I read (can't find link) that remissions can happen as soon as 6 or 7 weeks after the first IMET infusion. Since Janssen is treating patients with IMET, that are no longer being treated by JAK, these MF patients must already be very sick without much hope. Remissions for this group would be quit remarkable. I am wondering if JNJ will also be treating other patients with very early symptoms. Early detection and early treatment of any cancer makes a cure more likely.
Sep. 10th in Boston---JNJ to Present: 2015 Wells Fargo 10th Annual Healthcare Conference. Perhaps there will be some mention of IMET.
The trials are just getting underway, and there is still no news about the first infusion. The PPS should respond to news of the first remission.
We know that JNJ/Janssen is attempting to get IMET approved as a breakthrough therapy for several cancer applications all over the world. The amount of data that they will collect and analyze will be statistically above reproach, and will confirm Mayo Clinic's original successes. The open questions are: When will JNJ see their first MF remission, and will they make that knowledge public?
The investment community does not believe the "stories" that it hears about IMET. Only JNJ's successful worldwide trials will move the PPS to $5. Perhaps a remission early in the trials will do it.
ODD proves that IMET is needed now, and that it is the Best Available Therapy (BAT). The JNJ worldwide trials will answer all other questions.
You are holding JNJ/Janssen, reflected in IMET's Progress and Geron's PPS. This has the potential of a small company with a breakthrough medicine, with the protection of a major drug company with very deep pockets.
To Black****---"Some must doubt that Janssen can duplicate IMET's remissions and safety." I share your frustration and continue to worry about some unknown flaw in IMET's profile that the new trials could reveal. I expect the trials to be successful, but: We don't know, what we don't know. I cannot believe that Mayo is wrong at this late date.
Mayo, JNJ, and the FDA all continue to be very positive about IMET. This speaks to the science, the medical properties and effectiveness of IMET. The Geron PPS is the sum of those properties and many other market factors.
"Tantamount to a Cure" stands and will be confirmed at 65 trial sites by Janssen. That is what the FDA's ODD status already confirms on a limited basis, using the compelling, but statistically marginal, Mayo Clinic data. The length of the telomeres is a fundamental process in all cells, and Imetelstat (IMET) controls that growth in blood cancer cells, and perhaps in cancer stem cells. MF is 1st, MDS is 2nd, AML is 3rd, and all other cancer considerations are 4th on the research time scale.
"Tantamount to a Cure" stands and will be confirmed at 65 trial sites by Janssen. That is what the FDA's ODD status already confirms on a limited basis, using the compelling, but statistically marginal, Mayo Clinic data.
More from MF--Imetelstat bring remissions uniquely
In March of last year, things started to look downright horrific as the company reported that the FDA had placed a hold on the phase 2 clinical trials for imetelstat. Many investors sprinted for the exits, and shares nosedived during the month.
Thankfully, the company managed to survived the potential death blow after the FDA removed the clinical trial hold later in the year. As the trials resumed, the reported clinical results for imetelstat as a treatment of myelofibrosis look quite promising. A pilot study for the treatment showed an overall response rate of 36.4%, which included a complete remission for 12% of the patients in the study.
These results look especially good when compared to the current myelofibrosis treatment Jakafi, marketed by Incyte and Novartis, which has never demonstrated a complete remission in myelofibrosis patients..
Will Geron be the next winner?
If Geron can successfully bring imetelstat to market, it certainly appears to hold huge market potential, as J&J estimates the therapy could provide more than $1 billion in peak sales as a treatment for myelofibrosis alone. If that was to occur, then Geron could reach multi-bagger status from here.
There is certainly a whole lot that could go wrong between now and then, but investors should be somewhat comforted in knowing that a big company like J&J is enough of a believer in this technology to lock up worldwide commercial rights. Plus, the company has only burned about $18 million dollars so far this year, so with $157 million in cash and investments on its balance as of the most recent quarter-end, the company appears to be on solid financial footing.
While this may be a critical turning point in Geron's market history, I'm not yet willing to call the shares a buy, as there is still far too much risk for my liking. However, if the company keeps reporting solid clinical data on imetelstat, I may be willing to open up a small starter position in the company in the near future.
Obviously, he treats it with IMET, since this is Mayo Clinic (Tantamount to a Cure). This could be an important talk for summarizing the progress (ODD, new trials), and general PR.
BAT (Best Available Therapy or Best Available Drug) means that nothing that the FDA knows about is better and safer. In the case of IMET there is no contest because no other drug offers the possibility of remissions or cures (MF and other blood cancers). JNJ, Mayo Clinic and the FDA (ODD status) already know this. In IMET's case the advance from ODD status to full breakthrough and international approval is very close. That is the purpose of 65 worldwide trial locations, as sponsored by JNJ/Janssen.