Too Many Cooks. JNJ, as has been suggested, is calling the shots, and, for now, wants their dealings with the FDA kept secret, until there is a public announcement. The FDA also does not want any leaks, that could cause confusion. This makes sense to me. Dr. S is part of the team (New Geron=JNJ Jr.),
This is a pure guess, based upon my observations. Dr. S got on the wrong side of the FDA with Geron's data collection methods, which centered around the liver problems, which led to the holds, and a collapse of confidence in IMET, Geron and the PPS. They had to get Dr. T, with his meticulous data, to get the liver-holds removed, and, in addition, needed to get Dr. T on the Geron staff (his 2nd job), for increased credibility. Dr. S decided that he could not deal with the FDA, so he is now letting JNJ/Janssen lead the way, and he is doing what every they suggest. Dr. S knew that he needed a complete team with outstanding partners (JNJ & Mayo), and that should be good for both patients and investors. JNJ is still unraveling Dr. S's predicament, but they should be close to a resolution.
"trials"--not "trails"--However all of the "trails" seem to be leading IMET in the right direction for advanced approval.
The trails at Mayo Clinic (MF in humans with Imetelstat) have been successful, beyond anyone's expectations (remissions, safe, effective, needed, unique, potential). That is forever, and cannot be reversed. The FDA knows this and will not deny applications for advanced approval. BlackM**** thinks that these applications have not been made yet. At this point, JNJ would be remiss, but, clearly, I don't know.
Both JNJ and the FDA think about the needs of the patients. JNJ thinks about profit, but they are also aware of and concerned with patients immediate needs. Both the FDA and JNJ are in close contact, so commonsense, IMO, favors advanced-approval very soon. Phase II & III studies will also happen in a timely way, but are different programs.
Compassion is the major reason for granting Imetelstat (IMET) some FDA-advanced-approval-status. JNJ/Janssen is financially strong, with many products, and from that point of view can take their time. The blood cancer patients (MF, AML, MDS--cancer cousins) are in a battle for their lives, and need IMET now. Compassion and good medicine should and does matter to both the FDA and JNJ. Phases II & III can start and continue, after fast track or breakthrough status is granted. That seems reasonable, especially since IMET has passed all of the criteria (safe in humans, effective, unique, needed).
Is the good science and medicine, from Mayo Clinic, finally leaving the short-hedge-funds behind? I am not convinced, but hopeful. The medical success of IMET is a sure thing, because it has already happened.
The success of IMET is already recorded, and cannot be reversed.
The short-hedge-funds are still in control. We will see if they take the stock back to around $3.00 this afternoon. Someday soon, the JNJ/FDA good medicine and good sense reality will catch them off guard.
Anybody: What are the reasons not to grant some sort of advanced FDA approval? It seems to me (if they exist) that there are 2 separate categories : (1) medical, (2) administrative. I see no medical reasons. Administrative reasons would be temporary, with JNJ and Geron getting "on the same page" with the FDA procedure. I believe that they already are there, but I don't know for sure. Can anyone expand on this list, which, IMO, does not have any significance concerning the quality of IMET? FDA advanced approval did not arrive yesterday, so it should arrive tomorrow, IMO.
I don't necessarily disagree with you, about the "Veil of Silence". At this last investors conference in New York, I thought Dr. S. did a good job. He realized, with no questions, that his talk either went over people's heads or he had little credibility. This "Veil of Silence" may not be so easy to penetrate, with JNJ in the best position to get out the message--A Cure for Cancer NOW.
As far as I can tell, there is every reason to grant FDA advanced approval . Imetelstat (IMET) is needed now by patients, is safe, is effective, is proven in humans (MF), has obvious potential in all blood cancer cousins (MF, ET, AML, MDS), and has potential in solid tumors and cancer stem cells. JNJ/Janssen knows all of this and so does the FDA. If JNJ hasn't already applied for approval (possible?), they are now preparing the paper work with Geron. Why would they not ask?
The shorts have this stock in a narrow range around $3.00. This has nothing to do with the safety and effectiveness of IMET. It is fascinating and frustrating that this can happen, The hope is that JNJ's deep-pockets and medical expertise will turn the tide. JNJ-Mayo-Geron form a solid team that is savvy, financially strong, scientifically sound, with medical expertise in oncology.
I see every reason for the FDA to grant approval, but we don't know for sure, if JNJ-Geron has formally asked yet.
Of course that is the fear of all long term investors, that either Geron will "Screw-up" or IMET will turn out to be a "Dud". The involvement of both Mayo Clinic and JNJ/Janssen puts this risk close to zero, IMO, but it is not totally removed. There are no sure things, but every facet that I am aware of, looks good. We are all waiting to hear from the FDA. I suppose this is where we disagree, since you seem to believe that JNJ has not bothered to ask for approval, or even have serious conversations with the FDA. That, IMO, is unlikely, but no one (except insiders) really knows. There is a "Veil of Silence", which is not necessarily bad.
The shorts have this stock in a narrow range around $3.00. This has nothing to do with the safety and effectiveness of Imetelstat. It is fascinating and frustrating that this can happen, The hope is that JNJ's deep-pockets and medical expertise will turn the tide.
The FDA has been very slow, but will eventually do their job. Advanced approval is on the table.
Imetelstat (IMET) is currently successful in MF trails in humans at Mayo Clinic ("Tantamount to a Cure") with full remissions. IMET is the perfect medicine for the advanced approval that the FDA has been advocating (MF, AML, MDS--blood cancer cousins). IMET meets all the criteria: uniqueness, needed in a life threatening disease, safe, proven, no alternatives. Fast track and breakthrough approvals should have happened yesterday. The FDA knows all of this, and JNJ is there to constantly remind them. Approval is coming very soon, since there are no alternatives, and the patients require IMET now. Less
What are you talking about? Imetelstat (IMET) is currently successful in MF trails in humans at Mayo Clinic ("Tantamount to a Cure") with full remissions. IMET is the perfect medicine for advanced approval that the FDA has been advocating (MF, AML, MDS--blood cancer cousins). IMET meets all the criteria: uniqueness, needed in a life threatening disease, safe, proven, no alternatives. Fast track and breakthrough approvals should have happened yesterday. The FDA knows all of this, and JNJ is there to constantly remind them. Approval is coming very soon, since there are no alternatives, and the patients require IMET now.
It seems to me that Geron's PPS is tied to several factors. I believe that they are all "growing", and they could all "bloom" at about the same time. I am very optimistic, but my crystal ball (cloudy as it is) may need some adjustments. It appears to me that IMET's success is "almost" guaranteed, but there are no sure things.
1. FDA approval, with JNJ's help
2. No new negatives
3. Good, honest publicity at the health conferences
4. Short hedge funds see no future, because of the scientific and medical successes.
5. Global trials beyond MF in other blood cancers, and solid tumors