Perhaps Black Marango is right on this score that the Geron management despite being paid a million dollar s or hundreds of thousand dollars a piece compensation to handle just a staff of 40 is being grossly overpaid to do their job properly, whereas Tefferi just doing a civil service is doing a much better job I bet without any special compensation!! What are those guys have done beside screwing up the last offering and failing to collect adequate data for the ET and PV trials, making us shareholders suffer heavily both the times?
earfool, what you state above is really what it is in my view also. I have a hunch that the FDA, having recognized internally that Imetelstat is a potential breakthrough candidate for bringing recovery from the hematologic cancers, perhaps wants all loose ends to be straightened so that no one can question it later for granting the Fast track designation. Therefore, it will be only wise for Geron and Mayo to comply to the FDA request expeditiously, honestly and as best as they can do. It won't pay to argue against the query at this point.
I guess (and it's my guess only) that the FDA may have seen Geron's preliminary plan for the proposed MF trial and also looked at the ET/PV trials data and may have got upset with Geron's insensitivity to the low-grade LFT anomaly. Then, may be, it was meant to be a slap on the management's face, because that restriction did not apply to the Mayo trial which also noticed the anomaly. Geron management apparently may have wanted to cut some corners in the cost and may have failed to see what the FDA is looking for. Anyhow, the matter must be resolved apparently soon because Geron still have plenty of time to collect the needed data through their Ph 2 and Ph 3 of all three trials and before license is granted. I think the FDA may be planning to award the Fast Track designation if Geron behaves well and gives satisfactory response and that's what Geron should do.
The issue here apparently is not whether the damage is low-grade or high grade, it's Geron's failure of collecting adequate data from the ET and PV trials and if that is potentially a toxic condition. Perhaps this information is needed for labeling purposes so that the prescribing physician can inform the patient adequately, although it seems odd as the patients using this drug are those on the deathbed and are more concerned about getting rid of cancer rather than being concerned about the liver damage. If Geron trials prove that this low-grade abnormality is reversible upon stoppage of the dosage, it will be the best. I think the hold is just temporary and will be lifted sooner than we presume.
This FDA hold has simply increased gambling in the trading of Geron shares so much so that the the hedgies may have cornered a much larger hold on the shares while throwing off weak longs!!
I think that is what the thinking must be on both sides - Geron as well as the FDA. Hopefully, the FDA will recognize Imetelstat as worthy of the Fast Track designation based on this very thought.
Oh, beaver! how do you do that in a country where lawyers flourish under the excuse of protecting constitutional rights of one individual and not of the society as a whole?!! That's why even a murderer gets away (lack of solid evidence)!!
The SEChas failed to stop the HFT evil!! And, 39.% tax is for higher income guys most of who making that living through decent or constructive/productive means. Slashing 80% tax on short-term trading gains IS the only way to stop turning the securities market into a gambling casino, Black!!
The tax is on GAINS only!! If you have an excessive loss you carryover, Perhaps naive guys like you run into a lot of losses and frequently!! Of course, those computer-aided hedge fund managers can't afford losses and they are much much smarter than you not to pile up losses like you do. If you have been running into frequent losses, it is a lesson you have to take to stop living on just trading and find a decent job and learn how to make your living by sweating!! By the way, I do not think you do your own taxes? And, talking about freedom, I bet, if you area law maker, you will allow drug lords to do their business freely and killers and rapists do what they wish, isn't it?
Excellent idea, Maine!! You have an opportunity. You have to make an effort yourself to satisfy your need, instead of insisting on others doing that. That only will be fair.
Irish, I can not disagree with what you stated above. However, having read a lot of comments in the MPN Forum and communicated with the editor Senyak, it is my opinion that Dr. Tefferi must be careful in not making strong statements against Jakafi's and INFN's role in oncology because both these drugs are licensed by the FDA and are in use extensively. Until the genetic studies unequivocally prove the clear-cut advantage of Imetelstat against these so-called cosmetic drugs should he remain restrained to just telling others how good is Imetelstat without being negative for Jakfi and INFN or such other licensed drugs. I hope you will understand what I mean. Thanks.
tabs, those golden days are gone!! Now, we are living in a modern-day world where computers and internet has changed the face of not the U.S.A. but the entire globe!! Do you know rich Arabs and Chinese and a lot of such other from countries all over the globe can manipulate the NYSE trading? They all have agents do that through their connections to Citi Bank and other global banks like Deutche Bank which also have offices in the NY City!! The simplest way to stop all that nonsense is a simple and heavy short-term gain tax. That will keep all those worms out from manipulating our securities market. We need banks to function and function healthily, but not these worms convert the securities market to a gambling casino. The monkey traders on this board can't just comprehend that because of their short vision.
All that stops if a heavy tax is imposed!! Yes, then, you have to learn to make your living using fair and constructive/productive means, not just gambling. If you want to gamble, there are hundreds of casino's all over the world and now on line!!
Since the conference does not allow pharmas to attend and, of course, the Wall Street dogs will be out also, it has to be a seriously and scientifically purer event unless the Jakafi lobby plants some agents to disrupt what Dr. Tefferi presents because they hate him!! My belief is that there are patients who benefited from use of Jakafi and INFN will raise objections if Dr. Tefferi makes strong statement s against use of Jakafi like he did at the Scripps meeting. Dr. Tefferi, I am sure of being aware of it, may be much more careful at this meeting.
We need a law that requires that lawyers shall not constitute more than one-third members of our Congress and Senate!! Secondly and importantly, political advertising shall be restricted to posters and news papers and magazines; no political advertising shall be allowed, directly or undirectly, on television!! But, the courts will not let both of these happen because the courts are also run by the lawyers!! The lawyers have made life difficult for us and hard-working businesses. We need a constitutional change or a massive public effort to diminish, to just the necessary level, the roll of lawyers in our society. Since that seems like a dream, I can see that we are stuck with this lawyer-dominated country just like the hedgies and monkey- traders infested stock market!!.
The worms seem to have swarmed this board and are out to destruct the quality that was seen in the postings just a month ago and before on this board. I just keep adding busily on the Ignore list; but, the infestation is so severe that, I think, I am going to stop posting until the worms leave!!
I think the current long-term is defined as six months; it used to be a year. Going back to one-year will face a strong politically unsurmountable opposition by funds.
Infestation of our society by these elements is vividly exhibited on this board! Could you have imagined this just 30-40 years ago? It's like our unwise politicians decided to develop an atom bomb in forties despite opposition and warnings from scientists and now even a bankrupt and radically inclined nation like Pakistan has enough bombs to ruin several countries!! The same bloody politicians who wanted to dominate the world by having a bomb, can see a prominent Russian warning just yesterday that Russia has the capability to turn the entire U.S.A. into a radioactive ash!! Not just that, strangely the same politicians now have seen the wisdom some 50 years after the nuclear scientists warned them aspiring to make this world free of atom bombs!! What a foolishness!! And, that same foolishness prevails now in letting the securities market turn globally into a gambling casino which one day the bloody politicians will find to be a threatening cancer of the global society. Greed makes one blind!!
the market and make it a real securities market and not a gambling casino is to institute a 80% tax on short-term gains and leave the current tax for long-term gains. Until our politicians see this wisdom, there will be rampant manipulation of share price and people trying to make their living without sweating will just keep going up like termites of the society and soon our society will be an uncivilized one because living on gambling money will have its repercussion, just like destruction by mafias and now drug lords. It is not only that the banks are allowed to trade and hedge funds allowed to mushroom, it's our politicians' lack of foresight. Prevalence of this mass-scale spirit of making easy money in the society will mean its destruction and the communist system, then, will take over!!