JNJ/Janssen has changed the terrain, and Geron is now supported by two giants (Mayo & JNJ). I doubt if they will take any $#!+ from the FDA. There is "breakthrough" in the air, following Dr. Tefferi's ASH presentation.
Dr. Scarlett has been at most of the health conferences promoting Imetelstat (IMET). Traders do not seem to be paying much attention. I see Dr. S as a spokesman for the newly formed JNJ-Mayo-Geron team, with JNJ/Janssen now the major player with deep pockets, oncology expertise, global presence, and FDA influence.
We will see if JNJ has given Dr. S some new talking points.
The FDA is well aware of Imetelstat (IMET) and its curative properties that have been continually demonstrated at Mayo Clinic (MF, humans). Many of these remissions are still in place, two years after the initial treatments. Safety is not an issue, and recently combination drugs have been shown to enhance the positive effect (AML, mice).
I suspect the FDA has already made a decision. The NEW GERON (JNJ/Janssen & Mayo Clinic as partners) certainly know all the rules and procedures, and how to interact with the FDA. The FDA has no reasons left to withhold some type of approval. The liver-holds are gone.
The FDA has been very slow, but will eventually do their job. Advanced approval is on the table.
Imetelstat (IMET) is currently successful in MF trails in humans at Mayo Clinic ("Tantamount to a Cure") with full remissions. IMET is the perfect medicine for the advanced approval that the FDA has been advocating (MF, AML, MDS--blood cancer cousins). IMET meets all the criteria: uniqueness, needed in a life threatening disease, safe, proven, no alternatives. Fast track and breakthrough approvals should have happened yesterday. The FDA knows all of this, and JNJ is there to constantly remind them. Approval is coming very soon, since there are no alternatives, and the patients require IMET now. Less
I fully expect JNJ to be able to prove to the FDA that IMET is worthy of advanced approval. In addition, considering the "reach" of telomeres in the survival of cancer cells and immortal cells, I believe that there will be tests and trials in many parts of the world using IMET alone or in combination with other drugs. The FDA is important, but they are not the only game in town.
JNJ/Janssen is an international pharmaceutical company, with partners all over the world. It has been stated that the telomere-telomerase interaction (IMET) is important in 90% of all cancers. (Why not 100%?) We know about the AML project in Australia. There must be others that are getting off the ground. Can anyone sight some incipient studies?
Imetelstat is "Tantamount to a Cure". JNJ/Janssen has confirmed that, and the FDA is about to act.
These seem to be the prevalent views of the market-controlling short hedge funds. I am sure they will be trapped by the FDA and JNJ's announcement of advanced-approval for IMET. I am frustrated by the slow progress, but still believe that the patients' needs will be the deciding factor. IMET's medical successes are now documented, and cannot be denied. IMET is a safe and effective blood cancer medicine.
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This is a chance for Dr. S to put all of his detractors in their place. Dr. S brought JNJ and Geron together, bringing stability and leadership to "a one drug company" with great potential. He could have sold the company outright, or have tried to go it alone. He chose a middle ground, that keeps Geron alive, but reduces the risk of failure, and, IMO, that was the best decision possible. Now as a lead spokesman (with Dr.T) on a balanced science and medical team, this is the time and place to Shout about IMET ("Tantamount to a Cure" and Beyond).
The hedge funds are interested in making money, and form the bulk of the shorts that keep GERN's shares in a narrow channel. They are aided by sophisticated computer programs. GERN has been perfect in their world. IMO, IMET is too good, and JNJ is too well connected for this to go on much longer. This is truly a tug of war that is yet to be resolved, but, I believe, Science & Medicine will win.
The "Veil of Silence" is being strictly enforced by JNJ/Janssen, as they reach out to the FDA for the "new-go-ahead" rules. There will be plenty of time for shouting about IMET's miracle properties. The FDA approval is critically important in the USA, and no medicine can succeed without its approval here. Outside of the USA it is a different story. We have seen drugs approved for use in Europe, before they were granted approval in the USA.
"Tantamount to a Cure" is a description of Imetelstat (IMET), that was coined in 2014, and they still fully support. Considering Mayo Clinic's history and outstanding reputation, there can be no question about IMET's remissions and life saving properties in MF and beyond (MDS, AML, etc.).
IMET is a blood cancer drug that works, is safe, is unique, and is needed now. IMET and the JNJ-Mayo-Geron partnership team appear to have no opposition speaking medically and scientifically. The hedge funds and other shorts are loosing "steam" and credibility, and are "melting-down", like that famous witch. Patient's needs come first, and the FDA certainly knows that. With JNJ/Janssen and Dr. Tefferi now in charge, all is well.
The only place that we disagree is about Dr. Scarlett. I think he was blindsided by the FDA, which allowed itself to be influenced (unfairly, IMO) by another drug company (perhaps Incyte or Novartis) in placing a hold on Geron. This gave the shorts an unearned advantage (PPS), which they have managed to maintain for now. I think he performed his job at a high level by bringing Dr. Tefferi to Geron (as a second job), and getting JNJ/Janssen Biotech as a partner with very deep pockets. This cemented both Mayo Clinic and JNJ to Geron as very interested partners, creating a powerful team to deal with the FDA.
"5. Two-year MF/MDS/AML IST study ("Phase" 1) is nearing completion. (Could this qualify as "basket" study?)"--from Irish
"13. Geron website describes the early stages of the MF/MDS/AML study through January 2014 when it stopped enrolling patients as the Pilot Study. Now that study has continued another year+, Geron refers to it as a Phase II study. Could we be farther along than we know?"--from Irish
It looks like "Basket Study"="Stealth Phase 2 ". The FDA has to know exactly what is going on, especially with Janssen and Dr. Tefferi doing the explaining. I believe that the so-called silence is about to end.
The studies seem to have progressed beyond MF alone, into the whole group of blood cancers (a basket--MF/MDS/AML, and beyond the USA and the FDA [AML, Australia & Dr. Lane, for example]). Events seem to be moving very fast, there are no significant negatives or safety issues (IMET), and positive news keeps coming from the health conferences. The needs of patients has to be the #1 consideration.
I beg to differ with you. "IMET meets all of those criteria" IMET works and is safe. IMET saves lives. Most important it is unique and "Tantamount to a Cure". Those are all of the reasons needed for "advanced approval". The evidence is obviously overwhelming, and the "follow-up studies" will continue.
I did not think it was possible to manipulate a stock for this long with so much good news (safe, effective, strong partners, FDA holds lifted, CR's PR's CI's and potential cures, combination drugs, conferences all positive) that seem to go on and on. There is no evidence of a hoax or fraud, especially with Mayo Clinic and JNJ as partners. The PPS is controlled, but one day it will be released like a rocket. So far my guesses about the time and date have been completely wrong, but someday it will happen.
The Geron PPS has been held in a channel from 2.95 to 3.95 by very "talented" hedge funds, and has been a good source of income for them. Geron will have to break over $4 to get out of their reach. At $5, all the institutions, that now require that price, will become interested, so the PPS should trend upward at a steeper slope. Also Geron is closely tied to Janssen Biotech (JNJ Jr.) now, so the "fear-factor" and the financial-factor are significantly reduced.
I think this can all happen soon, since the FDA has no further safety problems (liver holds lifted) on their plate. Dr. Scarlett seems to be working harder to move the PPS upward, now that Janssen in onboard, and the concern about a strong partner, interested in oncology, is behind him. He has been at Stifel, Piper Jaffray, ASH and now JP Morgan health conferences in the last two months. Dr. Tefferi is also presenting as the researcher and academic.
I read the trading channel with a lower boundary of $2.90 and an upper boundary at $3.90, and a middle or wall at $3.40. The FDA approval (no-liver-holds or other safety problems with IMET at this time) should be forthcoming, and cause a breakout to the upside. JNJ has worked very closely with the FDA on numerous medicines, and has global reach beyond the USA. IMET shows promise beyond MF in other cancer, and in combination with other drugs.
The good news about Imetestat is already out (effective, safe, powerful partners, FDA holds lifted). The stock should be at $10. The Washington Post explained why it is not (Sep. 2014). By the end of phase 2 (assuming good results), Geron should be much higher than $10.
Dr. Scarlett would not come to such a conference to be negative. My belief and hope is that the positive information, that he presents, will be enough for the border line potential investors to follow the JNJ lead, and take this company and Imetelstat seriously. We will have to wait for Monday to see if anything that Dr.S says can make a substantial difference on the upside.