The stock price seems to be reflecting this, but only slightly for now---- "creep"
The trend line is up, as long as Mayo Clinic's results are good. I think that is cast in stone. There is OBVISOUSLY more manipulation in this stock than in most. The random-walks can be ignored, (except by short term traders). The manipulations will be less and less important, as Mayo's medical savvy, strength and skill are recognized. Mayo is not mistaken about Imetelstat, and that is a FACT.
All medical news is upbeat. Geron will continue its upward "creep" until the hold is lifted. Then it will standup and run. The trend line is up, but there will be random-walks across it, since manipulation is not done with yet.
It looks like will continue to creep higher. Remember, the Mayo trials continue with great successes (Irish, for example). They were never involved in the Geron-credibility-hold. Mayo is in control, and Tefferi is trusted.
The Sapphire infusion system should lead to device gains over the next few years. The product has launched in Europe, which should help sales, and the company is looking to transition US Gemstar customers to the device. The consolidation in infusion devices should allow for streamlined operations, ultimately aiding long-term bottom-line expansion. Inflectra should provide some upside over the coming years, as well. It received approval from Health Canada for four indications. As this was launched in Europe during 2013, the top line should grow from a full year of sales.
This "creep" has no negatives. Mayo, I believe, has convinced the FDA that the reasons for the hold (for Geron) has outlived its usefulness. Apparently they had little (or nothing) to do with medical science, and were strictly procedural.
Mayo never had a "FDA-Hold" for patients in their existing studies that were benefitting from Imetestat treatment. That is finally being recognized, as Mayo gathers more and more positive data (CR, PR, CI) without significant side effects.
Thank you for this update. Once again you have shown that the Mayo Clinic trials (with Imetelstat) have been extremely successful. Mayo's trials continue, and the information continues to be world class.
Tefferi is accumulating data, since his studies are continuing. They were NOT put on hold. That in itself is an endorsement. His data is likely good, but could be great. We will soon know.
That the conventional thinking, but I believe you are wrong. Mayo and the FDA are on the same page, since low-order liver observations are not a problem, especially where there is a medical need. Geron is likely to POP this month.
Mayo is the KEY, and the only game in town. It appears that the FDA's partial hold on Mayo will be released first. That will also help Geron. Meanwhile, Mayo continues its clinical trials with patients that are benefitting from Imetelstat. Geron will not start their new trials until 2015. An investment in Geron looks sound, but patience is required. Imetestat may live up to its miracle-drug press.
Repeat The only data that counts, and is in the FDA evaluation, is data obtained by Mayo Clinic in one of its controlled trials. As far as I know, there have been no serious liver incidents in any of Mayo's trials. Mayo and the FDA are the key data takers, and will do the critical analyses.
The only data that counts, and is in the FDA evaluation, is data obtained by Mayo Clinic in one of its controlled trials. As far as I know, there have been no serious liver incidents in any of Mayo's trials. Mayo and the FDA are the key data takers, and will do the critical analyses.
"There seems to be a message here that GERN is less competent and less trusted than the MC. There is a message that the hold is likely to be temporary." (from end2war)
I think this is true. Mayo is trusted by all, while Geron's credibility has been questioned many times (religious right, hESC, leadership, secondary, etc.). Also Geron's stock is constantly manipulated. Geron, without Mayo's support (patients, data), is an unstable organization. Mayo can and will influence the FDA; Geron cannot. Geron will benefit greatly after the temporary-hold is modified.
Whose trials were these? Was Imetelstat a factor? One patient out of how many? Are there any deaths, or serious liver problems in the Mayo Clinic-Imetelstat trials? As far as I can tell, the Mayo trials are free of serious liver problems, and there are no liver related deaths.
Fiddy------: If I knew that, I would have inside information. My guess was May 15, 2014 (Obviously that was wrong). My new guess is very soon, but both Mayo and the FDA seem to be in no hurry, as they try to tie-up all loose ends. Geron is only an observer at this point in time.
Without the continuing positive data from Mayo, Geron ceases to exist. My belief continues to be that the hold is procedural, mostly due to a liver related death (another company; not Geron, not Imetelstat). Mayo knows the truth (their patients and their data). The hold has no reason to continue, and, IMO, is about to be finished with.