(from fishermangets)-"I believe the reason is clear: to collect and share information about imetelstat, for myself and others."
If you can create an Imetelstat-website, that filters out the disrupters, shorts, hedge funds, and concentrates on the science and medicine, conferences, etc., you will have done a good service. The effort is appreciated.
JNJ/Janssen has IMET trials and testing well under control. The team (JNJ/Janssen, plus Mayo Clinic, plus Geron) is well equipped to take IMET into any configuration (combination drugs for example), cancer treatment (emphasis on blood cancers for now), and any country that seems promising. The FDA represents one country (USA), but the interest is international. These new trials will remove any lingering questions about IMET, and so far, most of the news is very positive, both medically and scientifically. Patient's needs, IMET as a safe, unique, life-saving cancer medicine, and JNJ's oncology experience are compelling factor's for globally approvals. It has been stated that IMET can show positive results in 6 weeks, after the 3rd dose.
What I am trying to say is that FDA approval is likely to occur soon: "Patient benefits are typically apparent by the third dosage (six weeks after first treatment)." The FDA, before JAK is put out to pasture, wants to make sure that IMET is as good as the "longs" believe that it is. With these integrated, fully developed trials, the first confirming results (perhaps in August, 2015 or before) should bring global approvals, including the FDA. That is what JNJ is aiming for.
Unless someone is hiding some negative news about the safety and effectiveness of IMET (highly unlikely considering the time frame, and the quality of the Mayo trials), the Geron PPS (now a proxy for JNJ Jr.) has to soar as the 24 week tests progress. The telomere-telomerase relationship, as modified by IMET, is fundamental for controlling cancer. JNJ/Janssen is out to establish IMET as the most important medicine for the treatment of blood cancers (1st MF, 2nd MDS, 3rd AML) either alone or in combination. JNJ already has a very good idea about the results. These 24 week trials will yield confirmations of past trails, with much better data. Also they will allow a direct comparison between IMET and JAK.
"Patient benefits are typically apparent by the third dosage (six weeks after first treatment). Patients showing complete remission have shown reversal of fibrosis and even complete molecular response an astounding feat for a drug with patients who had been faced with near term death after other treatment failures."
JNJ/Janssen will be transparent about the progress of the new global, international trials. The FDA, while still one of the most important approval agencies, there are similar agencies in most countries. The FDA may not be the first to grant advanced IMET approval for the treatment of a basket of blood cancers (MF, MDS, AML).
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)