Whatever Mayo says and does with the clinical trials will determine Geron's and Imetelstat's future. That may take a week, a month or longer. The outcome, IMO, will be very positive for patients, researchers, and long-investors. Shorts and manipulators cannot outlast good science and good medicine, but their effort is "heroic".
For this concept to die (Imetelstat, telomeres, remissions, etc.) Mayo would have to go negative. That has not happened. The full story (to date) will be published by Mayo sometime soon. The complete story is a continuing story that will take years to complete as new paths are explored.
There are some questions about "low-order" liver abnormalities that appear to be similar to those side-effects found in other medications (Tylenol for example). The FDA is very cautious, underfunded, and undermanned. They need time to sort and consolidate data. Buy by all means. Mayo is a solid source of honest information.
All good: Remissions, Cures, Pipelines. FDA is shorthanded, and needs time to get on board. The $5 median will soon be restored, as all realize that side effects are manageable and Imetelstat is safe.
Mayo is telling the FDA (at this moment) that the "hold" is not necessary and not wise. This "hold" is for the FDA's internal use, since they need time to catch-up. They have limited resources, and few people assigned to this project.
Most of the confusion could be cleared-up if Mayo would put out a "white paper" on: (1) patients progress, (2) side effects, (3) safety issues. Mayo is trusted by most people to be honest and forthright. They know the truth, and will be believed.
It appears to me that the life saving qualities (PCR) outweigh by far the low-order (NLA). That should be reflected in a recovery of the stock going forward.
Imetelstat & Geron are now large investments of Merrill and Fidelity. They will likely add to their holdings, based upon the true market potential here. It seems reasonable to me that we will have a quick recovery. There is money on all sides, and the sensitivities to any news (real or imagined) are enormous. The truth is still in question in the minds of many.
These liver peculiarities (low-grade) are nothing new and nothing dangerous, especially when the primary problem is potentially fatal blood cancer. Mayo is prepared to defend its clinical data plus CR's, PR,s, CI's and continuing trials. Good medicine will always come-out on top. Mayo can be trusted 100%. The FDA is being cautious, and that is part of their job.
These are "low-grade" problems that are likely reversible, non-toxic, and non-life threatening. The Imetelstat story of CR's, PR's, CI's, possible cures and an extended pipeline is still very much intact. The FDA is correct in taking a close look at this before final approval. The FDA is doing its job. Mayo Clinic has the data, and it still looks very good. These side effects are nothing new.
The FDA wants to look into this liver peculiarity in detail. This may be the last obstacle before approval, or disapproval. The FDA does not want to create a liver problem that is potentially worse than the original cancer problem. Since some people have been safely on Imetelstat for a considerable time, that seems highly unlikely. This is the FDA being very cautious, before they "bless" a potential cancer revolution (telomeres, cancer stemcells). This is the time to deal with this situation, not after approval. If the FDA is going to kill Imetalstat, they should do it now in full view.
Mayo will have to defend the medicine, or admit they have been very wrong. These are their clinical trials, and their reputation is on the line. At this point in time, it appears that the benefits of Imetelstat outweigh the risks. We shall see. The FDA is awake.
KEY WORDS: low-order, non-toxic, lifetime (of cancer patient), risk
The LFT (liver function test) problems have been known about for awhile, and appear to be minor compared to the cancer considerations. Imetelstat's overall safety profile is good over an extended period. All cancer treatments have some side effects (especially chemo). Few can talk about CR's, PR's and potential cures. We will see why the FDA jumped on the "low-level" liver problems at this time. Hopefully, this is only a bump in the road. Dr. Tefferi must have known about this, and considered it to be a tolerable problem.
The CR's, PR's and CI's are still with us. " Low-grade" is important. Compare Imetelstat side effects with other cancer drugs; Imetelstat will still do well. This has to do with the quality of life and longevity after treatment.
Safety is now an issue (liver). Key words: low-grade, reversible, long-term, dose, liver. Is the disease worse than the cure? There is still much hope, with an obvious setback.
Bloomberg (Mar.12)--"The U.S. Food and Drug Administration told Geron to place a clinical hold on its mid-stage trials of imetelstat because of low-grade liver function test abnormalities. The regulator cited the potential risk of chronic liver injury following long-term exposure to the drug, Geron said in a statement today.
“The FDA expressed concern about whether these LFT abnormalities are reversible,” the company said. “Geron plans to work diligently with the FDA to seek the release of the clinical hold.”
In November, Geron reported data showing imetelstat helped patients with myelofibrosis, a bone marrow disorder, sending the shares up the most in more than a decade. The clinical hold applies to studies in essential thrombocythemia, polycythemia vera and multiple myeloma. Geron said it’s likely that a planned mid-stage study in myelofibrosis will be delayed."
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Someday we will get a meaningful update, that most of us believe will continue to be positive. Could be tomorrow, should be tomorrow, but may not be tomorrow. Obviously, this stock is easily manipulated, but good-medicine will issue the final verdict. At some point, the FDA will wakeup from their leisurely nap, and decide to save some lives.
There were actually 6: PLUG, MY, GERN, OXBT, VMEM, CDTI . CDTI (Clean Diesel) is booming today. Geron needs to catch on fire, with FDA "blessings".