Ryan, I can't agree with you that the FDA is unaware of the proposed Geron's Ph 2 trial because 1. Geron must have consulted the FDA prior to the hold to determine protocol and initial planning that has gone on since well before the hold. 2. After the hold, Tefferi himself must have talked to the FDA about expansion of the investigation and, finally, 3 I do not think Geron/Scarlett did not tell the FDA about this plan in their on-going effort to lift the partial hold. By not allowing the partial hold, the FDA is deliberately delaying Geron's Ph 2 MF trial!
Cabo's success and strong probability of multiple applications. The company also is involved in collaborations with several major pharmas. All going on reasonably well. Like Imetelstat, Excel developed Cabozintinib after years of efforts and decided to concentrate on it a couple of years or so back while trimming down efforts on other fronts, having concluded that it will be its wonder drug. In my view, the SP must revert back to $7-$8 level by early 2015 and will go much higher if success in several Cabo trials is attained.
He was hired to look for partnerships for various Geron programs during Okarma's time. Instead, he may have managed to convince the board to divest out of stem cells, have Okarma fired, shrink the company to a one-product oncology-only outfit, get rid of other executives and scientists apparently with an intent to sell it to a large pharma, and place him as the COB!! Before he was taken as the COB, he squeezed $1m compensation for the work he did as a non-board member and as a consultant for a period of less than a year. What really he has done remains a mystery because Geron management never had and has a habit of telling what and why to its shareholders. My understanding as above is based on my reading of what occurred during the last few years or so.
(contd)...Remember that Mayo board had also to approve it. On the other hand, it was purely Scarlett's responsibility to make sure that adequate data is collected during the ET/PV/MM trials, which, apparently, he failed to do. Also, he prematurely declared failures of the solid tumor trial in a way that really hurt Geron's reputation. Furthermore, the BioTime deal he worked up was certainly short-sighted, although the decision to divest from the stem-cell portfolio must have been the board's decision of which he too is a member. Thus, in my view, he has screwed up a lot. If you give $2.3M compensation to be a CEO of a clinical-stage small outfit with only one drug, and nothing else in the pipe line, and which employs only some 40+ personnel, the board should be able to find a much smarter and capable person than Scarlett to take that position. Just look at ACTC in this respect which was able to find a much better replacement as its CEO, and with a much lower compensation than $2.3M!!
Also, Huh, being a physician and one who worked at Sloan-Kettering, has not delivered what he should have. Thus, in my view, Geron management needs changes in case Imetelstat success blows out gloriously to handle all that goes with it at the company. (More later.) Thanks.
There are two aspects of my assessment: 1. Success of Imetelstat as an effective oncologic drug 2. Company management.
On the first aspect, Mayo's findings through its MF trial are solid and show that patients with a certain mutation get either CR or PR while the other may get CI or no significant improvement. Precise study of where and how it's effective must be on-going not just at Mayo but also in other labs & inst'ts. Perhaps all these must also be looking at Geron's data when it developed the drug. This is a tedious scientific process and may take long; but, for clinical applications, all it needs at present is to verify if the drug is likely to bring about cure to critically suffering patients without major side effects or not and if the Benefit:Damage ratio is acceptable or not. Mayo's findings are clear and encourage its clinical usage. Geron's multi-center trial, when in hand, is most likely going to prove the same. Yes, before its actual clinical use, certain limiting conditions will have to be established. But, that will be a part of the trial investigation and research that will be conducted in labs all over the globe. The success of Imetelstat appears now to be certain, if adequate protocols are followed, and is likely a wonder drug because no other drug so far has attained its succeess. And, when, in the future, it is tried, perhaps in combination with other appropriate drugs or medical conditions, its wider applications are very likely. In short, success of this drug is not in doubt.
On the second aspect, Geron's idea of going to Mayo for the MF trial should not have been Scarlett's single-handed decision. It is a policy matter and not an administrative one; i.e., it must be the board decision and not an executive decision. Therefore, Scarlett, an executive, shouldn't be given full credit for that decision, if any, as some suggest on this board. My view is that Tefferi had a lot to do with initiative to begin the MAYO trial. (contd)
nom, a suggestion: Look at EXEL and its prospects for your investment. I am not a pusher for the stock; it's just an honest suggestion. Just keep track of the stock before jumping in.
Maine, just come to senses from your apparently drug-affected mindset of stereotype worthless negative comments, giving no constructive useful comments and responses. If this continues for another day, I will be forced to put you on the Ignore list permanently.
Maine, let me remind you of Will Durrant. He stated in his Story Of Civilization, "One who knows what he knows and knows what he does not know. " The latter part of the phrase is worthy of your close attention!
Maine, no negative news about Imetelstat, just more positive (like chromosome repair for JAK2 mutation cases). The drug is great, but the Geron management is just too short-sighted to handle the success of the drug and must be replaced. Imetelstat success is a credible conjecture, isn't it?
I guess the FDA is looking for establishing specific protocol requirements before oit allows Geron to begin its multi-center trial. Possibility also exists that, if the Mayo study and future multi-center trial convincingly shows solid signs of the breakthrough success of Imetelstat, accelerated approval is down the road. I have no doubt about it now. However, Scarlett must be expelled and someone more capable and having much better foresight should be brought in. Huh also should be replaced from his current position of chairmanship of the board because he has dragged the company too close to WS wolves. Furthermore, the company needs to appoint a board of consultants of well-known figures, including Tefferi. If these three steps are taken, I am sure Imetelstat will take Geron to greater heights. Of course, Scarlett-Huh team is dragging it to a cheap takeover by a large phrama prematurely.
more in your portfolio as the traders and the MM have taken it down this far. Golden days for the shares are not far because Imetelstat's success is sure to be recognized widely at cancer treatment centers sooner than you expected.
Irish, if the success of Imetelstat to repair the chromosome repair is this good, why is the FDA stalling the licensing process? Why is it not allowing Geron to start its Ph 2 with added monitoring/testing for the chromosome-damage improvement along with that for the LFT abnormality? Why the delay? Any thoughts?
Thanks to Scarlett's stupidity of failing to collect adequate data for the LFT issue to save money for testing and monitoring (perhaps to pay for his hefty compensation!)!!!
Also, note that the brochure doesn't mention any other oncology drug!! That, in itself, is a tribute by Mayo to the power of Imetelstat. Of course, the credit shouldn't be given to Scarlett; it should be given to those scientists who worked hard at Geron in the past and were expelled by scarlett! I wonder what must be the feeling of those who were put on the street by this idiot.
Yes, that will be interesting to see!! However, I see no excitement from the Geron side and an enthusiastic optimism from the ACTC front in the meantime. What I mean is that while Geron will give you heartburn, ACTC may elate you for the intervening period!!!
In my view, two phrases are noteworthy in the above; 1. "Scientists yet do not know exact mechanism of action for Imetelstat" and 2. "complete responses (tantamount to a cure) which is almost unheard on in this disease". The first one must be bothering the FDA; and the second one must be their puzzle!! So, the FDA bureaucrats must be scratching their heads and are unable to take an action to allow Geron to begin Ph 2!!