please sign off My FDA Petiotion by Irish on this goodwill occasion for helping patients suffering from cancer so that they can get Imetelstat to save their lives. Nothing can be a better deed than doing this and asking people around to do this on this day. And, my sincere personal thanks to you all too!
And, if the good news come out on Monday morning, just watch them rushing to cover!! In any case, wouldn't it be fun to watch traders jamming the floor if FDA's lift is announced on a Monday morning @ 9:30 AM!!
Yes, Black, you're right in your statement that members of the law firms may not own any Geron shares. It's clearly a conflict-of-interest issue and a lawyer can loose his/her license. I believe these dozen or so law firms have jumped into this due to some kind of influence of the Jakafi lobby and statements from Dr. Silver who is associated with a NYCIty school (it's either Cornell or NYU). Dr. Silver apparently carries much more weight in the WS world than Dr. Tefferi.
buddy, you must be a Timbuktu-graduate in accounting!! You need to go far beyond your gutter knowledge to evaluate biotechs like EXEL and other new-tech startups. Do you know anything about intellectual wealth and value of patents? If not, you better trade in stocks like Burger King and Walmart. That is where you will do well.
Let me add: Not just shareholders but those suffering from cancers and those who are friends and relatives of these patients must join hands to fight such lobbies by vested interests who are nothing but the tumors of our society.
Please sign the Irish's petition and get hoards of people to sign to fight apparently richly funded lobby. The lobby may have been infested with crooks of WS (including certain law firms) and we, the shareholders, must show them their place.
It means that a lot of Jakafi-lobby brainwashed fund managers exist out there!! The lobby may shower gifts to them and the fund clients will foot the losses! Isn't it wonderful?
Yes, End. Personal letter accompanying and describing personal-experience facts with an emotional touch will make the difference and get attention. We should push more on this board to get the figure to 50 and over; hope most have their own story to add in the note.
Icono, it should be large-pharma and vested-interest lobbies (like the Jakafi lobby) and not politicians directly influencing the FDA. True, if the politicians did not allow the commission having a seat or two for agent(s) of big pharmas, the FDA would have been doing its job right. These agents having the seat(s) in the commission perhaps know exactly who to bribe at the FDA!!!
Yes, you're right, Ryan. I got mixed up.
I really meant that at this time the portfolio managers of certain major funds switch sectors and move into more lucrative opportunities. This time those are perhaps moving into banks and retail stores who will be posting better results for the current quarter whereas the biotech will remain down due to fear of target-price lowering. This is an opportunity grabbed by the others (especially hedgies and HFTraders) who will accumulate biotechs followed by pumping those stocks through paid writers and helped by cooperating MMs. Scared retail holders sell off at a loss, not adequately knowing the fundamentals and playing the market (like my wife tends to do!). These are the people who work hard on two jobs and have hard time meeting expenses, save money (have scant savings), and try to get wealthier by playing the market because the bank savings plans do not offer decent interest. These people do not buy a lot of shares of the same company and do not want to risk their money in high-priced shares like Apple or Amazon and are attracted by the potential for hefty returns from shares like those of biotechs and new-tech companies. They put their savings in such stocks, and watch how their savings grow fast soon after they invest. But, the WS dogs suddenly decide to crash such stokes and these naive guys get out with a loss, afraid of losing everything but get washed out of a hefty chunk of their savings. I know quite a few people like this and pity them. Unfortunately, their zest for getting rich gets crushed due to the game played by WS dogs who want to eat everybody's lunch. That's why I call them "dogs". This wasn't so before HFTs and hedge funds came into being. Thanks to our politicians to let that happen and take away the opportunity of retail investors to be a part of the American dream. I abhor this situation and blame it to HFTraders, hedgies and greedy MMs violating the true spirit of securities investment.
and creating opportunity for WS dogs to accumulate cheap stocks. Then, use fellows at Seeking Alpha to get ready to write great things about the stocks the dogs got cheap and sell those at huge profits. The MMs make money, the dogs make a bundle, the SA pushers get rewards,, the lobbies get richer; but, the poor hard working American trying to make ends meet looses his hard-earned savings trying to make it big in biotech and developing tech stocks. The cycle goes on........ until the poor American guy stands in the unemployment line or seeks the welfare money!!! This is wonderful, isn't it?!!!
This is typical for WS dogs when they want to fatten their portfolios through portfolio rollovers. This happens to selected sectors during Spring every year - a standard WS dogs practice when they realign their portfolios. Biotech stocks are the one sold off now; but, come June or July, these dogs will start singing praises for the biotechs using their media arms and the monkeys will take it back to the stratosphere. Then, come October, the biotechs will become unfavourite again (do not worry, the dogs wll find some excuse (like this time anticipated drug price lowering) and will get sold off. In the meantime, the dogs would have made their killing - monkeys wondering what happened!!!
Rin, I second what Blackmarango states. Please keep posting just as Irish does so that Geron investors and visitors of this board like us benefit. Thanks.
End, you are a respectful thinker and a person who is bent on spending efforts on a thorough study, all attributes of a scientific mind. So, I respect you thoughts and consider them worthy of paying attention.
However, that same bureaucratic FDA who you assume to be sincere has given Fast Track designation to drugs that have been sponsored by big pharmas. You will find this to be true if you search recent-past FDA approval facts. Why? The reason may be that the FDA commission where the large pharmas have their representatives who look out for their interest. Secondly, appointment of the FDA head is approved by politicians. These facts make the organization biased towards vested powerful interests who also have powerful lobby influence. Therefore, I do not consider the FDA to be a purely public-interest outfit. If it was so, in my view, it should not have held up the Geron-sponsored MF trial and help it even accelerate. Instead, it did apparently the opposite.
Regarding the low-grade LFT abnormality, not just the Geron's panel of oncologists/hematologists but also those at Mayo, including Tefferi, did not think it was serious if adequate weight is given to the damage-benefit ratio, especially for the MF trial. For the ET/PV trials, yes; but, those trials could have continued and the needed data could have been easily obtained until the time license was granted which would have taken several years!! And, why would Scarlett express Geron's "surprise" upon learning of the complete hold? Aren't he and Huh both physicians too? Are they less knowledgeable than those at the FDA? Note that Huh worked for several years at Sloan-Kettering and when he also expressed surprise makes me really doubt the sincerity of the FDA action. If you think in those lines, the ill-intended action may be indicative of deliberate delay if the hold is not lifted by say end of May (giving it ~3 months).
And, I am not sure if Tefferi does not have upset some at the FDA and also at Mayo due to his caustic comments on IFN and Jakafi a few weeks or so ago. While Tefferi is greatly respectful for his patients and whatever he is doing for them, he may not carry the same respect among others, especially those who benefited from Jakafi and IFN. This is clear to me when I go through exchange of comments in the MPN Forum. Of course, it's clear to me that the Jakafi lobby is much more powerful than Tefferi and it may have its well-wishers at the FDA.
End, it's wise to be a bit pessimistic in this case than overoptimistic, although I do not mean to say that the hold was justified especially for MF where patients badly need Imetelstat to extend their life. It's simply cruel, and clearly not in accordance with the charter of the FDA, whoever at the FDA thought to postpone the Geron-sponsored MF trial. However, the very fact that that was done means somebody at the FDA must have an ulterior motive. Unless I see the hold lifted by end of May, I will remain suspicious of the FDA's intent. If the FDA wanted to penalize Geron for not giving them the low-grade LFT data, there there were other actions available whereby the waiting patients would not have been hurt. I still think that the FDA's action was not blameless unless it declares its grant of the Fast Track designation along with lifting of the hold.