Recent

% | $
Quotes you view appear here for quick access.

Cisco Systems, Inc. Message Board

lws2000 246 posts  |  Last Activity: 12 hours ago Member since: Nov 21, 2001
SortNewest  |  Oldest  |  Highest Rated Expand all messages
  • Bear Raid defined: "an attempt to lower a stock or commodity price by selling large numbers of shares, usually in order to buy them back at a lowered price".

    There does not appear to be any medical, scientific, or Geron specific reason for this sharp, quick price decline from near $4 to near $3. Janssen would not have setup 65 trial sites worldwide, and the FDA would not have granted ODD status if there were any serious lingering problems with IMET. IMET brings remissions to blood cancer patients.

  • There is no question that JNJ/Janssen would not be opening so many trials around the world unless they were absolutely sure of the results (within statistical limits). Since they are going into these trials (39 at last count) with the full knowledge of Mayo Clinics successes (remissions, improvements, stabilization), the probability of their continuing success is very, very high. JNJ is going for universal approval for IMET from the FDA and similar agencies worldwide. The uses for IMET in most cancers and beyond (aging for example) are many and varied. The blood cancer cousins are first in line. The FDA has already granted Janssen Orphan-Drug-Designation (ODD).

    This is the order that JNJ/Janssen will bring telomere modification into the lives of cancer patients (and perhaps others), but there will be considerable overlap. Imetelstat is already a success with Orphan-Drug-Status already in its procession. The 39 international sites will reinforce Mayo Clinics original progress, which brings remission to some, and benefits to most (80% in MF).

    The Order of Things (decades of research):
    1. MF
    2. MDS
    3. AML
    4. Combination Drugs
    5. Telomeres in general, including cancer stem cells, solid tumors, and aging

  • The comparisons between IMET and JAK will be made on two levels; first general symptoms such as spleen size, and second on the number of remissions and partial remissions. The good news about IMET has been continuous and for the most part ignored:

    1. Tantamount to a Cure (Mayo Clinic)
    2. Liver-holds lifted by FDA
    3. JNJ/Janssen, partner
    4. ODD (Orphan Drug Designation) from FDA
    5. 50 or so international trial sites to get worldwide approvals for IMET
    6. Direct comparison coming between IMET & JAK

    The good news is finally being believed by more investors, as the short hedge funds lose steam. These new international trials will answer most outstanding questions about IMET, MF and other blood cancer cousins. They will also continue the study of combination medicines (example AML in Australia).

  • There are no "nonbelievers" in the medical community. IMET has been proven beyond any doubt (Mayo Clinic original trials --"Tantamount to a Cure" , FDA early approval--ODD; Orphan Drug Designation, JNJ/Janssen's international trials with a direct comparison between IMET (remissions) & JAK (no remissions) coming.

    There are no hurdles or obstacles in the path of JNJ/Janssen (and by association, Geron) from the medical or the scientific community. IMET is effective, safe and unique, and is in the process of getting worldwide recognition and approval. There are no negatives, and huge potentials (blood cancers, all cancers, aging).

  • Once a day this list of 10 (from Irish) needs to be reviewed. It was originally submitted on March 8. It is still all true. JNJ/Janssen's global trials is the other huge factor. The "New Geron" looks very solid now, and very promising in the future. All of these items are true.
    --------------------------------------------------------------
    10 Things Believers Believe

    1. Imetelstat induces unprecedented molecular and morphological remissions and bone marrow clearing in substantial numbers of MF patients; and a substantial overall response rate (80%).
    2. Likely induces similar results in other myeloid cancers (MDS/AML).
    3. Potential for other applications in cancers that express telomerase (90%).
    4. Minimal quality-of-life side effects (nausea, hair loss) and other suppressive effects easily managed.
    5. Two-year MF/MDS/AML IST study ("Phase" 1) is nearing completion. (Could this qualify as "basket" study?)
    6. Data reported qualifies for accelerated, fast-track, BTD, and/or orphan drug status based on my personal amateur analysis. Due own due diligence.
    7. Phase 2 and any other follow-up studies are likely ending design/planning stage and entering enrollment stage relatively soon.
    8. Partnership with subsidiary of world's largest pharmaceutical and established collaboration with Mayo Clinic Rochester.
    9. Interest in other cutting-edge biotech companies with active research (ASTY, BTX); and potential/existing revenue streams (Sierra Diagnostics).
    10. 260+ patents for telomerase.

    Plus cash, tax deferments, lean operations.

    John still doing very well (normal life) in active not participating trial status. He is in good hands with bright Imetelstat future ahead.

    ```````````````````````````````````````````````````````

  • Something is happening. IMET is being publicized by JNJ with 36 or so international trials, the FDA is taking notice (ODD), and the medical successes are being believed by more investors. At the close, Geron is up 1%, while the S&P 500 is down 2%. Geron, I believe, has turned the corner, but the road higher will still be bumpy for awhile with the upward trend continuing.

  • Reply to

    Geron under pressure

    by lws2000 Jul 27, 2015 5:45 PM
    lws2000 lws2000 Jul 27, 2015 7:03 PM Flag

    There are no "nonbelievers" in the medical community. IMET has been proven beyond any doubt (Mayo Clinic original trials --"Tantamount to a Cure" , FDA early approval--ODD; Orphan Drug Designation, JNJ/Janssen's international trials with a direct comparison between IMET (remissions) & JAK (no remissions) coming.

  • Reply to

    Thoughts on the litigation

    by rattllebug Jul 7, 2015 5:36 PM
    lws2000 lws2000 Jul 7, 2015 5:44 PM Flag

    Clearly this was a "frivolous-litigation" that tried to take advantage of Geron, when they thought they had an upper hand, and Geron was disadvantaged. Geron did nothing wrong, as you have shown. If anything, Geron should be owed some compensation.

  • This is the likely order that JNJ/Janssen will bring telomere modification into the lives of cancer patients (and perhaps others), but there will be considerable overlap. Imetelstat is already a success with Orphan-Drug-Status already in its procession. The 39 international sites will reinforce Mayo Clinics original progress, which brings remission to some, and benefits to most (80% in MF).

    The Order of Things (decades of research):
    1. MF
    2. MDS
    3. AML
    4. Combination Drugs
    5. Telomeres in general, including cancer stem cells, solid tumors, and aging

  • The volatile markets are not helping Geron, but the PPS has held above $4 in a generally unfriendly market.

  • Reply to

    Bear Raid by some very clever people

    by lws2000 Aug 14, 2015 3:01 PM
    lws2000 lws2000 Aug 16, 2015 12:21 PM Flag

    If I am correct (which sometimes happens) the Geron PPS should start back up on Monday and be back to $4 in a short time (a week to 10 days). IMET's management is now controlled by JNJ, and the FDA has shown positive inclinations (ODD) toward IMET. Some of the 65 or so trial sites will start infusion very soon, and confirming data will follow (%'s of remissions, improvements and stabilizations). Remember that JNJ is treating the sickest of MF patients in these new trials with IMET, that have tried JAK and given-up hope.

  • The 36 new JNJ global trial sites will be trying to answer that question. The fact that IMET brings about remissions at all is surprising, and tied somehow to "telomere-science". However, that begs the question of why some people get remissions, some partial remissions, some significant improvements, and some stabilization. I read a statement, that I cannot verify, that about 80% of MF patients benefit from IMET. These new trials will establish markers and indicators, that will increase the understanding of the science.

  • Summary: The evidence indicates that Imetelstat (IMET) is safe, effective, unique and saves lives. From what I have read, Imetelstat, for a cancer medicine, has a good safety profile, with over 500 test subjects over several years. Also, I have read that, in the Mayo MF trials, there were some complete remissions, some partial remission, some improvements, and some stabilizations. In all, about 80% of MF patients showed some benefit. JNJ/Janssen is at the beginning of starting 36 or so global trials (USA and internationally) to gather new data and to enhance the original Mayo MF trials. Since JNJ has seen all of the data to date, and now has ODD approval from the FDA, they must be highly confident. Imetelstat appears to be in a class by itself, since telomere shortening is a factor in most cancers, including cancer stem cells.

    Please edit or correct any wrong or misleading statements.

  • The consensus is that Mayo Clinic was meticulous is their initial MF trials (Chapter 1), and Janssen will be able to confirm these earlier results and successes. The FDA granting ODD status to IMET is the end of Chapter 1.

    Chapter 2 concerning the usefulness of and understanding of telomeres in the treatment and prevention of cancer is currently being written. In addition the comparison with JAK will be based upon the number and quality of remissions, plus symptoms' improvements.

  • 1. ODD now allows use of Imetelstat in primary orphan drug designation (MF) and in any other indication; and is gateway to MF (and other) registry studies.
    2. ODD allows for a Fast Track procedure to evaluate registration files.
    3. ODD reduces waiting period and provides priority FDA review of new drug applications (6 months instead of 10 months).
    4. ODD takes, on average, 30% less time to market (3.9 years vs 5.4 years).
    5. ODD allows smaller studies with no placebo required.
    6. ODD provides FDA technical assistance during the elaboration of application file and in design of protocols including written recommendations in clinical and preclinical studies
    7. ODD has higher rates of approval 82% compared to non-orphan at 35%. Of the 36 new drugs launched in 2013, 17 were ODD.
    8. ODD provides availability to patients before market approval when disease is life-threatening, no equivalent treatment is available, and drug in clinical trials and active phase of marketing approval.
    9. ODD provides 7 year exclusivity (monopoly) after market approval.
    10. ODD provides up to a 50 percent research-and-development tax credit on US trials.
    11. ODD waives drug approval application fees and annual FDA fees.
    12. ODD application required disclosure of risk/benefit data and
    13. ODD allows for development of personalized and predictive cancer treatment that target patient populations with a specific cancer causing mutation.
    14. Almost 1/3 of orphan drugs earn more than 1 billion in annual sales. Category has more than 50 billion annually in world wide sales and rising 20% a year past several years.
    15. ODD has produced "rolling blockbusters" - drugs initially may be approved for one indication in a small population, but later acquire additional uses after longitudinal studies and real world observations (registry studies).

  • lws2000 lws2000 Jun 23, 2015 8:32 PM Flag

    "First, because telomere shortening and consequential tumor growth inhibition require many cell divisions, single-agent telomerase inhibitors require substantial time to significantly decrease tumor growth. Second, telomerase inhibition typically results in only a cytostatic effect, which allows tumor cells to acquire secondary genetic and epigenetic alterations resulting in drug resistance. Finally, single- agent telomerase therapeutics often fail due to activation of ALT pathways, which bypasses the requirement for telomerase." (previously presented on this board)

    JNJ/Janssen partnered with Geron because "telomere shortening" is fundamental for remissions and possible cures for assorted cancers. The road to a cure seems to combine other medicines with IMET, although MF has been tamed with IMET alone (to date). JNJ has combined one of its own drugs (Doxorubicin) with IMET to treat AML (an MF blood cancer cousin). The last that I heard, those studies were happening in Australia with considerable promise. It appears that IMET, in combination with other drugs, becomes a more powerful force. The cure for cancer will involve IMET, but not as a "single-agent". Each form of cancer will involve telomere-shortening, plus some other treatment, for optimum results. There is much to be learned.

  • lws2000 lws2000 Jul 15, 2015 11:26 AM Flag

    This is a great question, and is the same question that every long term investor asks. For whatever reason, there seems to be little trust of Geron, even though JNJ/Janssen now controls IMET and its medical future. It makes no sense (IMO), but the PPS depends on investor psychology as well as medical fundamentals. The "ship" will right itself, as good news about IMET continues.

  • For those that are not convinced about the safety and efficacy of IMET, please wait to the end of the JNJ trials to make investment decisions. I have decided that Mayo Clinic cannot be wrong about IMET.

  • These JNJ global trials will define IMET. The case for IMET seems overwhelming from a medical and science prospective. JAK appears to be a different class of drug that only treats symptoms. In IMET's case we are talking about a basket (blood cancer cousins; MF, MDS, AML), durable remissions, and possible cures, with telomere control feasible in 90% of all cancers. It appears that JNJ/Janssen has decided to take a very conservative approach by setting up 30 or so global trials to reproduce and expand upon Dr,Tefferi's MF successes at Mayo Clinic.

    In some MF patients positive IMET results are seen as early as 3 to 6 weeks, it has been said. JNJ has seen all of the data and has drafted Dr. Tefferi to lead these trials, so they know that they will get good, great or miraculous results. The unique part of these 24 week trials, is that these patients are the sickest of MF patient's that have previously used and quit JAK .

  • Reply to

    Question

    by wysgramps Jun 12, 2015 3:54 PM
    lws2000 lws2000 Jun 12, 2015 4:05 PM Flag

    This leaves the door open for Mayo Clinic to try IMET on all of the blood cancers (MF, MDS, AML) and other cancers.

CSCO
25.90+0.25(+0.97%)Sep 3 3:59 PMEDT