When Dr. Scarlett was asked about Geron's future (Piper Jaffray CC), he said that Geron would likely stay in the oncology business, and that the "sons" and "daughters" of IMET (new medicines) would belong to the JNJ/Janssen Biotech-Geron alliance. This indicates that JNJ recognized the potential for this telomere-telomerase drug very early on (shortly after ASH 2013), and got commitments from Dr. Scarlett and Dr. Tefferi, locking out other possible partners. Geron saw the need for a strong committed partner from the beginning.
This all evolved into Dr. Tefferi taking positions at both Mayo Clinic and Geron, and the lifting of the FDA-liver-holds. In the next few days (ASH & beyond) we will find out not only about MF successes, but about other programs that are in progress or are being formed. This could only be done with a partner that wanted to take the lead in oncology, and had the resources to go in any research direction that beckoned. JNJ-Janssen Biotech moved Geron from the "minor leagues" to the "major leagues". We are at the beginning of a long, hopefully very important period in understanding cancer, cancer stemcells, genetics, immortal cells, aging cells, etc., and finding remissions and cures with IMET and related next generation medicines.
The stock trend-line is upward to $5 by the end of the year, and then accelerating when it is open to all institutional investors at $5. This will be a very strange, zigzag path upward, as the short-hedge-funds do their best to hold the PPS in very defined channels. IMET is "too good" for them to succeed.
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
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.
I don't know the date, but there is absolutely every reason for IMET to be fast-tracked. The drug has been proven safe, life saving (100 weeks & still going), effective, unique, and is needed by MF patients immediately. All of the FDA requirements have been met. In addition, the FDA has a giant at their doorstep (JNJ/Janssen Biotech) to reinforce Dr. Tefferi's efforts (Mayo Clinic is the USA's #1 research hospital).
IMET should be fast-tracked, while the calendar still reads 2014, and the FDA is capable of surprises. Few on this board expected the liver-holds to be gone so early on. Fast-track is coming.
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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 news that Geron is now generating is coming fast and furious. Scarlett very cleverly engineered the deal (JNJ-Janssen Biotech) in complete secrecy, and survived the FDA-liver-holds at the same time. 7 PM on Monday will be important, as new paths are defined for the group (JNJ-Mayo-Geron) and IMET. We should see $5 (PPS) next week, as the investment world wakes up.
************MENLO PARK, Calif., December 5, 2014 - Geron Corporation today announced that management will be hosting a live webcast of an analyst and investor meeting at 7:00 p.m. PT on December 8, 2014. John A. Scarlett, M.D., Geron`s President and Chief Executive Officer, will present a company overview and discuss data presented at the 56th American Society of Hematology (ASH) Annual Meeting. In addition, Steven Lane, M.D., an investigator at the Queensland Institute of Medical Research, will discuss his preclinical proof-of-concept data on imetelstat in acute myelogenous leukemia which was published in Cell Stem Cell as well as presented at the 56th ASH Annual Meeting.*****************
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.
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.
There is no doubt left. IMET is a "remarkable" medicine, and even better in combinations apparently. That will be emphasized in 2015 in AML, MDS and MF, plus perhaps some trials that involve solid tumors. No new safety issues have come to the surface, so progress will be unimpeded. A safe drug, obviously, will be sought after by patients and researchers. JNJ has been very wise in making this selection.
The power of the counter market forces (short-hedge-funds for example) is being tested. Can they keep the PPS under $4? IMO, there is too much good news for that to happen, but I have consistently been wrong. The game changers have been: (1) JNJ as a partner, (2) Potential of combination drugs, (3) FDA liver-holds lifted (4) remissions & possible cures. So far the PPS has been held in check, but that is changing now.
We are waiting to see if the FDA will approve IMET (fast track or breakthrough), since safety is no longer a major issue. Of course, safety is always an issue, but, as cancer drugs go, IMET is relatively safe.