Well, I already have informed Senator Dianne Feinstein to prod the FDA after talking to Dr. Scarlett or Dr. Huh and Dr. Tefferi. Hope she indulges herself to straighten the matter, if the FDA is playing any game or is well-intended to clarify this LFT matter prior to granting the Fast Track status. Her indulgence will make the difference and provide a slap on the face of Jakafi well-wishers if they are playing any games.
beaver, I think it was Scarlett's and Huh's misjudgment that collection of full data on the persistent low-grade LFT will not be demanded by the FDA and was unnecessary. Perhaps it wasn't a mistake; but a judgment that the guys at the FDA may be using to slap Geron. To me, it looks more like the FDA ploy to deliberately delay inevitable licensing of Imetelstat so that their Jakafi friends can shovel billions more.
Those who sold off must be regretting!! And, the WS dogs want more to sell based on their media propaganda and analyst downgrades so that these dogs can capture more cheaply. It will be simply foolish on part of long shareholders to give up their shares at this point.
of this price drop caused by its own lack of foresight in collecting the LFT data as any options it will award to themselves now will be priced much much lower than if the SP had stayed above $5!!! The management reaps benefits even if it screws up; but, we, the shareholders, get hacked!!! What a system these corporate dogs have created to fulfill their greed?
It is noteworthy that the FDA restriction of administering Imetelstat to all patient applies ONLY to all "Geron-sponsored" trials, not that of Mayo's MF IST!! That means Mayo has been collecting the LFT data adequately; but, apparently Geron is not!! Then this is a slap in Geron's face, not in Mayo's. Geron did ignore taking the data in adequate detail! But, it doesn't mean Imetelstat has failed. These are important differences between the reality and general public misunderstanding to keep in mind.
Excellent argument, jack!! The FDA is not that stupid to see that because they deal with licensing of all drugs and know it well; it's the issue in the fertile(!) brains of Jakafi well-wishers and some self-appointed half-baked pundits who think it's their pious duty to come up with such reasons (no matter how stupid really those are!!).
Dear, Ph 2 is not even started. The FDA will have plenty of time during Ph 2 and then Ph 3 which will take several years to collect the data as it wishes!! Why is the FDA and you are so concerned about it now? Do you think the doctors at Mayo and Geron's own staff and experts want to kill people? The patients need approval of Imetelstat as expeditiously as possible so that thousands of dying patients all over the globe can be helped. Leave the issue of the low-grade liver problem to patients and their physicians to decide, just like they do now, for chemotherapy and even Lipitor users!! There seems to be no reason for the incomprehensible FDA action now unless it is in bed with the Jakafi lobby!! I do not see any other reason unless it is well-intended to straighten this issue prior to its already inner-circle predetermination of granting the Geron's MF trial a fast-track status soon after resolution of this issue so that Geron's Ph 2 and Ph 3 can be planned now to be combined. I see that being a strong possibility. However, to squeeze that from the FDA, we, the shareholders, and the patients must make enough noise for the incomprehensibility of the action to halt the trials at this time!!
Do you see my view now?
Black, a CEO is just an executive/administrative head. To get help from a big pharma is a policy issue and that is taken by the board of which the Chairman is Dr. Huh. But, even Huh can not impose his will if his view is in a minority in the board. Just understand the process before keep blaming Scarlett for everything. Of course, I am not a great Scarlett admirer and also believe that a lot of such issues faced by Geron will disappear if it's a part of a big pharma with wide shoulders, However, in that case, it is my view that the board must have decided that it will not serve the best interest of Geron shareholders if such a merger is done now during Ph 2 and be done best in Ph 3. For that reason, the board may have decided to raise the cash level from $50M to $150M. All that is NOT Scarlett's baby!! Yes, it's Scarlett's responsibility to handle FDA issues and expedite response to the latest inquiry.
Ask the patients!! And, Jakafi that doesn't cure, isn't cheap!! So, ask the insurance companies if they would prefer paying for Jakafi if a better alternative is available soon!!
lovr, do you hold a lot of Incyte shares? OR do you belong to the Jakafi lobby? Whatever it's, you sound like you do not read all good posts and do not understand the entire issue. Please, try to educate yourself well before becoming a devil's advocate. Thanks.
First of all, thee statement was made before any written word from the FDA was received. So far, we have no word if that is received by now or not. If it's not received, it's possible that that verbal message by someone at the FDA may have been going through some soul-searching OR, the FDA, under the guns from patients and politicians and lawyers (attempting to bring the whole matter in light that may require the FDA to explain its action), must be taking time to prepare the written notice with extreme care. Remember, if Senator Dianne Feinstein and Barbara Boxer find out that the FDA is unreasonably harsh with their Northern California outfit, especially for just a low-grade persistent LFT abnormality observed in some (and not all) of the patients and which has not been considered serious by physicians and experts at Geron as well as those at Mayo Clinic, the world-famous and top cancer research and treatment facility, the people at the FDA who are responsible for bringing up this issue at this time and impose a full halt on the trials will be wetting their pants!!
Furthemore, it is incomprehensible to me that the FDA is delaying licensing of a "breakthrough" drug for a low-grade LFT abnormality for patients who are going to die anyhow within a few months to hardly a few years without Imetelstat when drugs like Lipitor licensed by the same FDA, causing acute level liver damage, is allowed; and, allowed for patients who have a very long life to live relative to those suffering from the deadly cancers. Isn't that different than Lipitor situation? Then, why did the FDA allowed Lipitor and is foot-dragging licensing of Imetelstat which is still to begin Ph 2 and will have plenty of time, years, before Ph 3 is completed and license given, to resolve the bloody monor issue!! Can you imagine how many thousands will die all over the globe if licensing of Imetelstat is delayed by just a few months?
red_bull, you are acting like you are one of those Jakafi-lobby guy!! Just look at the explanation in appropriate scientific and authentic documents to see why Dr. Tefferi or others at Geron did not consider this to be a serious problem!! Are you more knowledgeable than Tefferi who tried this drug on many patients and studied the side effects deeply? Do not loose sight of the fact that this drug is the first known life-saving drug for DYING cancer patients and not those Lipitor or Tylenol users who will live much much longer!! Use your common sense before becoming a devils' advocate, please!!
Thanks, spectro. You and paldridge are the only one with good comments so far; of course I see five thumbs up and one down! Well, in a democracy, the power of people doesn't work if people remain subdued or silent.
MLV guys are bunch of WS guys who live only in the WS world and have very little outside knowledge or even common sense. They do not understand the power of patients and lawyers. When these #$%$ find that there are other factors that will force the FDA to speedup the process, they will tell their client to buy Geron. They flip-flop often like that!!
Perhaps a certain restricted word if not a link! I did not type the entire link and just a part of it and yet was not allowed until I removed that and deliberately misspelled or played such other trick.
Yes, Black, I read that post from Irish day before yesterday. I believe that the FDA can not stop patients already taking Imetelstat treatment and corresponding studies being performed. My understanding is that the FDA asked Geron (and also perhaps Mayo) to stop admitting any more new patients. This clarification is not sought by any questioner from Scarlett during the CC. However, in my view, the FDA can not dare to stop any on-going treatment because if it does so and a patient dies, it will be subject to a lawsuit. Thus, the FDA action, in my view, to stop any actively recruiting trial is simply meant to delay the process. Whether their intent is good (in case it wants to clarify sticking points prior to a fast-track approval) or bad (just knit-picking), I am just assuming at this point that it's the latter based on the Jakafi lobby's propaganda all over the media, including the MPN Forum and scientific gatherings and journals (like the one by Dr. Silverman from NY City).