Trump offers new campaign details, predicts ‘massive recession’
In an exclusive interview, the billionaire said he would undo many international agreements. He predicted a “massive recession,” warned Americans against investing in the stock market and offered new details about his potential presidency.
By Bob Woodward and Robert Costa·
2 hours ago (Washington Post)
I believe that JNJ is about to make an important announcement about IMET's progress (hopefully for the better; perhaps at the AACR). Scarlett told us that the JNJ trials were going well. We need someone from the "real" JNJ to tell us that, with details.
They have adopted the Amazon model of building and expanding the business (market share), and not worrying about short term profits.
My premise is that Imetelstat is being supported by a team: Mayo Clinic (world's top, perhaps #1, research hospital, JNJ/Jannsen (world's top, perhaps #1, oncology drug company, Geron (a small research biotech company that realized IMET's potential and brought Mayo and later JNJ into the loop. All three are important, but at this point in time JNJ is carrying the ball through the very complicated approval process that is being carried out worldwide (medical, scientific, legal, applications).
The safety issue is mostly behind us (dosage is always an issue), and observed effectiveness is expanding beyond the blood cancers. JNJ knows all (data, patients and trials) and continues to be fully supportive. JNJ is in charge.
There is no short term correlation between Geron's battered PPS (market driven) and IMET (medical successes), but longer term they will correlate. JNJ is not pulling back. The time is near as the new trial data is collected, analyzed, published, and explained at medical conferences. This quarter (April, May, June) will reveal much of that.
The massive "amount" of IMET information will be statistically significant. That was one of the complaints with the Mayo Clinic data (too small of a sample). The Mayo Clinic trials were good, and I expect similar results from the JNJ trials. They will publish the results (good, bad or indifferent). Considering the expansion of the trials, "good" is the likely outcome. This quarter should be important, as the data starts to flow. The mismatch between Geron's PPS and IMET's successes should begin to correct itself (assuming "good" results).
It totally depends on how important of a medicine IMET becomes. At the moment, I believe that MET will prove to be very successful for many forms of blood cancer, so $10 appears to be too low. The results of the JNJ (MF & MDS) trials should start to appear this quarter. JNJ and Geron certainly have some agreements in place based upon IMET's safety, applications and approvals. JNJ is responsible for everything "IMET" going forward (trials, manufacturing, distribution, etc.).
The JNJ Chronicles about cancer and IMET are yet to be published. They will contain the analyses of the massive about of information that is currently being collected in extensive worldwide trials (blood cancers, solid tumors, combination drugs, cancer vaccines and beyond). The AACR (April 19) will be the basis of one of the early chapters. This information will be an important cornerstone for Joe Biden's "cancer-moonshot". The JNJ-Mayo Clinic-Geron associations will be featured.
This has probably already happened. The final "test" is the results of JNJ worldwide trials. Since they are being expanded, the early data must look good.
We know that the successes of IMET are well documented (also failures, but there are none that we know about). We also know that IMET is part of the cancer-solution, but not the whole solution (cancer treatments, cure and vaccines). JNJ will continue down that path. We also know that Geron's PPS and IMET's successes are not correlated in the short run, so we have no idea what the AACR will bring.
The major question is the "time-factor". I think JNJ is about to give IMET more public support, as the trial data and analyses becomes available. At some point (perhaps AACR, perhaps not) that will translate into a much higher Geron PPS.
Everyone knows that the future of IMET and the future of Geron are both tied very tightly to JNJ's results and analyses of their blood cancer trials (MF, MDS, AML). JNJ will support IMET (and indirectly Geron) at the AACR. JNJ is putting maximum resources into IMET which they see having a role in all cancers (blood cancers 1st) alone or in combinations. There are no significant safety problems, and IMET is effective. That has already been prove. The AACR will be a "coming out party" for the JNJ/IMET team.
"Facts are facts, this is a sub $3 stock with "potential" like many, many, many, many other highly speculative biotechs. The market is forward looking. We all are awaiting clinical trial results. The stock will probably go sideways until then. We are gambling on a long shot. Let's hope the trials work and we make some money and more importantly folks suffering from cancer ARE CURED! "--from shoenfield
The time frame is now very short since the 1st JNJ/MF/IMET infusions were Sep. 16, 2015 (24 week trials). JNJ will finally make an appearance (AACR, Apriil 19, posters 2731 & 2732). The FDA and JNJ are "on-top" of IMET, since ODD status has already given (USA & EU).
Considering everything from Mayo Clinic's successes to JNJ continuing and expanding trials worldwide (about 100--MF, MDS, AML), IMET must be transformative and disease modifying, as JNJ has already said. Facts are facts. JNJ knows the whole story, and controls the patients, trials and analysis. They are the only voice that matters at the moment.
They must believe that JNJ and Mayo Clinic know that IMET is safe, effective, and transformative (tantamount to a cure). Their "sources" are solid.
It is hard to believe that Geron could convince Mayo Clinic to "trial" IMET unless the positive evidence was substainial. It is hard to believe that Mayo Clinic could convince JNJ (Janssen) to "trial" IMET unless the positive evidence was overwhelming. It is hard to believe that JNJ would continue and expand the "multiple-trials" unless they are convinced that IMET is safe, effective, and transformative on several levels (blood cancers 1st--with potential: solid tumors, combination drugs, cancer stem cells, cancer vaccines). JNJ will start to "open-up" at the AACR; it all about JNJ and their IMET trials now.
JNJ is in complete control of IMET (Scarlett said so). As IMET goes, so goes Geron. Scarlett is a very wealthy bystander-advisor with a very large vested interest in IMET's successes. At this point in time, only JNJ's worldwide blood cancer trials matter to long term investors.
"Cancer-Moonshot" works for me. Apollo 11 (1969) was a huge step forward for the USA and mankind, using all of the expertise and knowledge than available. Cancer research and understanding immortal cells, like space, will be a combination of projects that will go on as long as mankind survives. The "moonshot" will be repeated followed by the "mars-shot" and beyond into "god's territory".
IMET is proving itself in the blood cancer universe (ET, MF, MDS, AML, beyond). It's potential is just being realized as a cancer vaccine for solid tumors and cancer-stem-cells. The safety profile is good in all of these situations, as far as I can tell. It is unlikely, considering the time of usage and the number of patients, that there will be any new safety issues, other than adjusting dosages and new combination drug interactions, to worry about. JNJ and the FDA certainly know this.