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Celldex Therapeutics, Inc. Message Board

richrd_cc 36 posts  |  Last Activity: Aug 25, 2014 11:16 PM Member since: Jan 30, 2003
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  • Reply to

    SNTA Risk / Reward

    by cadillacofminivans Aug 25, 2014 7:33 PM
    richrd_cc richrd_cc Aug 25, 2014 11:16 PM Flag

    As to your first question....the only reason that early FDA approval is possible is because of the fact that NSCLC has an unmet medical need. The degree of the possibility is not known...it all lies on the progress of patients in the trial. If ongoing treatments meet FDA thresholds for meeting the unmet need then early approval happens. So, if threshold is not met then the drug may not be approved at all or the drug may be approved after the conclusion of the trial.

    Thought # 1 - In recent months/years, SNTA has had a very high short percentage of float. The past high short percentage of float could be due to true investor sentiment on the expectations of negative performance but in the next year short manipulation is to be expected because of the past success of short positions. Throughout the next year short manipulation is to be expected because of the past success of short investing SNTA. This is a natural phenomenon of stocks in this particular phase of growth.

    Thought # 2 - It seems that the board of directors have always focused on bringing ganetespib to market. Past decisions and actions have been fine tuned and the hiring of Anne Whitaker was the culmination of the best thought out plan to date. The thoughts of a successful launch of ganetspib in the marketplace became thoughts of launching the product globally....hiring Anne Whitaker brings the thoughts and plans of the board close to becoming reality.

    Sentiment: Strong Buy

  • Reply to

    SNTA Risk / Reward

    by cadillacofminivans Aug 25, 2014 7:33 PM
    richrd_cc richrd_cc Aug 25, 2014 9:24 PM Flag

    The list of potential announcements (hopefully good news announcements) in 2015 are numerous. The stock price has consolidated and continues to consolidate around the $4 per share area. The slow methodical growth of the stock price may begin at any time from here going into 2015 and beyond. As the price grows the shorts will try to hold it down but the frequent news events will put a squelch on short activity overall.

    There is a potential for unexpected good news because of the fact that the FDA granted fast track designation of ganetespib in non-small cell lung cancer. News could come out on the early FDA approval for this indication if the existing trial has good outcome results for a significant percentage of patients. An early FDA approval announcement would catch shorts in a huge covering mode which could propel the stock much higher.

    Near term unexpected announcements could include partnership agreements for global marketing of ganetespib. Anne Whitaker has a great background in the commercialization of new drug products and will more than likely develop a strategy for taking ganetespib to markets worldwide. Involving a partner prior to FDA approval would be a smart move so that once approval is granted....the product takes off running. A high caliber CEO like Ms. Whitaker may prove to be one of the best moves that Synta has ever made.

    Other potential unexpected announcements could include the commencement of clinical trials with HDC platform drug products. Being that the payload drug products that are being linked to the heat shock protein inhibitor moiety are already FDQ approved for the treatment of various cancers it may not be difficult to get the clinical trials started.

    The upcoming period for Synta is very interesting and investors know that there are many possibilities that could push the stock price much higher. I would not be surprised to see the stock price somewhere between $10 and $20 within the next year

    Sentiment: Strong Buy

  • Reply to

    Continued timeline

    by richrd_cc Aug 20, 2014 10:10 AM
    richrd_cc richrd_cc Aug 20, 2014 11:55 AM Flag

    Thanks...I forgot to go back and include that in the timeline.

    Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
    Estimated Completion Date January 2016

    Sentiment: Strong Buy

  • richrd_cc by richrd_cc Aug 20, 2014 10:10 AM Flag

    A Trial of Ganetespib Plus Sirolimus: Phase 1 Includes Multiple Sarcoma Subtypes and Phase 2 MPNST
    Estimated Completion Date Dec-17

    Note: The Estimated Completeion date may either be the actual estimated completion or the Estimated
    Primary Completion Date

    Sentiment: Strong Buy

  • An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer (Enchant) Estimated Completion Date Dec-14
    Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
    Estimated Completion Date Feb-15
    Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
    Estimated Completion Date A pr-15
    A Phase I Study of Ganetespib +/- Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma
    Estimated Completion Date Sep-15
    Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer
    Estimated Completion Date Nov-15
    Ganetespib With Pemetrexed-cisplatin, in Patients With Malignant Pleural Mesothelioma (MESO-02)
    Estimated Completion Date Dec-15
    A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC (Galaxy 2) Estimated Completion Date Mar-16
    Paclitaxel and Ganetespib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Estimated Completion Date Sep-16
    Ganetespib, Paclitaxel and Trastuzumab for Advanced or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Estimated Completion Date Sep-16
    (continued)

    Sentiment: Strong Buy

  • Reply to

    Sanofi to buy Synta Pharmaceutical

    by jcal4uhealth Aug 18, 2014 11:20 AM
    richrd_cc richrd_cc Aug 18, 2014 4:19 PM Flag

    Agreed....the OP has it all backwards.
    Synta Pharmaceutical to buy SANOFI should be the title....grin.

    Sentiment: Strong Buy

  • Reply to

    HDC Platform and Partnerships

    by richrd_cc Aug 12, 2014 12:03 PM
    richrd_cc richrd_cc Aug 16, 2014 11:01 AM Flag

    Yes...agreed. My point is that once the ball starts rolling...it could snowball into huge gains.

    Sentiment: Strong Buy

  • The HDC platform doesn't seem to have any value yet in the eyes of the market. The large number of drug products that are being patented by SNTA should eventually hold huge value. Whenever a partnership or other deal with just one of the HDC platform drugs occurs, the value of SNTA will just skyrocket. One partnership with the potential for 400 others will open eyes of the analysts and move the share price of SNTA tremendously. Holding long in SNTA should one day prove to be a very lucrative move...it will take some time but when it happens...it will be phenomenal.

    Sentiment: Strong Buy

  • Let's not forget the Sept. 2013 news on ganetespib....
    FDA Grants Fast Track Designation for Ganetespib in Non-Small Cell Lung Adenocarcinoma

    Sentiment: Strong Buy

  • Reply to

    BIG Pic. thoughts:

    by ajetjock Aug 7, 2014 10:09 AM
    richrd_cc richrd_cc Aug 7, 2014 4:51 PM Flag

    It looks like the BOD is now focused on commercializing ganetespib and are gearing up to get the approval and then land a subsequent partnership to market the product around the World for various cancer treatments. This is all starting to make sense...it seems that Bernitz was probably released because it became apparent that it was way too premature to work on a meaningful, successful partnership at this particular point in time. The new goal of getting FDA approval and then seeking a mutual positive partnership to take the drug to market sounds like a great plan that will reap rewards for all of us shareholders. The hiring of Anne Whitaker is the perfect icing on the cake that will facilitate the successful implementation of the new plan. I am liking what I am seeing and hope that I can accumulate more before the price goes much higher.

    My two cents....

    Good Luck longs!

    Sentiment: Strong Buy

  • richrd_cc richrd_cc Aug 6, 2014 9:30 AM Flag

    SNTA appointed a Hall of Famer caliber CEO in Anne Whitaker. This is the best news that we could have received today. Good luck longs....

    Sentiment: Strong Buy

  • Reply to

    Expectations for the Call

    by cadillacofminivans Aug 4, 2014 2:50 PM
    richrd_cc richrd_cc Aug 4, 2014 3:22 PM Flag

    The leukemia study is investigator sponsored. I do not believe that SNTA is spending any money on this study.

    Sentiment: Strong Buy

  • Reply to

    SNTA

    by locke12 Aug 3, 2014 10:54 PM
    richrd_cc richrd_cc Aug 4, 2014 7:26 AM Flag

    SNTA valuation at this point in time is not an easy task. Continued positive outcomes with ganetespib in ongoing trials brings up the value of that product. The unknown value of the HDC platform is a key component to the true value of SNTA and these products could eventually make up most of the SNTA drug product pipeline. The science behind the HDC platform is sound and a number of great products will probably evolve from this platform over time. The current stock price does not put a value on the HDC platform drug products which is the hidden value in owning the stock. Over the next couple of years the values will become more apparent and the stock price should climb respectively. Assuming that SNTA only has buyout value is way off. This is a good long term play and the low price has been great for those accumulating shares.

    The key to investing in SNTA is .....Keep an eye on the HDC Platform!

    Sentiment: Strong Buy

  • Reply to

    Target Oncology Article on Ganetespib 8/1/14

    by richrd_cc Aug 2, 2014 12:09 PM
    richrd_cc richrd_cc Aug 2, 2014 1:24 PM Flag

    It's probably not going to rock the stock on Monday. But...the science behind ganetespib continues to look positive. There is the underlying potential that HSP90 inhibitors play a key role in a number of cancer types and ganetespib's safety profile is at the forefront of this class of drugs.

    Sentiment: Strong Buy

  • The following title can be found on PubMed....looks great

    The HSP90 inhibitor ganetespib potentiates the antitumor activity of EGFR tyrosine kinase inhibition in mutant and wild-type non-small cell lung cancer.

    Sentiment: Strong Buy

  • richrd_cc richrd_cc Aug 1, 2014 1:14 PM Flag

    Hopefully SNTA will provide details on the most recent news regarding ganetespib and we will see a nice boost in stock price. More importantly I hope that the details lead to an uptrend with feet.

    Sentiment: Strong Buy

  • richrd_cc richrd_cc Jul 25, 2014 8:19 PM Flag

    I agree with Apache here....the hedge funds optimize their income by milking dollars away from the average Joe. They optimize their income by making average Joe, long term investor Joe, cringe numerous times throughout the long hold. Those average Joe longs that are smart....may cringe a little when they work the stock price up and down to capture shares and profit but know that in the long run they will make some dollars. You have to have some big and strong nads to hang in the company of those invested in biotech. It's a tough sector in which to hang on for the ride...but eventually it can definitely pay off.

    Sentiment: Strong Buy

  • Reply to

    Phase III - Futility Analysis

    by richrd_cc Jul 23, 2014 10:11 AM
    richrd_cc richrd_cc Jul 23, 2014 3:38 PM Flag

    If you read the announcement...it is clear that details will be released as soon as they are formalized.

    Sentiment: Strong Buy

  • Reply to

    Phase III - Futility Analysis

    by richrd_cc Jul 23, 2014 10:11 AM
    richrd_cc richrd_cc Jul 23, 2014 3:37 PM Flag

    Yes, you're probably right...I'm sure that it may rarely occur that a company would keep a drug in trials if expectations are low. But mainly, I wanted to point out that futility can mean two things.

    In SNTA's case it sounds like the drug was pushed into Phase III with high expectations. Adding an interim futility analysis in this case is just drawing a picture for investors. This means to me that there is a good possibility that the trial will be halted early because of great results in order to push for quicker FDA approval or the trial may be altered so that all patients get ganetespib due to the high response rates in the ganetespib arm of the study. If either of these scenarios turn out to be the case....we could see SNTA move much higher.

    Sentiment: Strong Buy

  • Another big piece in the news release yesterday was that the Phase III study will include an interim futility analysis. Futility analyses are usually used to evaluate one of two things:

    1. Has the product continued with extraordinary positive performance. This is performed with hopes of stopping the trial early to advance approval.
    2. Is the product performing as poor as expected based upon Phase II results. This futility analysis is added with low expectations with intentions of terminating the trial.

    Ganetespib was depicted as having very positive results in Phase II and was moved into Phase III. The news indicates to me that this interim futility analysis is for the former reason.

    Sentiment: Strong Buy

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