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.
Maine thinks that the liver toxicity question is the main issue, if not the only issue, that is bothering the FDA, and their complete endorsement of Imetelstat. I believe that Imetelstat has been proven safe and effective in the treatment of MF. My conclusion is, that if the FDA still has lingering doubts about liver problems, Dr. T has the data and the "fire-power" to bring them around to his way of thinking. In addition, ASH will be a very good conference for Imetelstat, IMO. Since I have no inside information, my conclusions are based only on public information, and, as Maine would say, are "conjecture", like all investment decisions.
I think your time frame is wrong, but I agree with the rest of you "MODUS OPERANDI". You say, "Imetelstat is headed for Breakthrough Therapy Status, but it will still take a year or two.". I believe that the principle issue was liver toxicity, but that is now a vanishing issue. I haven't had much luck with dates, but all of the positive information will be released at ASH, and some, hopefully, long before.
I believe that Mayo has already put to rest any concerns about liver toxicity, and the FDA is on board with that, with their release of the Mayo hold. Dr. T is getting much more aggressive with his all inclusive position with Imetelstat, and his better relations (science & medicine) with the FDA. The Geron hold is harder to understand, but I don't believe it has anything to do with Imetelstat's safety, effectiveness or quality now. That why I ask others to inform me about: 'What is wrong with Imetelstat?'. If the only concern is, "liver toxicity levels" then Imetelstat approvals must be very close, since Mayo & Dr.T have completely put that subject to rest.
I had asked for medical or scientific reasons to keep Imetelstat off of the market. I have not seen one that is credible. If you have any such reason, please share it with the rest of us.
Dr. Tefferi got the Mayo hold lifted. Now he is in the process of getting the Geron hold lifted. That is what happens when the FDA believes you, and trusts your judgment. Two hats are better than one.
105 days; why is that? No hold needed. It is gone for Mayo under the leadership of Dr. Tefferi. We don't understand why there is a hold in place for Geron. The liver "problems" now seem very minor and unimportant.
Imetelstat is Geron's only viable consideration at the moment. Geron's Scientific Director has left the organization. It appears that Dr. T has filled that vacuum, and is in a position to coordinate all parties. We will see how that works out.