I think your point is well taken. As far as I am concerned, most of these messages are thoughtful, interesting and helpful, but some are devious. I am retired, as I assume most on your list are, and appreciate the social interaction. I own 19,000 shares of Geron with an average price of ~$2.80, so my head is above water. My gut feeling and conjecture is that the FDA, with new pressure from JNJ/Janssen, will come through for us with some type of enhanced approval. I think this will happen in January or February, but, obviously, I have no special knowledge. I do believe that Imetelstat is a "remarkable" drug, and all that we have heard at the recent health conferences (Stifel, Piper-Jaffray, ASH) has been true and extremely promising for the future. After all, an investment is about the future.
Where have you been? MF is being treated successfully at Mayo Clinic, and that has been going on for a few years (CR, PR, CI, ORR). What else is needed for breakthrough or fast track approvals? "Tantamount to a Cure", has been shouted from the roof tops, and on this board.
MILPITAS, Calif. and FRANKFURT, Germany – Dec. 9, 2014 – FireEye, Inc. (NASDAQ: FEYE), the leader in stopping today’s advanced cyber attacks, and T-Systems, the business customer arm of Deutsche Telekom, today announced a partnership to deliver a security as a service offering that will bring a new level of protection to organizations in Europe. FireEye and T-Systems will work together to offer a comprehensive managed security service that counters IT espionage and advanced cyber attacks faster and more effectively.
The partnership combines T-Systems’ extensive managed service presence in the region with FireEye’s cyber defense expertise to make this advanced security capability available to organizations across Europe.
“In a study produced by FireEye, it found that when responding to breaches companies had been compromised for a median of 229 days, and with this partnership, T-Systems is taking steps to reduce response time to minutes for our customers in Europe,” said Reinhard Clemens, member of the Deutsche Telekom board of management and CEO of T-Systems. “Working with FireEye, T-Systems will not only be able to provide these organizations with an alert, but also detect the relevance and initiate targeted countermeasures.”
“Our partnership with T-Systems extends FireEye’s mission to deliver a new and more effective Adaptive Defense security model to organizations throughout Europe, protecting against advanced cyber threats with a truly unique combination of security technology, intelligence and expertise,” said Steve Pataky, vice president of worldwide channels and alliances at FireEye. “Together with T-Systems, FireEye is able to offer a broader base of organizations a security as a service offering that moves beyond the legacy defense models unable to solve today’s increasingly sophisticated cyber attacks in Europe and in regions worldwide.”
It is hard to know what is holding the PPS back at this point in time, with a relationship with JNJ, and the MF, MDS, and AML successes in humans and animals. FDA approval certainly would be a further endorsement. All the evidence seems to point to that endorsement coming very soon, and I thought ASH (2014) would be the trigger. We will see want January 2015 brings.
There is nothing that can stop IMET. The Geron-Mayo Clinic-JNJ/Janssen joint venture is financially very strong, plus scientifically and medically they are the best in the world.
Check Point Software has a market cap of about $15B, Palo Alto about $10B, and FireEye about $5B. I own them all, but FEYE appears to be the best investment at this point in time.
FDA approval (coming soon for IMET, a "remarkable medicine"), in itself, does not guarantee success. Yet FDA approval, which could come in the form of breakthrough therapy or fast track, coupled with the 10 items below, makes GERN a very good investment.
Of course, IMET has a lot going for it: 1. board based cancer applications, 2. JNJ/Jannsen, 3. Mayo Clinic, 4. Combination drugs, 5. Stifel and ASH health conferences, 6. no negatives, 7. patients needs, 8. unique remissions, 9. end of tax loss selling, 10. better public relations.
I was not trying to compare the biology of Provenge (PRO) and Imetelstat (IMET), but the fact that PRO has FDA approval and IMET does not. FDA approval (coming soon for IMET, a "remarkable medicine"), in itself, does not guarantee success. Of course, IMET has a lot going for it: 1. board based cancer applications, 2. JNJ/Jannsen, 3. Mayo Clinic, 4. Combination drugs, 5. Stifel and ASH health conferences, 6. no negatives, 7. patients needs, 8. unique remissions, 9. end of tax loss selling, 10. better public relations.
I think you are correct. Provenge seems to work at some level as a vaccine (proof-of-concept), but the demand may not be there. IMET, as a telomerase inhibitor, has a huge potential with proven results. Here we are talking about preventing cancer (vaccines & telomere control are proven to a point), which is an entirely new subject, but one that is being pursued. JNJ has very deep pockets for investigation.
Actually there are 3 categories: vaccine, immunotherapy, telomerase that have been in the news as part of advanced-cancer-research. IMET seems to be very well situated with Mayo's trials and medical science as a solid anchor, plus JNJ/Janssen's very deep pockets and interest in all areas of oncology (with the current IMET emphasis on MF, MDS, and AML) for the future. In 2015 there will be much more interest in using IMET in combination with other drugs for other cancer treatment possibilities.
NEW YORK, NY / ACCESSWIRE / December 1, 2014 / With the recent bankruptcy of Dendreon Corporation due to disappointing sales of its flagship Provenge prostate cancer vaccine, the future of cancer immunotherapy just got a bit cloudier. While Provenge itself will survive, Dendreon may end up going private in a debt restructuring deal.
But while it may look grim now, the fact remains that sales of Provenge will reach the $300M mark this year, a nice sum for any company from startup biotech to Big Pharma. It just wasn't enough to overcome the debt incurred to develop it. Clearly then, there is a significant market for cancer vaccines. The trick is to develop the treatments at much cheaper cost.
Vaccines though, are only one approach of two when it comes to cancer immunotherapy. In a vaccine like Provenge, the goal is to stimulate the immune system to build indigenous antibodies against a given illness be it a tumor or a virus. The second approach is to engineer the antibodies themselves and use them directly as the treatment.
This second approach is known as monoclonal antibodies or mAbs, where the immune molecules are usually engineered using antigens and then humanized and cloned. The advantage over a vaccine is that monoclonal antibodies are generally more targeted than vaccines, since the effectiveness of a vaccine depends on effective antibodies being produced by the patient in response to it, while the antibodies themselves are already engineered to be effective on a specific disease. The disadvantages are that unlike vaccines used to train a patient's own immune system, sometimes engineered and then humanized monoclonal antibodies can trigger extreme side effects by causing an immune overreaction.
Be that as it may, the whole monoclonal antibody market is huge. Already 8 years ago it passed the $20B mark, and is expected to pass $140B in just three years. While Provenge is and remains the only FDA approved cancer vaccine, 17 monoclonal antibody
I believe that IMET is a "remarkable" drug, but others have been fooled (Provenge), so I am limiting my Geron investment, and not betting the "house".The shorts believe that Geron is another Dendreon in the making (blindsided), and are investing according to their belief. What happened to Provenge?
"Dendreon Corporation (Dendreon) is a biotechnology company focused on the discovery, development and commercialization of therapeutics that may significantly improve cancer treatment options for patients. The Company's product portfolio includes active cellular immunotherapies and a small molecule product candidate that could be applicable to treating multiple types of cancers. PROVENGE (sipuleucel-T), is the Company's first commercialized product approved by the United States Food and Drug Administration (FDA), and is a autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic, metastatic, castrate-resistant (hormone-refractory) prostate cancer. The Company owns worldwide rights for PROVENGE."
CHKP is the "best of breed in the most important of all industries." SONY went with FEYE so they must also be among the best in this cyber-security-industry. There are huge opportunities here for the veterans (CHKP--~$15B), and the smaller companies (FEYE--~$5B). I own both.
FireEye looks like they have the right product at the right time. They should be enough business to go around.
Stifel, Piper-Jaffray, and ASH health conferences all pointed the way for MF, MDA, and AML studies and trials. Mayo Clinic and JNJ/Janssen are a powerful one-two punch to move IMET ahead for patients and researchers, with the FDA onboard. From what we know, IMET is a "remarkable" medicine, with relatively few side effects (for a cancer medicine), and Geron will be a major beneficiary in 2015.
There is a lot of history that goes into what you say,"a racial divide in America", and it has to do with two nations that are contained in one. It is divided (more or less) by the Ohio River and its east-west extensions (Potomac R., Missouri R., etc.). These conflicts go back to the slave trade, rum and sugar, and will not be totally resolved until 2165 (300 years after the Civil War), IMO.
This is extremely frustrating, to say the least. There isn't much to believe in anymore, with the 3 religions of Abraham being the worst (lack of science, evil and corruption) in their fundamental forms. However, I still believe that the "4 Horsemen", are honest, and are working for the ultimate good (better human health and a cure for cancer). IMET, I believe, is real and remarkable, and also a good long term investment, that will make 2015 a very good year for the PPS. I have Stifel and ASH recent health conference's to back me up.
Imetelstat (IMET) has everything going for it from the medical, research, scientific and patient point of view. It is all happening behind closed doors and in secrecy now. $5 will happen in an instant, perhaps tomorrow, or next week (2014), or soon after the Jan. 1.
MacroGenics teams up with Janssen in blood cancer (12/2/14) •
•MacroGenics (MGNX +11%) enters into a global collaboration and license agreement with Janssen Biotech (JNJ +0.8%) for MGD011, a humanized CD19 x CD3 DART protein, for the potential treatment of B-cell malignancies. MGD011 is based on MacroGenics' proprietary platform for Dual-Affinity Re-Targeting (DART) to simultaneously target CD19 and CD3.
•Under the terms of the agreement, MacroGenics will receive an upfront license fee of $50M, up to $575M in various milestones and double-digit royalties on net sales as well as the option to co-promote the product with Janssen in the U.S.
•Janssen will invest $75M in MacroGenics via the purchase of 1,923,077 shares of common stock at $39 per share and will be fully responsible for developing MGD011. It expects to submit an Investigational New Drug (IND) application to the FDA in 2015.
•MGD011 is designed to redirect T cells, via their CD3 component, to eliminate CD19-expressing cells found in many hematological malignancies.