From blackmarango----"lws: you, of all people, should KNOW that IMET is NOT too dangerous to use. If you're dying of MF in a few months, what's the problem with liver damage years down the road???"
Of course, I agree with you. There are no indications, that I am aware of, "that IMET is too dangerous to use". The FDA hold has been discussed ad nauseam. There is no justification for it now (if there ever was), so I suspect it will soon disappear. Don't ask me to define "soon".
ASH has to resolve the remaining issues concerning Imetelstat. Either it is effective and safe, or is too dangerous to use. Geron, as an organization, is too confusing to even think about very much, but the PPS is the "investors-only-game". The medicine, and its future are in the hands of Mayo Clinic, in which I have full trust and confidence. Imetelstat will succeed, but Geron's future is "very-foggy". This is a "miracle-drug" owned by a questionable company. That condition has too change, as Dr. T coordinates both Mayo and Geron trials.
Unless Mayo Clinic is a hoax, Dr. Tefferi is a comedian, and Imetelstat's published successes are frauds, Imetelstat is the real-deal. The PPS of Geron, or its new owner, will benefit, with ASH being a very important milestone. This would type of fraud would have to be a conspiracy at the highest level, so, IMO, it is very unlikely.
"Tantamount to a Cure" means "Equivalent to a Cure". What could be clearer. Mayo is telling us to look at Imetelstat for all of its good properties now (plus potential), as they are as the #1 medical organization in the USA (to be believed and trusted). Imetelstat is a medicine that will be used for MF by Mayo, and in other telomere applications (consider Amgen). There should be a biding war going on, and perhaps Scarlett is conducting one that is not visible to mere mortals (that is the question).
If Imetestat is as good as Mayo says it is, there should be a biding-war going on now. These companies (Amgen, Gilead, Celgene) know about Imetelstat (especially Amgen, that has combined it successfully with its own drug). ASH will reveal all about Imetelstat, and Geron may be absorbed by another by then. Nobody believes that the "Liver-Hold" is a medical-scientific set-back for Mayo Clinic and Imetelstat. Geron is in a great position to negotiate for access to its "miracle drug", which it owns, with Dr. T coordinating all trials. Nothing is guaranteed, but Imetelstat looks like a winner, probably with a new partner or owner in the wings.
There are only three possibilities, using ASH as a time certain.
The Geron hold will be lifted:
1. Before ASH (BA)
2. After ASH (AA)
3. Never at All (NA)
The train has left the station, so all we can do is wait for it to arrive. ASH should answer most, if not all, questions about Imetelstat's future. I think (BA), but many believe otherwise. I am very encouraged by the recent Mayo brochure, that featured Imetelstat.
Maine you are one very sick dude, rude and mentally challenged. You don't have to agree with me, but you can have some reasonable manners, unless you are so far gone that you don't know the difference.
I happen to believe that all holds will be lifted before ASH (BA); others believe after ASH into 2015 (AA), and a third group NEVER. I believe it will be (BA), mostly because of Dr. T's hard work, "two hats", and his extraordinary interest in this project. The small, NEVER group believes that there is something fundamentally wrong or deceptive with Imetelstat. There is no evidence of that, that anyone has suggested.
PREVIOUS ---"The new idea is that Imetestat and Geron can be separated. Dr. T now wears 2 hats (Green for Geron & Mango for Mayo---what color is the combination?). He can coordinate trials under each hat, or combine them when appropriate. The FDA will be presented with the best of both worlds, and the FDA will be happy, happier, happiest."
The belief is that Imetelstat is a good, successful, worthwhile drug, or we have all been deceived. If Imetelstat works and is both safe and effective (a given), then the FDA has every reason to make it available to all MF victims, ASAP. As many have said, there are flaws at Geron (data collection & omissions primarily), but Imetelstat is a great drug. I think, that full clearance by the FDA, will happen before ASH, but obviously, I don't know. As a long term investor, I can wait, unless there has been deception about the quality and viability of Imetelstat (Mayo can be trusted). Someday soon, Geron will have a major partner or be merged out of exsistence; that will move the PPS much higher.
The new idea is that Imetestat and Geron can be separated. Dr, T now wears 2 hats (Green for Geron & Mango for Mayo---what color is the combination?). He can coordinate trials under each hat, or combine them when appropriate. The FDA will be presented with the best of both worlds, and the FDA will be happy, happier, happiest.
This is a Geron problem, not an Imetelstat problem. Imetelstat is an outstanding drug that should not be withheld from MF patients and perhaps beyond. I know that, you know that, Dr. T knows that and the FDA knows that. All will be put right at ASH, and I hope long before. There are "no important negatives" concerning Imetelstat (Mayo trials), and Geron will eventually be forgiven for its transgressions.
You have to separate Imetelstat, the medicine, and Geron, the company. Imetelstat has everything going for it, and Geron cannot get their hold removed. The drug appears to be outstanding, unless all of us are being fooled (seems unlikely). Either Geron is in the FDA "doghouse", or there are major players that we are not aware of (a major drug company, for example), that are perfectly satisfied with the present situation. I buy the argument that the FDA knows this is a great drug, but Geron can't get their act together in a timely manner. Perhaps it doesn't matter in the long run.
All holds are going to go away, and I think sooner (before ASH); others think later (2015); a few think never. There is no way of knowing who is right. It doesn't seem plausible that Dr. T would commit the time, effort, and patients' lives, unless he was fully convinced in Imetelstat's successes and believed in Imetelstat completely.
I guess your job is to destroy Geron, the USA and Obama. You are very good at it, with all sorts of invented, phony information.
"I'd like to see it happen sooner but I seriously doubt it."---from Black**********
Obviously, sooner is better for everyone whose wants good and new medicines for currently untreatable diseases. I think Imetelstat is in that category. Dr. T is working to make this point with the FDA, and also to ask forgiveness for Geron's short comings. My timing abilities have been poor, since I thought all of these problems would have been resolved in July. I still think that they will be resolved at ASH (1st week in Dec.), with enough good news before then to effect the stock very positively. We shall see.
There is no doubt that Imetelstat works, and Geron someday (next month?) will get out of the FDA doghouse. Dr. T is working on that. Then the Big Pharma question will be the #1 consideration. Our old buddy Multiple(ID's) is still full of Shot and All-Space-Debris.
Imetelstat is too good of a drug not be absorbed by a giant. Amgen-Geron or Gilead-Geron still look like good bets to me. It is going to happen, IMO. Mayo will likely have a big voice in this decision.
"Conclusion: Imetelstat's future, and Geron's future may be on different tracks".
I can see that. Geron has a long history with many bumps in the road, and several managements. Imetelstat is Dr. Tefferi's "baby", and he will nurture it with all of his love and skills.
I did say, that I saw and continue to see no reason why Imetelstat is not available to all potential users with MF. I also see Dr. T coordinating the trials and data for both Geron and Mayo, leading to better relations with the FDA. It is not Dr. T's fault that Imetelstat is facing some Geron-hurdles, but he is now in a much better position to address them.
I return the compliment: You are full of Shot and All-Space-Debris.