There are many reasons a trial patient like this could have died. It's not as simple as stating that the death was caused by Imetelstat. Those who know know that the patient concerned had complications may have been caused, in all probability, by other factors. To say definitively that the patient died squarely because of Imetelstat simply exhibits his/her ignorance and to stick to that belief is mere stupidity.
Yes, all the FDA wants is to get all details (including complications and sequence of events and Geron's evaluation of all that) so that the FDA can dictate appropriate labeling when the drug is licensed and used for clinical purposes because the physician recommending its use has proper warning. This is why the FDA is apparently after the data and evaluation. However, if Geron has already determined that it's terminating its idea of trying Imetelstat for ET/PV, I just wonder why the FDA supposedly would hold Geron's MF trial if Mayo data clearly shows no such serious effect! The FDA certainly can ask for all the data it needs while Geron runs the MF trial!! I think that debate IS on-going. The self-appointed half-knowledged posters on this board are making just unnecessary noise; perhaps, they have an ulterior motive!!!
I have been invested in Geron longer than you!! And, study the science of cell biology before you really understand what I mean! I am not here to teach you the fundamentals of the science!!!
using somatic cells from the ear of an adult buffalo!! The clone weighs 36 kilo and shows no sign of any disease or weakness. Looks like Asteria will be outsmarted by a lot of foreign outfits! Geron is lucky to stick with Imetelstat!!
He has a great job, like my friend a local hardware store manager, managing a staff of 46!! Isn't that a great job to earn $2.3M!! And, nothing to do until the hold is lifted, except taking days off to chase sharks?!! Of course, he makes far less than someone manageing GE!!
The Forbes writer doesn't say what you state here!! What nonsense!!!! Go and ask the FDA and Mayo instead of that guy at Forbes!!!
earfool, is Dr. Padzur going to visit this board to read your post? If not, what is the use of posting this on this board? You should be writing to him directly because you do have a valid comment. Thanks.
End. you area a thoughtful and studious guy; but, your following statement is a bit confusing and contradictory to me:
"The FDA already heard all that for a little over a week and decided to stop GERNs Phase 2 anyway. GERN is not stupid. The partial hold on the MC did not happen without argument and discussion. At that time, the FDA could have told GERN go ahead with your phase 2 ,but they decided not to let that trial get started with another 150 patients till they looked at the liver issue."........
At first you state that the FDA decided to stop Geron's Ph 2 (I think you mean Geron's MF trial); however, later in the paragraph you state that the FDA reversed that but Geron decided not to get the trial started!! Where did you get this information because your statement sounds like you are very definitive about what really went on! On the contrary, to me, Scarlett, in his latest CC, sounded like the FDA may have forced Geron to hold the Ph 2 until Mayo results are out and may not have yet suggested Geron to go ahead with Ph 2!! I am not saying you are wrong, just what you describe is a bit confusing to me.
My belief is that the FDA is upset that Geron ignored giving adequate attention to the LFT issue despite, I believe, agreed upon (but perhaps unclear) protocol for their ET/PV trials. Also, I think that Geron withheld some information w.r#$%$ data on the LFT issue from Tefferi that may have thrown a monkey wrench on Tefferi's work, forcing him to convince the FDA to let him continue on his work through a partial hold on the risk-benefit basis. To me, it sounds like Geron management did some stupid things and we all (including Mayo) are paying for it!! Scarlett's use of word "surprise" pretty much tells me that the Geron management was just too arrogant (and, hence, dumb) until the FDA penalized it for it. If that's not so, it's clearly a Jakafi-lobby influence on the FDA, that could have resulted the complete hold - a delaying tactic.
perhaps until the Asteria hysteria dies down and Scarlett announces something pleasant!! Of course, the stock has been kicked around a lot by these wolves and it needs some rest!!!!
Market apparently did not, despite Asteria shares date of record day!! To me, it means that the big buyers/traders are waiting for action only when the hold is about to be lifted. Until then, nothing seems to be interesting to them!!
You got me wrong, End! I did not mean any doubt about success of Imetelstat. That is easily evident from the CRs and PRs Tefferi got which no other drug got. My concern about Tefferi's silence since he made those remarks is that Geron management may have lacked transparency in providing all information Geron had about the LFT issue to Dr. Tefferi. If so, it would have upset Tefferi. But, for God's sake, please do not read that as my doubt that Tefferi will be a party to cause ANY delay in the grant of Imetelstat license!! Tefferi is a physician and his sincere concern for his patients and service to cancer-sufferers will not let him do that. I have absolutely no doubt about it.
My concern is primarily Geron management's habit of concealing or being inadequately transparent. Any scientifically knowledgeable person will abhor that.
It can't be just him alone, it must be the board also!! One good thing this management has done: Allowed no debt. I hope Imetelstat proves glowing success in much wider applications in the oncology arena than just MF alone.
After he made those bold statements about Jakafi inhibitors v/s Imetelstat and the following criticism of that in the MPN forum and other places, he has been a bit tight-lipped about Imetelstat. OR, is that due to his disappointment with the Geron management for, say, withholding certain information from him about LFT observations in Geron's past-activity data base of which the FDA may have knowledge and not he!!!
w.r.t. the endoderm cells, apparently while Viacyte retaining rights for its gut cells, both parties walked halfway to settle the case. Looks like the BTX/Asteria management is wiser and more productive than Geron's!! Any comments?
Certainly, Okarma is more qualified than Scarlett, who with the company size reduced to a fraction of what it was when Okarma was the CEO, gets more than twice what Okarma was paid!! However, I wonder how Okarma really got his business degree!!! He exhibited no business acumen!! Strange corporate world!!
Even if it's political, it certainly is a lack of management foresight to have ignored long-term effect of a persistent low-grade LFT and its reversibility, especially if you know how to squeeze $2.3M in compensation from an outfit that employs hardly 50 people, isn't it?!!
We felt the same years ago when the share price dropped from high single digit or even double digits for some, to low single digit!!
box, thanks for the complement. But, you know, Scarlett and team has shed off a lot of Geron's valuable assets cheap and wasted efforts in doing oncology trials after shutting down stem-cell work. Yes, concentrating on oncology and cutting down costs may be good from the then financial management of the company was concerned then. But, I am convinced that it is a short-sighted management that lacks foresight needed for a once globally respected research outfit. Okarma and company mismanaged financially; but, Scarlett and company mismanaged intellectually!! We, the shareholders have been unlucky not to see an appropriately smart and faresighted management. If it was, we should never been sitting on our investment that has been shrinking for more than a decade due to lack of any licensed product since inception of the company more than two decades ago, never felt the shock of the complete hold and apparently in the bad book of the FDA.
How can I agree with you if Scarlett knows well how to squeeze $2.3m in annual compensation managing a small research outfit with merely a staff of less than 50 and chasing money-hungry institutions but not its long-waiting shareholders while screwing up the only trials in hand?!!
and building expectations on this board! All that has been simply frustrating. One thing looks clear to me: Geron management screwed up LFT testing in the ET/PV trials and may have not been adequately transparent about the LFT issue to even Mayo or even concealing information about it from Mayo (until Mayo learns it from the FDA!), upsetting both the FDA and Mayo! With only one product in hand and nothing else in pipe line, screws up like these surely doesn't justify $2.3M to Scarlett in annual compensation and 1M share award to "employees" without telling us shareholders why those awards!! That upsets us shareholders!!! Thus, the management has upset all three parties: the FDA, Mayo and us retail shareholders. Getting 60M share voting in favor of this management, apparently from institutions, while we all voted against, is a puzzle I have been wondering about. What is really going on?!!!