I tend to agree with you. JNJ already knows the "IMET story" since the patients, trials, and results are theirs and theirs alone. JNJ is definitely being very quiet, and the question is why. JNJ has already said that they are filing for new approvals on 3 levels: MF (advanced), MDS (low & intermediate risk), MF (frontline, new cases and primary treatment). Are new approvals pending? We don't know.
JNJ has all of the data, trials and analysis for Imetelstat. They continue to tell the world that Imetelstat is both a life saving medicine, and a transformative blood cancer medicine. The Imetelstat safety profile is very good.
This needs to be put into a JNJ press release.
JNJ is to be believed. Imetelstat is a transformative blood cancer medicine meeting all requirements for full approvals. That is yet to be converted into a much higher Geron PPS.
JNJ says, "Our worldwide trials confirm Dr. Tefferi's Mayo Clinic MF trial successes, and extends those successes to MDS". Imetelstat continues to be a blood cancer transformative medicine".
This needs to be put into a press release.
BlackM--We don't know what we don't know. I am hoping that IMET is truly "a resounding medical success" --that is a necessary condition for investors. Otherwise there is no investment. How we ultimately fare is impossible to know, since, as you say, we don't know about special arrangements.
It is JNJ's ballgame. They will decide the future of Imetelstat. The future of Imetelstat is also the future of Geron; they are one of the same. Most on this board appear to believe that IMET is a good medicine (transformative according to JNJ). The unknown and the discussion appears to be around dates; release of information by JNJ and new approvals (FDA & EMA).
As long as Imetelstat's very good safety profile is maintained, new approvals for Imetelstat are guaranteed. Hopefully they will come in 2016.
Janssen secretly applied for and received ODD status. They have likely already applied for advanced and full approvals based upon Tefferi's successes (Mayo & JNJ), patient's immediate needs, and the necessary trial data. JNJ is wealthy and flexible, plus they understand the system.
I don't think so. Janssen (once a separate company; now fully owned by JNJ) is focused on oncology. Imetelstat is a prize jewel, not a "pimple". Tefferi and Grynznov are both part of Janssen to publicize, promote and advance IMET now. Geron is a passive owner, but all important news will come from JNJ (complete control of IMET).
So Blackmarango, you are saying that JNJ knows that they have a very good (perhaps blockbuster medicine) in IMET, but they are "conspiring" to keep the price artificially low. I will take my changes on a very good blood cancer medicine with much potential alone and in combinations. There is too much information and too many people involved to keep secrets much longer.
Slide 45 is irrefutable evidence that JNJ fully supports Imetelstat. JNJ has many irons in the fire, and does fool around with inferior medicines. Imetelstat is "transformative" in the world of cancer.
It sees to me that JNJ is "keeping the lid on" at the request of the FDA and EMA. Hopes run high, perhaps too high, when the praise of an unapproved medicine gets out of hand. On the other hand, Imetelstat has ODD status from both agencies, so those that seek it probably can get it. Something will happen soon (leaks, official?). There is too much data and too many people involved.
JNJ has the information and obviously knows Imetelstat's current status. There are many ways that they can release information (journals, press release, conferences, leaks, etc.). It is amazing that their security is so tight, with so many people involved (patients, friends, care givers, Geron-Mayo-JNJ associates).
You are completely cynical, and wrong. Imetelstat is on the road to new approvals to meet "unmet patients needs".
I don't agree completely. Geron still owns Imetelstat, even though JNJ controls it. JNJ has ever reason to maintain friendly and cordial relations with Dr. S. They are partners.
My guess: JNJ/Janssen was trying to keep "Chippy" functional and involved with a seemly positive announcement about dosing limits. "Market forces" decided (wrongly) that this was negative news.
I would see this as a very late, conservative and unrealistic date date (2018). JNJ has a huge amount of data , results and analysis now, so why should they wait until 2018 when everything is in place for approvals now. The unpublished talks in Sep. 2016 by Tefferi and Grynznov are still a mystery. My guess is that their news was positive. The FDA (by law) cannot deny unmet medical needs (Tefferi at ASCO-2016) in life and death situations (MF & MDS). Imetelstat's full approvals seem inevitable and soon. Why not?
Slide 45 shows JNJ's immediate and complete interest for full IMET approvals now. The blood cancer patients need IMET now. JNJ, the FDA and the EMA have no reason to deny their needs. ASH is not the only outlet for information. ASH abstracts are yet to be announced. This is a quiet period.
JNJ Slide 45 : JNJ is pushing hard for full approvals in 2016 (ASCO to ASH). They are focusing on unmet medical needs (MF, MDS, others). ODD status is in place.
Innovations Across Key Therapeutic Areas
NME (New Molecular Entities, FDA) and LE Filings Planned (2015-2019)
1. MF relapse/refractory
2. MDS low/intermediate risk
3. MF Frontline
Slide 45 (JNJ)--Meaning of NME: New Molecular Entities (US FDA New Drug Approval reports). What does LE mean? Frontline would indicate an Imetelstat endorsement as the one and only effective and safe MF treatment.