Tomorrow is the day for the CC, with questions and answers. My belief is that all of our timing question will be answered. Some may not like what they hear. I believe we will only get good information about Imetelstat from the continuing trials at Mayo Clinic.
Friday morning should be interesting.
Mayo is the controlling force in understanding the effectiveness and relative safety of Imetelstat. Mayo and the FDA work together on numerous projects. As far as I can tell, Mayo believes in Imetelstat. The FDA holds the "official-government-key" as far as general use (or non-use) in the USA, but Mayo has the knowledge and experience that will make Imetelstat a success (or not a success). That goes beyond the boundaries of the USA, and also into the conference rooms of large-global drug companies.
I still believe that Imetelstat is a good drug and a safe drug. I also believe that it is good investment, but the FDA timing is totally unpredictable. Geron will likely end up with a powerful partner for reasons that have been explored on this board. Only a negative report from Mayo could ruin Geron. That would require a total reversal.
As others have said: There is no bad news, and the hold or Imetelstat will be modified. We have no idea of when. Logic, and sick, dying patients, make me lean toward sooner rather than later. Tefferi is the main factor, and the best source of information.
Geron and The Mayo Clinic Working in Parallel to Release Clinical Hold of Imetelstat (Seeking Alpha--Fri, May 2)----All the information that is needed is in this article. The lifting of the FDA hold is assured (assuming honesty and objectivity, which I believe). My "conjecture" date is still May 15, but that is likely a bit premature. Sidesaddlex: Thanks for those critical paragraphs from the SA article.
You are wrong about that. The Seeking Alpha article (May, 2) is very promising, and is based upon the Geron CC (May 1). In addition, I have complete confidence in Mayo Clinic and their statements.
Geron has struggled with Imetelstat, in spite Mayo Clinic's full support, and a world class drug. They need an affective partner to get this drug into the market place, where it in sorely needed.
From the data that I have seen, there is the a strong statistical probability that some patients that have prepared for "physician-assisted euthanasia" will have remissions or cures. That would obviously also benefit Geron.
Of course it is only temporary. SA article also says you must be in the stock now, because when the hold is modified (as they say) there will be an instant triple. That could happen next week.
It is now obvious that no patient has quit treatments with Imetelstat because of liver problems, and some treatments have continued for more than 3 years (Scarlett & SA). The FDA has been "dutifully cautious" and has no reason to continue the hold in its present form. Mayo Clinic holds the data, patients and good medical sense. Geron, Mayo and the FDA are on the same page, and it all appears good for Imetelstat and the cancer patients.
Sentiment: Strong Buy
MENLO PARK, Calif., May 7, 2014 - Geron Corporation today announced that John Scarlett, M.D., President and Chief Executive Officer, will present an overview of the company at the Bank of America Merrill Lynch 2014 Health Care Conference in Las Vegas, NV. The presentation is scheduled to occur on Thursday, May 15th at 12:40 p.m. Pacific Time.
A live webcast of the presentation will be available through the Investor Relations pages of Geron`s website or at http://www.veracast.com/webcasts/baml/healthcare2014/id83308160094.cfm. Following the live presentation, the webcast will be archived and available for replay at the same address for a period of 30 days
Next Presentation is on May 15. There are NO liver complications, and that will be reinforced.
The FDA has had time to review Mayo's clinical trails, and the long history of Imetelstat safety (3 years plus). The "hold" modification have been drafted, and is undergoing final review. May 15 will bring additional clarification. Mayo, Geron and the FDA are all working together for the benefit to cancer patients. The "instant triple" is coming soon.
There are market mysteries, intrigues and manipulations that have nothing to do with the quality or safety of Imetelstat. Mayo's data is all that counts on the medical side.
Time will tell. As long as Mayo supports Imetelstat and continues with remissions, the FDA will go along. Their job is to review findings, and support patients. Mayo has great influence, and will be heard loud and clear.
Uses of Zinc Today
Zinc is currently the fourth most widely consumed metal in the world after iron, aluminum, and copper. It has strong anticorrosive properties and bonds well with other metals. Consequently, about one-half of the zinc that is produced is used in zinc galvanizing, which is the process of adding thin layers of zinc to iron or steel to prevent rusting.
The next leading use of zinc is as an alloy; the zinc is combined with copper (to form brass) and with other metals to form materials that are used in automobiles, electrical components, and household fixtures. A third significant use of zinc is in the production of zinc oxide (the most important zinc chemical by production volume), which is used in rubber manufacturing and as a protective skin ointment.
Zinc is also important for health. It is a necessary element for the proper growth and development of humans, animals, and plants. The adult human body contains between 2 and 3 grams of zinc, which is the amount needed for the body's enzymes and immune system to function properly. It is also important for taste, smell, and to heal wounds. Trace amounts of zinc occur in many foods, such as oysters, beef, and peanuts.
Each one of these presentations brings new information to the table. "NO liver complications" is very positive. I expect more good news on May 15. Mayo has hit a "home run" with Imetelstat and nothing can change that. The FDA is following along and will make the right decision for the patients, when it is ready.
The FDA "hold" surprised everyone. Now all 3 organizations (Geron, Mayo, FDA) seem to be on the same page. We all know that Geron is a one product company, and that product appears to be effective and safe. Geron would not be making these presentations, unless there was worthwhile, good news to deliver. Mayo is a great medical organization, and is to be believed about Imetelstat's progress. I am very encouraged.
Previous: Each one of these presentations brings new information to the table. "NO liver complications" is very positive. I expect more good news on May 15. Mayo has hit a "home run" with Imetelstat and nothing can change that. The FDA is following along and will make the right decision for the patients, when it is ready.