You missed the point. The decision maker is Mayo, and Geron is following along. Mayo has the FDA well in hand with all of the critical and necessary information.
From Black---"One of the problems that ALL investors have is that the GERN - Mayo relationship is just NOT clear. Who controls what and how? Details are missing and our dear leader is reluctant to tell us!!!"
I think you may have hit on a critical point. Imetelstat's successes have exceeded everyone's expectations. Mayo tried this drug with little hope of a breakthrough, but they got one, to everybody's surprise (including Geron, Mayo, Incyte, FDA, etc.). I am guessing that when Mayo takes on "a last hope experimental drug" they take full control. Geron is the company, but Mayo, IMO, is the decision maker with special benefits. Mayo, IMO, is in control. Mayo is Geron's savior, and is on top of the FDA, IMO.
Scarlett was brought on board to sell Geron, but he ended up with caviar, not old-sausage. The game plan radically changed; to what is not clear.
Others have deep pockets, but this is a good fit. Gilead wants to prepare its pipeline for the next 10 years.
I think the discussions are between Mayo (data, patients, trials, follow-ups, medical smarts) and the FDA (hold, politics, approvals). Geron and Scarlett are barely in the loop. The hold probably has outlived its usefulness (if it ever had any), and could be removed or modified at anytime (next week, next month, longer). Also, Colorado is now in the game, and could make their own arrangements with Mayo, if the FDA continues to drag its feet.
I believe you are correct. This is your key line: "The Mayo Clinic is seeing never before seen results with GERN's cancer drug.". Imetelstat still has its miracle-drug status, but that has been tarnished by Geron and the FDA. I believe the original luster will return soon. We shall see.
Geron has very little credibility, and that has spilled over to Mayo. This is a Mayo Clinic program (Imetelstat---CR, PR, CI), but they do not get the proper high-marks for their successes. Geron is the "black sheep" in this family, but I believe that Mayo's good work will prevail eventually.
I don't think that I am being a "cheerleader". There are risks: (1) Mayo may be proved to be incompetent; (2) Geron may prove to be corrupt; (3) Imetelstat may prove to be deadly dangerous; (4) Market forces may bankrupt this company; (5) FDA may never lift the hold.
I think I have covered most of the reasons why this stock appears to be so very cheap. My belief is that Imetelstat is a safe, effective drug. Obviously, most people disagree, as reflected by the low stock price. So, it appears that I am a contrarian. On the other hand, some people buy straw hats in the winter.
Conclusion: I put this risk as close to 0% as possible. The science and the medical successes all appear to be positive. The price of the stock (until now) has been held close to $2 by market manipulations of questionable legality, plus an FDA hold of questionable wisdom and unknown duration. At this point in time, from all that has been published, it appears that Imetelstat is sufficiently safe and uniquely effective. Does anyone question this conclusion?
There does not appear to be any reason not to accumulate the stock as a longer term investment. I would like to hear the negatives that I may not be considering (if any).
Blood Cancer is the reason for the new law. I have not found a specific reference to Imetelstat, but that likely is the drug of interest (brother of state senator that introduced the bill). Colorado will start to give limited approvals, and will not need FDA approval (state's rights). I would hope that Imetelstat will get a needed boost here.
Previous###. Imetelstat still has its miracle-drug status, and the full support of Mayo Clinic. There seems to be no evidence to contradict the positive results that have come from the continuing Mayo trials, but there is much to be learned. Telomere research and its links to genetic science are a key part of the 21st century medical universe (the next 85 years and beyond). This is just the beginning. The FDA-hold seems to be ready for modification, since there is no apparent reason to keep it in place as it is. Colorado's interest in blood cancer patients (the case behind the new law) will influence the process.###
It seems to me that this is a "bet" with a high probability of success. I hesitate to buy more because I do not understand the market control that can pull this stock back to $2 over and over again. I think there will be a break out to the upside, but who knows. The more one believes, the more one can be disappointed.
Colorado has based its new Right-to-Try-Law on the failure of the FDA to recognize the needs of certain patients for drugs that look very promising. The center of attention is blood cancers, which certainly involves Imetelstat. Mayo recommends this drug, and the FDA "hold" is mostly procedural (not scientific). The "hold" is on its way out, because the FDA will not politically take on the State of Colorado over a curious, questionable "hold".
Mayo medical science is the enviable dominate force here. The market gyrations are short term reactions to a controlled market that seems to be able to hold the stock around $2. One day soon that control will end.
These are two more reasons to be optimistic about Imetelstat. The #1 reason is the continuing positive news that comes from Mayo Clinic about remissions and cures. Continuing strong science and strong medicine from Mayo means that the hold will soon be gone. The FDA has their own time table. Perhaps the people in Colorado that get them to move faster.
This puts the Imetelstat story into the proper perspective. The Mayo Clinic's current beneficial results and the future possibilities are beautifully summarized for everyone to appreciate. Thank you for this letter.
From New Seeking Alpha article (May 20):
#### Hence, the hold is more of a procedural or a point-of-order call, and much more so than a scientific statement or a hint of the efficacy of Imetelstat.
If anything, the additional scientific information we received from Mayo Clinic was that Imetelstat, Geron's medicine, should be an integral part of addressing certain class of myeloid disorders. Additionally, the latest company presentation (the 2014 Bank of America Merrill Lynch Health Care Conference) seems to have restarted the same pre-FDA-hold enthusiasm. ####
Of course this (Tefferi quote) is the operative statement. Imetelstat still has its miracle-drug status, and the full support of Mayo Clinic. There seems to be no evidence to contradict the positive results that have come from the continuing Mayo trials, but there is much to be learned. Telomere research and its links to genetic science are a key part of the 21st century medical universe (the next 85 years and beyond). This is just the beginning. The FDA-hold seems to be ready for modification, since there is no apparent reason to keep it in place as it is. Colorado's interest in blood cancer patients (the case behind the new law) will influence the process.
It is hard to understand the current hold (liver low-level sightings), that are non-life threatening. The new Colorado law may have an impact here. The FDA is understaffed and underfunded. Mayo, with all the proper tools and knowledge, is pointing in the right direction to prolong and, in some cases, to save lives where there is no hope left.
The FDA no longer has complete control for the use of experimental drugs. Imetelstat seems to be in the "poster-child" position for use in the appropriate states (Colorado for example) as a safe, effective drug that can save life.
PREVIOUS NOTE: The "experimental treatment" mentioned for "a rare blood cancer" could very well be Imetelstat. Imetelstat, because of its safety and effectiveness, will likely be the "poster child" of the "Colorado-step-into the future of medicine". Joann Ginal and Irish are champions of the cause. Imetelstat has a growing list of supporters including Mayo Clinic on the medical side, and the state of Colorado on the political side.
Obviously the hold is still in place, but Mayo is still on the job. According to Seeking Alpha (May 2 article) Mayo and Geron are both working to lift the hold. I still think that will happen soon, because I have 100% confidence in Mayo Clinic. There are no good reasons to maintain the hold, that I can see. More data is being accumulated by Mayo (CR's, PR's, CI's, potential cures). Seeking Alpha expects the hold to be lifted without any fanfare at anytime now, so, I believe, one should maintain a core investment. Also, the coming "Right to Try" laws in the states work in Imetelstat's favor.