"John" seems to be model for everything that is positive and promising about Imetelstat. The last line (from Irish) is very encouraging: "Liver function tests all normal: Bilirubin (total and direct or conjugated and unconjugated is normal. ". This would indicate that the " FDA-hold" is about to disappear.
As far as I can tell, for a cancer drug of Imetelstat's power (CR's & PR's), there is very little toxicity (none life threatening) and tremendous promise beyond the current successes. The FDA is just a lagging indicator, but will catch-up.
You are wrong about that. A brilliant Federal Reserve (Bernanke, Yellen) managed us back from the Bush Depression that almost ended the USA economic system, to a more moderate, Great Recession, and, after 5 years, to an ongoing Bull Market In the USA.
Intel started in all with their 4 bit microprocessor. The stock looks far too cheap with new chips and the cloud.
For now I am willing to believe that the FDA is being " very" cautious because Imetelstat is such a huge breakthrough (Nobel Prize, telomeres, cancer-stemcells, etc.). We have all thought conspiracy, but I don't do not think so (at this moment). My belief is that Mayo and the FDA will pleasantly surprise us, in the near future, with joint positive recommendations. What ever problems Imetelstat may have, they seem relatively minor when compared to other treatments.
I have rethought this from the several points of view expressed on this board. I still think its Mayo's game. Mayo is very pro-Imetelstat, and will have the most important say (their patients, their doctors, their data, their trials, their good medical sense).
The FDA is totally dependent on Mayo's clinical trials, their analysis, and their scientific understanding. Geron ceases to exist, if Mayo turns negative about the use of Imetelstat. So far, no one has said that there is anything dangerous (in the relative sense) about the use of this drug. No other drug is in its league (CR, PR, CI, potential cures). The hold is coming off soon. I still think that time period is less than a month. The hold was probably an unnecessary and a poor call by the FDA.
Black--We may possibly be on the same page. They have insured safety (for sure), and perhaps overly insured that. The I's are being dotted, and the T's are being crossed. Many people are involved in this precedent setting review. Bureaucracies take awhile to function, even under the best of circumstances. This process did not start yesterday, and the "hold" has already been in effect for a considerable time. Remember the patients.
Commonsense tells me that the patients' needs trump all other considerations. Mayo has the patients, the "remission-curing data" and all the positive answers. The FDA will give their seal of approval based upon Mayo's inputs, since they do not generate any data. Geron is only the marketing entity, and is dominated by these two greater forces for now.
One back at you: You are very short sighted, and do not have any understanding of the process, plus the common and contrasting interests (Mayo, FDA, Geron, patients, market forces).
The hold will be modified or lifted by May 15. Mayo and the FDA are working together in the best interests of the patients in the Mayo Clinic studies. Both organizations are honest and seek transparency. The conclusion will be that Imetelstat is unique, effective and safe with proper dosing considerations and follow-up testing for possible side-effects. This is based upon available information and commonsense. Geron. of course, will benefit.
FDA support of any kind is an automatic triple to ~$6. You know its coming soon (by May 15), so why fight it.
I think so. FDA has to reason to maintain the hold, unless you believe in conspiracy theories, which, in this case, I do not. I would say "soon" is less than 2 months, but could be at anytime before that.
Only Mayo is a credible source of information from all points of view, at this time. They have no reason to be anything but completely honest and transparent. The FDA will rely on Mayo for all relevant information, good, bad or indifferent. Mayo and the FDA are tied at the hip on this project.
I believe that you are correct. Mayo is on good terms with the FDA. Most likely both institutions will come to the same conclusion: Imetelstat does much more good than harm, and is generally safe. Since Tefferi knows all (about Mayo trials, patients and data), he also knows that the "hold" will be modified, and he has a good idea about the date (very soon most likely). He was very upbeat in Miami.
As far as I can tell, from the information that has filtered forward, the medical community overwelmingly supports Imetelstat as the best treatment available in its class of blood cancer treatments. No new negatives were suggested. There should be complete discussions in the next few days. The FDA hold should be ready for modifications.
I don't have any idea if Tefferi is a fighter or not. I would guess that he would want to get the correct story, as he understands it, out into the public domain. Mayo has been accused of everything, including hiding negative information (liver), hoaxes and frauds. That is obvious nonsense, but there are those that are pushing those ideas. I have even heard that he is an uppity -------, that is seeking to build a reputation as the "telomere-man". It is time for a white-paper. Miami, tomorrow, is as good a place as any. I do believe that he is on good terms with the FDA, and they will come to the same conclusions in the near future (maybe tomorrow).
No reason at all. This is a peculiarity of our antiquated, sometimes corrupt, ambulance chasing legal system. Mayo Clinic data is 100% honest and valid.