Imetelstat science and medicine are both sound. The politics at the FDA and the price of Geron's stock are related issues, but have nothing to do with patients' welfare. Patients that are being treated with Imetelstat for MF are benefitting with remissions, while others with MF are dying. There is nothing else.
NOTE: These excerpts from a previous discussion tell the full story. Basically Imetelstat works, while all other treatments fail (remissions, cures, cost, etc.) There is nothing else.
#######FROM prescient2001 (negative argument)
Cost per treatment hasn't been discussed recently. It sounds like Irish's husband currently is benefited most by infusions every 6 weeks (approx 9x/yr.). To the degree it's quickly covered by insurance, great, but, if Jakafi is significantly less expensive, it might remain the treatment of choice for older patients. A drug combo with Jakafi may not be a money saver if the same amount of Imetalstat is required to successfully treat the cancer.
******** FROM irishtrader52 • 4 hours ago (positive facts)
Jakafi is not an option due to minimal efficacy/severe side effects/lack of durability and not less expensive as Jakafi patients get sicker and sicker costing much much more in medical costs than patients in remission. Our insurance company has easily saved huge costs the past 18 months thanks to Imetelstat! Transfusions alone - and Jakafi can accelerate the need to transfuse - would have cost more than Imetelstat not to mention the hospitalizations and hospice care needed as his organs slowly shut down one organ at a time and he bled out slowly. MF is a slow agonizing way to die - a "wasting" disease.
Imetelstat and Mayo Clinic's MF trials and successes are one of the most important, productive paths in medicine today and tomorrow. Mayo controls Geron's future with written agreements and contracts. That works well for everyone (patients, investors, Mayo, Geron, FDA). ASH is coming soon (abstracts in early Nov., Conference in early Dec.). The future of Geron will also come out of the fog, as more and more information is released.
When the #1 medical organization is featuring the cancer blood drug, Imetelstat, in their internationally distributed brochure, there can be no question about its positive qualities. The FDA seems to be onboard, and has released the Mayo holds (liver thoughts) that now seem to have been ill advised. What will Mayo do next to promote Imetelstat? We may find out next week (Geron conference call Aug. 11). I don't think we will have to wait for ASH (abstracts 1st week in Nov., meeting 1st week in Dec.) for new, positive, important information.
You have misspelled the President's name. The correct spelling is Obama. Please be careful. Putin is a megalomaniac, that no one understands, and has started WWIII Light in the Middle-east (Syria) and Europe(Ukraine). Russia, under Putin, is a threat to all Americans. This is a Geron board, but freedom of speech cannot be denied. Go elsewhere please.
In a strange way, the interest in IMET (cancer, non-infectious) has increased with infectious disease considerations (Ebola). Geron is about to become a market leader, as ASH abstracts (Nov. 6) and ASH (Dec. 6) presentations become public information. Human survival is front and center.
We should know more after the Conference Call at 4:30 ET tomorrow. Tefferi appears to be in control of Imetelstat's future with Mayo, Geron, and the FDA all cooperating. This should be good for the patients and the Geron investors, as well as Mayo (#1 in USA research hospital). Tune in tomorrow.
Tefferi is still at Mayo, but is also is the leader of the MF studies at Geron (new and continuing). Mayo's lifted hold allows both Geron and Mayo to move forward with MF, and other "off-label" and new possibilities. Scarlett can seriously bring aboard a deep-pocked partner, with the proper blood cancer credentials. The FDA can put the Geron hold on the back burner as unimportant, since it has nothing to do with MF. Combination drugs can be contemplated. The FDA saves faced for imposing an ill-conceived liver hold. Geron gets to manage all projects using Imetelstat, and Mayo keeps a hand in all of the research. Cancer patients benefit the most. Geron investors get support from the whole "team", and will benefit. Market manipulators have to reevaluated their short positions.
“Previous studies had suggested that once assembled, telomerase is available whenever it is needed,” says senior author Lundblad, professor and holder of Salk’s Ralph S. and Becky O'Connor Chair. “We were surprised to discover instead that telomerase has what is in essence an ‘off’ switch, whereby it disassembles.”
Understanding how this “off” switch can be manipulated–thereby slowing down the telomere shortening process–could lead to treatments for diseases of aging (for example, regenerating vital organs later in life).
Lundblad and first author and graduate student Timothy Tucey conducted their studies in the yeast Saccharomyces cerevisiae, the same yeast used to make wine and bread. Previously, Lundblad’s group used this simple single-celled organism to reveal numerous insights about telomerase and lay the groundwork for guiding similar findings in human cells.
“We wanted to be able to study each component of the telomerase complex but that turned out to not be a simple task,” Tucey said. Tucey developed a strategy that allowed him to observe each component during cell growth and division at very high resolution, leading to an unanticipated set of discoveries into how–and when–this telomere-dedicated machine puts itself together.
Every time a cell divides, its entire genome must be duplicated. While this duplication is going on, Tucey discovered that telomerase sits poised as a “preassembly” complex, missing a critical molecular subunit. But when the genome has been fully duplicated, the missing subunit joins its companions to form a complete, fully active telomerase complex, at which point telomerase can replenish the ends of eroding chromosomes and ensure robust cell division.
This research was supported by the NIH the Fritz B. Burns Foundation and Rose Hill Foundation
PREVIOUS ---"The new idea is that Imetestat and Geron can be separated. Dr. T now wears 2 hats (Green for Geron & Mango for Mayo---what color is the combination?). He can coordinate trials under each hat, or combine them when appropriate. The FDA will be presented with the best of both worlds, and the FDA will be happy, happier, happiest."
The belief is that Imetelstat is a good, successful, worthwhile drug, or we have all been deceived. If Imetelstat works and is both safe and effective (a given), then the FDA has every reason to make it available to all MF victims, ASAP. As many have said, there are flaws at Geron (data collection & omissions primarily), but Imetelstat is a great drug. I think, that full clearance by the FDA, will happen before ASH, but obviously, I don't know. As a long term investor, I can wait, unless there has been deception about the quality and viability of Imetelstat (Mayo can be trusted). Someday soon, Geron will have a major partner or be merged out of exsistence; that will move the PPS much higher.
PREVIOUS---I don't believe that the FDA has any reason or motive to keep Imetelstat (IMET) off of the market. In fact, I believe just the opposite, and ASH will be the vehicle for lifting all of the impediments that have been placed in IMET's way. Geron got caught in an ill-conceived and unnecessary liver hold, that may have been their own fault in part. The Mayo-Geron association, with Dr. Tefferi at the center, was put together to undo this unfortunate situation. There is every reason to believe that ASH abstracts (early Nov.) and ASH (early Dec.) will bring good news, and get the FDA off of our backs.
The "Liver-Hold" had nothing to do with the quality, safety or the effectiveness of IMET. Liver problems were on the mind of the FDA from difficulties in other (non-IMET) studies. Geron and Mayo both were caught by surprise, with Geron in the much weaker position, at the time, to respond. Mayo had the successes of their MF studies (ASH 2013). The presentations at ASH (2014), and perhaps before, will put everything into proper perspective, with IMET the likely winner.
Thank you for the information. This reinforces all of the hopes for IMET as a top-drug for cancer now, and ultimately for aging. Telomere-telomerase research is at the very beginning.
My Opinion: Scarlett, Tefferi and the FDA talk to each other, and have an agreement in place. Mayo and Geron are combining their data to conform to the FDA's procedures and wishes. The reasons for the level of secrecy, that you talk about, are not clear (partner discussions, inside information, FDA direction ???), but everything seems be under control as ASH approaches. I am confident that Imetelstat is already a success from the medical point of view. There is hedge fund manipulation of the small biotechs (other posts on this board), and Geron appears to be a victim. If I am correct, the PPS cannot be held down much longer, as more news about Imetelstat becomes available. ASH and ASH abstracts will put everything into perspective.
There is no way that Imetelstat can fail at this late date. Mayo and Geron have combined their data in such a way that the FDA cannot ignore the successes, including improvements, remissions and cures. ASH will amplify these successes.
The obvious question is: Why is a safe and effective cancer drug being held off of the market? The obvious answer:There is no good medical reason, but there may be political and competitive reasons.
I am waiting for someone to show where Mayo and Dr. Tefferi have been wrong, in any sense, about the safety and effectiveness of Imetelstat. They cannot do this, because they have been careful, honest and successful. The conference call @ 4:30 PM ET (Monday) should be informative, with additional positive news.
Imetelstat is too good of a drug not be absorbed by a giant. Amgen-Geron or Gilead-Geron still look like good bets to me. It is going to happen, IMO. Mayo will likely have a big voice in this decision.
PREVIOUS********Imetelstat's future will be determined by the presentations at ASH. We do know that Mayo Clinic, NCI, Amgen, Yale Medical and others have some very interesting and important thoughts and results to share. ASH will open new paths into the future of medicine ( telomeres-cancer-cancer stemcells).********
There is no way that Imetelstat can be kept out of the reach of needy patients, and off the market considering the information that is coming from Mayo, NCI, Amgen, Yale, Mass. Medical, etc. The Geron-FDA impasse is a mystery, but it may be as simple as the FDA making a mistake, and trying to find a good way to save face. This is unfortunate. I don't believe there has been any corruption, but I am less sure about politics, considering that other products would be impacted by Imetelstat's "green-light". The combination of data (Mayo-Geron), with the FDA's apparent approval, looks very positive.