Combination therapies, and the telomere-telomerase fundamentals in almost all cancers, give IMET universal appeal. We know that IMET works well (alone) in several blood cancers (most human data in MF from Mayo Clinic), and the potential is enormous.
The major problem that Geron encountered was about the safety of IMET, and its effects on the liver. With the introduction of Mayo Clinic's data, the liver-holds were lifted (first Mayo's and later Geron's). No other safety issues have been mentioned, so the path to FDA approval seems to be most likely, with the welfare of the blood cancer patients always in mind. If we talk in terms of probabilities, the medical and scientific evidence point towards approval, with a high degree of certainty.
IMET is a blood cancer drug that works, is safe, is unique, and is needed now. IMET and the JNJ-Mayo-Geron partnership team appear to have no opposition speaking medically and scientifically. The hedge funds and other shorts are loosing "steam" and credibility, and are "melting-down", like that famous witch. Patient's needs come first, and the FDA certainly knows that. With JNJ/Janssen and Dr. Tefferi now in charge, all is well.
Black---I think Dr. S's mission was to bring Mayo and Janssen on board, and I believe he will stay around for the IMET coming-out party as a remarkable medicine. The ball is now in JNJ/Janssen's court, and they know how to handle it. 2015 will be an eventful year for IMET and Geron.
At this point in time, Janssen/JNJ controls the "Veil of Silence". There is no (little) question, that they know what they are doing. IMO, there has been an abundance of news from the health conferences, but the investor community has not been listening, and short hedge funds have been in control of the PPS. That is all now changing, but the short hedge funds are in denial. IMET is now safe, effective, needed, life-saving, and unique. The PPS is slowly catching-up, and the benefits of FDA advanced-approval is fully understood by the partners at JNJ. These are interesting times.
My premise has always been that Geron was not capable of filing an acceptable application by themselves, since their data was not adequate. Mayo Clinic conducted the MF trials, and got the results, which were transferred to Geron (all liver holds lifted). JNJ knows how to handle the FDA, which may have been looking to Incyte for guidance. That should all be in the past now, with a proper application on hand at the FDA, and, hopefully, near advanced-approval. Patient's needs come first.
I doubt if that will happen. I would imagine that JNJ has protected themselves in some ways, and probably has the right of first refusal.
It beginning to dawn on the world that Mayo Clinic is the #1 medical research organization, and it only tells the truth. All of their words: tantamount, remarkable, miracle apply to IMET.
Imetelstat is "Tantamount to a Cure". JNJ/Janssen has confirmed that, and the FDA is about to act.
I have never quite understood the difference between "legal short sellers", who have borrowed the stock, and "naked short sellers". I assume both are present, but do both have to buy back the stock?
"GREEN is good!!!"---We don't agree on everything, but we agree on that. Dr. Tefferi seems to be in charge of the IMET projects at Mayo Clinic and Janssen Biotech, which is also good.
JNJ's wealth plus its corporate influence, and Mayo's Clinics results are finally overwhelming the "short-factors". FDA advanced-approval is anticipated. We won't know for sure until the PPS hits $5, and more institutions get involved.
At this point in time, we don't know how effective the telomere-telomerase combination will be in curing cancer, but I think it will be the core medicine in combination with other medicines and treatments. Time will tell.
I don't see anything that can hold Imetelstat (IMET) back, since the telomere-telomerase relationship is so basic to the life of most cells (perhaps all). There are cancers in general, cancer stem cells, immortal cells, and the aging of cells all to be considered. We have already discovered that IMET works by itself, and in combination with other medicines. We have barely touched "the tip of the iceberg", and IMET appears to be a safe medicine. There will be many new discoveries.
The world is learning what, "Tantamount to a Cure" means. That is what Mayo Clinic is shouting from the roofs about Imetelstat, which they also call "a remarkable drug".
It all seems to be coming together. The PPS is beginning to catch-up with Mayo Clinic's pronouncement of "Tantamount to a Cure". Patient's needs come first, and the FDA hears their shouts. JNJ/Janssen are Dr. Tefferi are leading.
IMET has cleared all reasonable hurdles for FDA approval now:
4. possible cures (time factor)
5. life saving
This looks like the short-hedge-funds have been caught off guard. Has the positive data for IMET become so overwhelming, to cause the FDA to act? Something is in the air.