Black--I thought Scarlett specifically took any "new acquisition" off the table for now. The future is unpredictable after IMET is approved (we hope) worldwide (beyond ODD status) as a transformative drug that is one of the major components in treating, curing and preventing most cancers (moonshot).
JNJ will control and own IMET, based upon "conditions" that we are speculating about. The Geron name may continue as a fully owned subsidiary (Like Janssen), or in some other form, or could vanish. Needham and the AACR are both close, and will say something positive.
There has been observations in the past that when Scarlett spoke the PPS did not respond positively. This time (Needham, Tuesday--April 12) he will be speaking as a lead-in to the AACR (JNJ, Tuesday--April 19). Continuing "steady as she goes news" would be good.
"Everyone tends to discount whatever "Chip" presents. I think it is reasonable to say that his material is reviewed and limited by JNJ, and that he is a spokesman for JNJ now, since they are the only ones continuing IMET trials for blood cancers. I don't believe that he can hurt the IMET franchise, and may have some new information (Tuesday, April 12 at Needham). Then one week later (April 19) comes the posters at AACR (Janssen-JNJ). There is significant interest from all cancer patients and from the numerous worldwide trial sites. Is JNJ ready to support IMET (louder and clearer) in public at this time?" --(previous)
Black---"guess the FDA"
This is an easy one. The FDA (and the EU) are already on JNJ's, the patients', and IMET's side with ODD status. IMET meets all FDA requirements (safety, need, uniqueness, effectiveness). The FDA is required by law to approve this drug, since there is no alternative and it works.
I just can't figure if we are talking days, weeks, or at the latest the end of this quarter (June 31). JNJ and the FDA will decide the date based upon formal filings and the trial data accumulations. There are many reasons to believe that JNJ can reproduce and confirm Mayo Clinic's MF successes. Listen to Needham and the AACR (next 10 days) presentations..
Medically there seems to no reason why the FDA should wait any longer to give IMET advanced approvals beyond the ODD status that they have already granted. Perhaps JNJ wants the "whole ball of wax" now, without any limitations. The IMET safety profile, effectiveness, uniqueness, and the immediate need all seem very positive. Logic points to immediate approvals, but JNJ is being very, very careful. The trial data and results are being gathered as more patients pass the 24 week mark.
Of course there are some "conditions" in place. JNJ has too much invested in all types of their resources (medical, legal, financial, pipeline, oncology leadership, patients and trials, etc.) for it to be otherwise. JNJ took Imetelstat, that had great potential (from Mayo Clinic's limited MF trials), and has backed it completely worldwide on a vast scale. Hopes are high, as we all wait for JNJ to start telling us about their new trials (perhaps starting with the AACR). JNJ controls IMET.
"Chip" has one job, and that is to listen to and support JNJ-Janssen in everyway possible so that IMET gets fully approved international for blood cancers now, and all cancers (alone and in combinations) going forward. Chip said last time: Watch carefully the Janssen trials (Needham follow-up on Tuesday--April 12). This includes the "Cancer-Moonshot", cancer cures and cancer prevention (cancer vaccines).
JNJ is the only organization that has the experience and know-how to get advanced approvals all over the world. Geron is now an important, but junior partner. JNJ knows how the FDA works, and what they need. "Chip's"' claim to fame is the JNJ connection.
Everyone tends to discount whatever "Chip" presents. I think it is reasonable to say that his material is reviewed and limited by JNJ, and that he is a spokesman for JNJ now, since they are the only ones continuing IMET trials for blood cancers. I don't believe that he can hurt the IMET franchise, and may have some new information (Tuesday, April 12 at Needham). Then one week later (April 19) comes the posters at AACR (Janssen-JNJ). There is significant interest from all cancer patients and from the numerous worldwide trial sites. Is JNJ ready to support IMET (louder and clearer) in public at this time?
I think most of the world, when they hear about "a cure for cancer" or even a major advance in the treatment, think "snake-oil". IMET needs loud, clear and unambiguous pronouncements (from JNJ) to evaluate IMET (from snake-oil to an important cancer-transformative-medicine). We will see if the AACR is a start. The evidence is mounting in IMET's favor, but the jury is still out.
There has always been speculation of a spun-off Janssen as the premier oncology company, with a "blockbuster" Imetelstat, Geron would be absorbed. Janssen once was independent. JNJ is so large now, that a spinoff would make sense.
"Janssen Pharmaceuticals offers a wide range of therapeutics, including products for attention deficit hyperactivity disorder (ADHD), general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. A US-based arm of Johnson & Johnson's global pharmaceuticals segment, the company's offerings include Risperdal for schizophrenia, anti-infective Levaquin, ADHD drug Concerta, pain medicine Nucynta, and contraceptive Ortho Evra. "
JNJ will control IMET. The question is how will they do that and what is IMET worth as a critical part (telomere length & enzyme telomerase considerations) of the treatment and cure of all cancers (blood cancers first--then cancer vaccines and beyond). JNJ may already have what they want. If IMET is the "missing link" in the Cancer-Moonshot (listen to Needham and AACR) then IMET is worth several fold the current price. Is there a good reason for JNJ not to absorb Geron (with good to outstanding results from their worldwide trials)?
Remember that Needham is a lead-in to the AACR (JNJ), and "Chippy" releases only the information that JNJ scripts for him. IMET is very important to JNJ, and JNJ is the senior partner.
We are all starved for information about the numerous worldwide JNJ-IMET trials. Will Needham (April 12) and the AACR (April 19) give us a down-payment about progress and potential? I certainly hope so. All we can do is listen and draw our own conclusions.
JNJ is now the decisive factor with full control of IMET: patients, trials, Geron, and business plans. April 12 (Needham--Geron) and April 19 (AACR--JNJ) are dates to watch. JNJ will ultimately win the "Tug of War". The safety factor is resolved, so we only have to deal with IMET's successes (improvements, remissions, cures, combinations, vaccines, etc.).
JNJ is the only organization that has the whole IMET picture from the Mayo Clinic trials to the ongoing, worldwide new trials. As Scarlett said, follow the new JNJ/Janssen trials. They are responsible for the patients and the distribution of IMET. They are the only group with the information going forward. When JNJ speaks, the world will listen.
Black--Perhaps they are expanding their capabilities to explore all aspects of all cancers (blood cancers first) since telomere length and the enzyme telomerase appear to be a factor in almost all cancers. This looks like JNJ's contribution to the "Cancer-Moonshot". There is so much new material now about cancer vaccines and cancer stem cells that involve IMET.
I think everyone agrees that IMET's future depends upon what JNJ says about their trials. I don't know how much of that information will be available by AACR. There is no way to separate IMET's future from Geron's future.
This is so simple and so obvious. JNJ already knew that they had a winner with IMET from the very carefully completed and successful IMET trials at Mayo Clinic. Now they are pushing IMET to the limit (new scientific analysis, around 100 new trials). JNJ is very rational and conservative. They have all of the patients, trials and results, so they cannot be wrong. They have called IMET a transformative and a platform cancer medicine (alone and in combinations).
BlackM--One way to look at it is that the minimum number of patients would be 40 (only if trials are doing poorly). If the trials are doing well, which seems to be the case, the-more-the-merrier (for statistically completeness, patient's welfare, researchers confidence). ODD status (granted in the USA and the EU) gives JNJ/Janssen complete leeway on where and how the trials are to be conducted (in consultation with the FDA and similar international agencies, so that all are satisfied with the conclusions).
Kasick is by far the most qualified, true, long term Republican still standing, without an acid-insulting personality. Trump is smart, but insane--a very dangerous mixture.