I do not see how the PPS can be held down with so much good news and obvious potential concerning IMET (ODD, JNJ, etc.).
" However, imetelstat, according to science literature takes on long and short telomeres in cancer stem cells and could be used as an adjuvant to other cancer treatments, and that's big." (from jackdaw605)
I am a retired non-biological scientist, so this telomere-science is new to me. You are preaching to the choir about the universal use IMET in all telomere sensitive cancers, with the blood cancer cousins first in line, followed by solid tumors and cancer stem cells. That is JNJ/Janssen's goal.
jackdaw605--I will be the first to admit that I,"--still don't get it". I don't claim to understand telomere-science. I thought the object was generaly to shorten the telomeres, and stunt the grow cancer cells. I think you are making a statement about the initial size of the telomeres, but I don't get the significance. Could you please expand that thought.
The only explanation is that there is a general belief by "dominant" investors that Imetelstat ultimately will fail, and Geron will collapse. The evidence points in the other direction, as far as I can tell (ODD approval and JNJ partner).
Have the shorts given-up in the face of overwhelming evidence that IMET is safe and effective?
"First, because telomere shortening and consequential tumor growth inhibition require many cell divisions, single-agent telomerase inhibitors require substantial time to significantly decrease tumor growth. Second, telomerase inhibition typically results in only a cytostatic effect, which allows tumor cells to acquire secondary genetic and epigenetic alterations resulting in drug resistance. Finally, single- agent telomerase therapeutics often fail due to activation of ALT pathways, which bypasses the requirement for telomerase." (previously presented on this board)
JNJ/Janssen partnered with Geron because "telomere shortening" is fundamental for remissions and possible cures for assorted cancers. The road to a cure seems to combine other medicines with IMET, although MF has been tamed with IMET alone (to date). JNJ has combined one of its own drugs (Doxorubicin) with IMET to treat AML (an MF blood cancer cousin). The last that I heard, those studies were happening in Australia with considerable promise. It appears that IMET, in combination with other drugs, becomes a more powerful force. The cure for cancer will involve IMET, but not as a "single-agent". Each form of cancer will involve telomere-shortening, plus some other treatment, for optimum results. There is much to be learned.
The 36 new JNJ global trial sites will be trying to answer that question. The fact that IMET brings about remissions at all is surprising, and tied somehow to "telomere-science". However, that begs the question of why some people get remissions, some partial remissions, some significant improvements, and some stabilization. I read a statement, that I cannot verify, that about 80% of MF patients benefit from IMET. These new trials will establish markers and indicators, that will increase the understanding of the science.
The 36 global trials should tell more about why some MF patients have remissions, and others do not. There is a complete science of markers and indicators, that is yet to be developed, around IMET and telomere length.
Everyone is watching and waiting for new data and new information. There seems to be only good news about Imetelstat. A question, that all researchers are trying to resolve, is, "Why doesn't IMET work for all MF patients?". Telomere length is a critical factor in most cancers (90%) and is particular effective in blood cancers. IMET seems to be beneficial to about 80% of MF victims, but not all have remissions. There is still much to learn, and the next 24 weeks will be a massive learning experience all over the world.
JNJ would not be sponsoring 36+ trials internationally, unless they had Imetelstat under complete control, both medically and financially. INCY probably does has the most to lose. A JNJ buyout of INCY may make some sense, if they can get it at a fire-sale.
I have no idea where the New-Geron (with JNJ as a partner) PPS will go, or if JNJ will decide to absorb the New-Geron as they absorbed Janssen. I do know that IMET brings remissions to blood cancer patients, we don't understand the reason why, but we believe it has to do with telomere lengths. The PPS and IMET's "success-score" in the upcoming global trials should be correlated, but they have not been in the past.
The FDA in the USA; Similar organizations in other countries; JNJ/Janssen's global trails:
1. The set-back of the FDA safety-liver-holds (now lifted) is behind us based upon Mayo Clinic's transfer of MF data (from Dr. Tefferi) to Geron.
2. (ODD) is a form of limited advanced approval, with each case based on its on merits, that allows the limited use of a unique, needed medicine (Imetelstat or IMET). This happened after that same data (from Dr. Tefferi) was transferred from Geron to JNJ/ Janssen (Geron's new and dominating partner), and was reviewed by the FDA.
3. JNJ/Janssen is now bringing order to IMET's new trials (36 sites), based upon discussions with the FDA and similar organizations in other countries. Under Dr. Tefferi's direction the new trials are designed to expand on Dr. Tefferi's original work at Mayo Clinic, to fill in the gaps of incomplete information (dosage, resistance, safety, etc), and to point to future uses for IMET, including new research projects.
Imetelstat summary 5 conclusion (from sdrawkcabeman)--"The focus has been on Imetelstat as a single agent. But that's not the future. "
I suggest, that anyone that is interested in Imetelstat as an investment and as the future of medicine, read sdraw**'s detailed (5 part) summary. Thank you sir for your detailed and informative explanation.
mainecoastlover1--You are a pest and an imbecile. I don't know if I should despise you or feel sorry for you. You are a disrupter, in the worst sense, and apparently enjoy that role. As an investor and a retired scientist (non-biological), I am trying to learn and appreciate the ideas and thoughts of others. I think that you are smart enough to make a positive contribution to this board.
JNJ/Janssen will push IMET to the maximum. We are just beginning to understand the science of and the role of telomeres:
1. MF (blood cancer--1st successes)
2. MDS, AML (other blood cancers)
3. cancer stem cells
4. solid cancers
5. aging cells
6. immortal cells
The fundamentals of life are locked away here. This will be a major focus of medical science for the rest of the 21st century and beyond. More immediately the 36+ JNJ/Janssen (24 week) trials will provide new information about the potential and safety of IMET. Geron found IMET, brought it to Mayo Clinic, and partnered with JNJ/Janssen. JNJ/Janssen is about to discover "hidden-details" about IMET (good, great, or miracle). We, as long term investors, will find out how that effects the PPS. The world is watching and waiting.
The FDA realizes that the work with IMET is just beginning (with the IMET successes at Mayo Clinic) and there is much work to be done with other cancers and combination medicines. Orphan drug status provides a financial incentive to develop this drug, but immediate use for needy MF patients is another.
You are correct about the "long and short" channel traders. These are not long term investors, who are a different breed entirely.