rindo or Celldex, shows that the biological mechanism of action upon which Rindo is based leads to increased survival in EGFRviii GBM patients.

    Sentiment: Strong Buy

  • Reply to

    **UPDATE*** BIOSYN Corporation and CLDX

    by k.baker60 Oct 20, 2014 9:17 AM
    whippersnapper65 whippersnapper65 Oct 20, 2014 3:24 PM Flag

    I thought the same thing.

    Sentiment: Strong Buy

  • Reply to

    CLDX at Morgan Stanley: notes:

    by long_vrts2 Sep 9, 2014 1:57 AM
    whippersnapper65 whippersnapper65 Oct 19, 2014 10:53 PM Flag

    The short position has very little in its favor; all evidence points to the probability that Celldex will succeed in getting Rindo commercialized.

    When that probability becomes a certain reality, the short position will be vaporized and CLDX will trade 100%-200% higher than its current valuation.

    Sentiment: Strong Buy

  • Reply to

    SABC meeting in December...

    by frankfrazzano Oct 17, 2014 1:00 PM
    whippersnapper65 whippersnapper65 Oct 18, 2014 12:35 PM Flag

    Yes, those facts may be verified on the website. However, the PDF file that began the conversation did not corroborate those facts. The person who pointed out that the PDF file listed Celldex as a 2013 exhibitor rather than a 2014 exhibitor was correct. Now I believe the full picture is revealed for everyone to see.

    Sentiment: Strong Buy

  • Reply to

    SABC meeting in December...

    by frankfrazzano Oct 17, 2014 1:00 PM
    whippersnapper65 whippersnapper65 Oct 18, 2014 12:31 PM Flag

    Frank, I haven't read an announcement that the Varli/Nivo combination trials have begun. The collaboration announcement stated that the trials would commence in the fourth quarter.

    Agree with you about ducks lining up nicely for Celldex. The next 12-24 months will be transformational for the company and lucrative for longs.

    Sentiment: Strong Buy

  • Reply to

    How Realistic

    by mjacob56 Oct 17, 2014 7:51 PM
    whippersnapper65 whippersnapper65 Oct 17, 2014 9:10 PM Flag

    If Varli works as a monotherapy as well as in combination with many other approved cancer treatments to boost their efficacy, then your valuation is attainable. But not sooner than in three years.

    Sentiment: Strong Buy

  • Reply to

    SABC meeting in December...

    by frankfrazzano Oct 17, 2014 1:00 PM
    whippersnapper65 whippersnapper65 Oct 17, 2014 3:30 PM Flag

    No, ffmoo is correct: the pdf file that Frank shared is the registration and information booklet for the 2014 conference in December, but the page on which Celldex is mentioned as an exhibitor is a list of those who exhibited at last year's meeting. The pdf file does not provide any information about who is exhibiting at the 2014 meeting.

  • whippersnapper65 whippersnapper65 Oct 17, 2014 2:36 PM Flag

    I have been of the opinion for some time that in the age of the internet, saving data releases for major medical meetings is an obsolete practice.

    Sentiment: Strong Buy

  • Reply to

    SABC meeting in December...

    by frankfrazzano Oct 17, 2014 1:00 PM
    whippersnapper65 whippersnapper65 Oct 17, 2014 1:53 PM Flag

    An interim analysis in the METRIC (Glemba accelerated approval) trial is supposed to occur after the first 80 patients. When will that be? Enrollment has been active for ten months now. Chance of an early stop of the trial for efficacy in early 2015?

    Sentiment: Strong Buy

  • That was the case last year. So far no word about this year.

    A pre-announced and pre-scheduled CC coinciding with a data presentation at a medical meeting has usually indicated positive results in the data.

    Last year Celldex announced on October 21 that it would host a conference call on November 25 about the presentation of ReACT data at the SNO meeting, but that press release also announced a conference call about the presentation of Varli data at an earlier meeting on November 7.

    Given that the two Rindo presentations scheduled for SNO will only last ten minutes each, a conference call to explain good data in more detail and to update investors about the data's implications for Rindo development and commercialization would seem to be warranted.

    So, perhaps look for a press release about two-and-a-half weeks prior to SNO, which would be during the last week of October.

    If Celldex were not to host a conference call to discuss the data, I would take that as a negative indicator; but I am not expecting negative data.

    Sentiment: Strong Buy

  • Reply to

    accomulating at sub 15.5

    by raya_q8 Oct 17, 2014 10:00 AM
    whippersnapper65 whippersnapper65 Oct 17, 2014 10:54 AM Flag

    Says the guy who was "happy" that he "finally did something right" last week when he sold "half his shares" at 13.

    I told you you'd chase the share price buying them back soon. Funny to watch that be confirmed.

    Now today you said that you "bought back a bunch of shares in the $13 range" (probably closer to $14 than $13, if I had to bet) but omitted other relevant facts, which I supplied above.

    lol

    Sentiment: Strong Buy

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