Box, it's all "oil-politics"!! Libya, Syria, Iran, Iraq, Nigeria, Vietnam, Indonesia, and Russia -all oil-producing countries into flames. Who is doing all this? Of course the Saudis and their American friends!! Provide secretly arms and financial aid to rebels and keep the flames going up!!!! This keeps the oil-price high AND knocks down growth rate of huge economies of developing nations like China, Korea, India and even Japan!! Who are the beneficiaries? Figure it out yourself!!!
Despite the news, the biggies continue to manipulate the SP and make tens of thousands a day while day-trading, keeping the SP in the trading range. Means, WS doesn't think the news are good yet. And, I do not think everybody is going to do soul-searching to-night and jump in big to-morrow!!! All eyes will focus on what comes out on 11th. All talk otherwise is just BS.
Why is then Geron's Ph 2 is being held up by the FDA, especially if it allows Mayo to continue Ph 1? In one way or other, the FDA's consent has to be obtained. I do not think Geron can develop Ph 2 plan and begin working on it without the FDA's consent. Yes, the studies may not have to be approved while being conducted; but to say that the plan also does not have to be blessed by the FDA is incomprehensible to me.
Both Huh and Scarlett sold off their clinical stage companies and have no experience in handling a drug past Ph 3 or even take a blockbuster drug through completion of Ph 3. The others in the Geron board are even less experienced. The staff of 40 consists of technicians and junior or mid-level scientists who have no experience in handling a commercial-stage drug. Thus, I see no choice for the management but to join hands with a large pharma which has global sales, manufacturing and distribution capability. In the past, Geron management expressed their idea of subcontracting. I do not think that will work well for Imetelstat as multiple application possibilities for Imetelstat are yet to be investigated along with manufacturing, distribution and sales of Imetelstat for MF including requisite follow-up, testing and monitoring of patients and analyses thereof. Scarlett has shrunk this company to such a small size that these tasks are too much for it. Also, to manage all that, none of the existing executive is adequately qualified. Therefore, earlier a partner is found after Ph 2 is completed, better it will be. And, that may bring in the FTD from the FDA if it's convinced that the drug will be commercialized properly and adequately.
Well, icono, that was my thought some time ago; but, now, Jakafi inhibitors are proving to be a headache for the FDA sympathizer(s), if any. Under that situation, Imetelstat is a covered bright light that needs to be uncovered. I think, the FDA's grant of FTD may very well depend on ability of the management which mishandled ET/PV trials to handle the fast track work. Is the management going to scerw up this multi-center trial or will it handle it well - that is an issue to be considered. What would this management done if Mayo and Tefferi did not do their job? I am not against a very fast track licensing of this product and it must be so. But, the compensation-hungry CEO and takeover-seeking COB (Huh) are not the persons I have trust in doing so..
With a staff of, I bet, mostly of disgruntled 40 or so and compensation-hungry CEO having screwed up the ET/PV trials, do you think Geron is capable of handling the multi-center trial and the aftermath of that? This is a blockbuster drug that will have global demand requiring sufficiently large manufacturing and distribution system. And, additionally, marketing all over the globe and managing all that is not the job these bozos can do!! The company needs a large global player to be a partner or be merged with one.
that the current management has impressed the FDA of its ability of handling success of Imetelstat. In my view, this management has lost its credibility in the eyes of the FDA as evident from the excessive delay we are seeing to lift the hold for even Geron's MF trial. The FDA must have been convinced of the blockbuster (the first of its kind) nature of Imetelstat and would want it to be handled by a more competent partner. And, I believe, unless Geron management, if it's smart, reads this message between the lines from the FDA and convinces the FDA of its clear willingness to establish such a partnership, the FDA may not release its FTD even if it lets it start Ph 2. Partnership with Mayo, which is not a commercial entity, is not enough to accomplish successful marketing of such a product, as this product may bring global leadership and billions of foreign dollars to the USA!! That's the bottom line!!!! I do not think, Irish, you got this, did you?!!
rx7171, I hope only that the current Geron management is capable of taking this Mayo-created glory to proper height and not sell off the gem cheap like it did for the stem-cell assets. The two top guys haven't shown their greedless and shareholder friendly side, if any, to me yet!!!!
Maine, wouldn't all what you say about others not apply to you too? And, your posts really become boring using standard phrases like "brain farts", "cheese-impacted" stuff, " naueseating" , "aliases" and so forth!! Can you find some new ones and some interesting new ideas that are not "nauseating"? Please!!!!!!
I do not think the current management has impressed the FDA of its ability of handling success of Imetelstat. In my view, this management has lost its credibility in the eyes of the FDA as evident from the excessive delay we are seeing to lift the hold for even Geron's MF trial. The FDA must have been convinced of the blockbuster (the first of its kind) nature of Imetelstat and would want it to be handled by a more competent partner. And, I believe, unless Geron management, if it's smart, reads this message between the lines from the FDA and convinces the FDA of its clear willingness to establish such a partnership, the FDA may not release its FTD even if it lets it start Ph 2. Partnership with Mayo, which is not a commercial entity, is not enough to accomplish successful marketing of such a product, as this product may bring global leadership and billions of foreign dollars to the USA!! That's the bottom line!!!! I do not think, Irish, you got this, did you?!!
Well, the FDA's lift will mean that the company is certainly closer to an acquisition or at least partnering by a large pharma as success of Imetelstat is as clear as daylight. The WS biggies will think that, with a staff of only 40 and an inept management, Geron, as is, is just too #$%$ to handle the future of Imetelstat. The lure of Imetelstat success will no doubt bring a rush of several large pharmas to be a partner or seek a merger or simply an acquisition. The FDA will bless this with open hands as it may have been already frustrated with the current management and may then release its coveted prize of FTD or better. Thus, post-lift WILL be an exciting time for shareholders. Therefore, I think, accumulation at this time is a wise step and perhaps that's what smart institutional investors are doing.
The SP still shows serious hesitation on the part of buyers/accumulators!!! Can Scarlett do something to build investor confidence? I would say, yes.
"multipleid..." and "maine...." may be the same person!!! Just look at the language in those posts and note similarity!
Despite the IST transfer, there doesn't seem to be WS enthusiasm about it! Perhaps the FDA's lift of its hold only will be an effective occurrence for the real SP movement; and, the other is my suggestion above!!! The latter will be an expression of "executive confidence" and should have a substantial impact on buyers/accumulators. Hope Scarlett is smart enough to comprehend it!!!
Geron needs to have established manufacturing and distribution facility to supply Imetelstat as and when and where needed. Does any body know if they have done that already? If not, how can they start Ph 2 before establishing that?
If Tefferi is still to remain the principal investigator, the patients will be treated at Mayo, although financing and some of the work may be done by Geron. Remember, it was originally Investigator Sponsored Trial where the Investigator was Mayo, meaning Mayo was footing certain costs. Now, with Tefferi still in charge, I do not know who is going to foot the cost of his personal effort or the time he spends Perhaps still Mayo. These details are not yet known to us and must come out during the CC on 11th. My puzzles are: Why was this done? Who initiated this? Is this done with the FDA's unconditional consent? Until we know answers to these questions, it's hard to predict when the FDA is going to lift the hold on the Geron's Ph 2 trial.
Just for four months? Once this Ph 1 trial completes by January 2015, any future commitments must have been the responsibility of Geron any how!!