Dr. Scarlett speaks and the investment world criticizes him, Dr. Tefferi speaks and the investment world yawns, JNJ speaks and the investment world takes notice. Geron could not succeed without JNJ/Janssen as a partner and an advocate for IMET. That is obvious.
Investors, in general, have avoided Geron's stock for numerous reasons that have been discussed in detail. Geron is now a JNJ partner, and the IMET team (Janssen-Mayo-Geron) is deep and strong financially, medically, and scientifically. Geron's problems of the past are gone, and IMET's excellent future seems assured. We are all waiting for Dr. Tefferi's presentation in Istanbul, representing the team.
1. IMET has passed every test that it has been given, and Mayo Clinic has shown that it safe and effective in MF (Tantamount to a Cure).
2. JNJ, as a Geron, partner, is setting up global trials to show the "power" of IMET (24 weeks, comparison with Jakafi)
3. The needs of the patients have the top priority for everyone including the FDA and similar organizations worldwide.
4. The basket of blood cancer cousins all appear to be responding sucessfully to IMET (MF, MDS, AML) alone and with combination drugs (including JNJ's own).
I meant "24 week attack". However JNJ and the FDA (plus similar institutions worldwide) are in constant contact, so approval of some sort could come at anytime.
These tests are designed to run 24 weeks, but, I am sure, that JNJ will keep the FDA and similar agencies around the world fully advised of the data and progress. One remission in this group of the sickest MF patients would be significant.
"For the 100th (1,000th?) time... you can only get advanced approval if you ask for it. Geron has not asked for it. Do I know this for an absolute fact? No. But logic is all you need to make a very educated guess."--From Smiggy
1. Geron needed JNJ/Janssen as a partner for its deep pockets, oncology expertise, its ability to go global, and it experience with the FDA. Geron, by itself, was over its head. JNJ is now going "full steam ahead".
2. Geron did not have the influence with the FDA that Incyte/Jakafi had, so the FDA handling of these matters is very unclear, and perhaps unfair to Imetelstat (IMET).
3. JNJ/Janssen, with its 24 week IMET approach, treating the sickest MF patients and former users of Jakafi, is dealing with the (IMET vs. JAK) conflict head on.
4. What ever the problems were at Geron, they are meaningless now, since the team (JNJ/Janssen, Mayo, Geron) is under the control of JNJ.
5. Dr. Tefferi is speaking at an important international health conference (Istanbul) this week, on behalf of the team and IMET. Jakafi days may be numbered, as patients needs will now come 1st. IMET will be the 1st line of treatment, but Jakafi may be useful in combination.
I agree. The results are in and Imetelstat is overwhelming the only choice. Why has IMET not received advanced approval yet? There is something wrong with the process, and perhaps with the FDA. There have been many theories, with some blaming management. JNJ/Janssen is now in charge, so the mistakes of the past will likely be corrected very soon, with the needs of the patients finally coming first.
"Jakafi has never achieved any of these "secondary" Co2+ endpoints. Imetelstat has done so in multiple patients in 24 weeks over the course of 2 years with minimal side effects compared to traditional "chemo" or Jakafi. So, in other words, we will see your spleen shrinkage and raise you a CR+. All in now. May the best drug win."--(from Irish)
Well said. IMET is the odds-on-favorite, and can only lose if it dies before it crosses the finish line (very unlikely).
The answer is obvious. Dr. S and Dr. T have been "Shouting" about IMET (Tantamount to a Cure) from one podium after another, including the bid stage (ASH), but few are listening or believing. That is why Dr. S and Dr. T need JNJ/Janssen, with a "Voice" that all will hear in all parts of the world, and vast experience with the FDA to overcome the influence of others (Incyte & Jakafi, for example).
"Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants With Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With Janus Kinase (JAK) Inhibitor" (Title of the study)--(from posting_clown)
There is a good chance that IMET will be better than JAK on the symptoms, plus we know that JAK does not bring remissions, or a possible cure or chronic condition that is durable. Can JAK enhance IMET in combination, on the symptoms? We don't know at this point in time. IMET appears to be the better medicine by far, so there may be no reason to use JAK at all. Can IMET help those that JAK has failed? This "study" will tell us.
ligas--I am not sure what point that you are trying to make. Janssen is treating patients without any hope. Jakafi may have relieved some symptoms for awhile, but now is useless. If they get remissions with IMET, these patients would be brought back from the dead. JNJ must know that they will likely have some remissions, and others will be helped to a lesser degree. JNJ is trying to establish IMET as the premier blood cancer treatment.
JNJ/Janssen, with the full support of their new associate (Dr. Tefferi, with IMET), is about to minimize Jakafi, by treating the patients that are the sickest MF victims and have also been exposed to Jakafi. This appears to be a 24 day attack, with no prisoners taken. JNJ is going international, and Dr. Tefferi is speaking in Istanbul next week about Imetelstat. Finally, Incyte is being challenged.
The consensus, among those that wish Geron well, is that this stock should be soaring. There are no important safety factors to hold this stock back. The drug works, and the potential is obvious. The FDA seems to be the missing link, and JNJ should have their "blessings" by now. It has to happen soon, with needy patients all over the world.
You are confused. While some of these idiots would take on Geron in isolation, no lawyer in is right mind would take on the JNJ/Geron partnership, with this level of successful medical results, and know-how.
The winners are Imetelstat and Janssen, based upon the science, medical successes, and JNJ very deep pockets plus their experience dealing with the FDA.
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The FDA has confused us all by approving Jakafi (a drug that treats symptoms short term), and ignoring IMET (a safe drug that treats symptoms, provides remissions, and possible cures or at least a chronic state). Now IMET will attempt to offer relief to the sickest of the MF patients. The FDA, I believe, is now in the Janssen camp.
This is the ultimate test for IMET, going for the sickest of the MF patients that have already tried Jakafi and have given up all hope. The team (JNJ/Janssen-Mayo Clinic-Geron) already knows the answer, from Dr. Tefferi's very positive MF trials and studies. Dr. Tefferi will provide additional support to the Bank of America presentation (Dr. S), in Istanbul, next week, as IMET goes global.
This is the ultimate test for IMET, going for the sickest of the MF patients that have already tried Jakafi and have given up all hope. The team (JNJ/Janssen-Mayo Clinic-Geron) already knows the answer, from Dr. Tefferi's very positive MF trials and studies.
You obviously did not hear the speech. Imetelstat is a remarkable medicine. Geron is under JNJ's guidance, and will do very well. The FDA has the data, and is about to act. The new trials will bring IMET to the whole world.