The way that I see it, JNJ/Janssen believes that these "multiple trial centers" are the best way to clear up any lingering questions about IMET. There are many questions about the "old Geron's" competence (management, data collection reliability, depth of research staff, financial staying power, FDA relations, etc.). The "old Geron" is reducing staff and slowing disappearing. The "new Geron" or "JNJ Jr." as part of the JNJ "team (Janssen-Mayo-Geron)" is being formed. The structure of the "new Geron" will be influenced globally by the results at the "multiple trial centers", which will start with MF, and go to the whole basket of blood cancer cousins, and beyond.
"Broad Spectrum"---This is the basket of blood cancer cousins (MF, MDS, AML) that may all gain FDA approval, perhaps at the same time.
I believe that you are correct. JNJ/Janssen knows that they have a world-changing-cancer medicine. They are going global with their 24 week trials, with good medical successes likely early in that period. We are all watching.
IMO, the deed is done. JNJ Jr. (alias "new Geron") knows exactly what the FDA wants and needs, and is in the process of fulfilling those requirements. The "old Geron" pushed IMET as far as they could, but they were too small and inexperienced to overcome "the hurtles" by themselves. The 24 week global trials (JNJ/Janssen)will be a confirmation of Mayo Clinic's "Tantamount to a Cure", and will go way beyond that. Imetelstat is getting worldwide exposure, so all of the FDA counterparts will be involved. IMET wants FDA approval, but no longer needs it. I am hoping that the new 24 global week trials will show confirming results early on, and approvals will follow early on.
kpail--We are waiting for the "hedges" to "jettison". So far they have had incredible staying power, and have been able to successfully "channel" their earnings. The true longs should ultimately end up in very good shape, but it hasn't been easy. It looks like JNJ/Janssen and the 24 week trials will finally make IMET a double winner (medical successes & PPS successes).
All looks positive, and the PPS of JNJ Jr. (alias Geron) is sure to follow as the 24 week global trials evolve.
ligas3--This does seem to involve hedge funds, and it doesn't make any sense, as you say. It doesn't seem likely that that IMET will fail or that there will be "bad news" at this point in time. The hedge funds are in trouble.
I believe that the FDA has been on IMET's side, ever since Dr. Tefferi transferred the Mayo-MF data to Geron, to prove the safety of IMET. The ill-conceived liver holds were then lifted, 1st for Mayo and later for Geron. Now Dr. Tefferi's "2nd hat" has been moved from Geron to Janssen, along with the Mayo-MF data.
JNJ/Janssen, with almost unlimited resources and topline credibility, is now starting their 24 week MF global trials to enhance and reinforce what we already know, that IMET is a "remarkable, safe, life saving, remissions bringing, unique" medicine, that is about to revolutionize the way we treat the blood cancer cousins (MF, MDS, AML), and eventually other cancers, alone or in combinations. The FDA will surprise us.
This is obvious to me and you. Why is the rest of the investing world fighting us? JNJ may have the answers with their 24 week trials with IMET, for MF patients that have tried and quit Jakafi. Good results often show up very quickly, using IMET.
The sleeping giant (Janssen/JNJ) is now awake and active. It's representative (Dr. Tefferi), is now in Istanbul, about to speak about IMET, MF, and the basket of blood cancer cousins. It looks like JNJ took a rag-tag-team (unappealing to the investment world), and put it under one roof at Janssen (part of JNJ). The worldwide 24 week IMET trials, for the sickest of MF patients, that have used Jakafi in the past, are now starting.
We will see if Dr. Tefferi and JNJ are going for basket-approval. JNJ may be going for the triple-crown, that is basket approval for the three blood cancer cousins (MF, MDS, AML). There are likely remissions in all three, since they are so closely related. In addition, JNJ has had success combining IMET and one of their own drugs (AML, Australia) .
We will see if Dr. Tefferi and JNJ are going for basket-approval. JNJ may be going for the triple-crown, that is basket approval for the three blood cancer cousins (MF, MDS, AML). There are likely remissions in all three, since they are so closely related. In addition, JNJ has had success combining IMET and one of their own drugs (AML, Australia)
JNJ has finally opened the gates for IMET/Geron investors.
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.