They have already created "positive momentum": JNJ, Stifel, Piper-Jaffray, ASH. The "BIG BANG" will soon happen, initiated by an FDA "fuse" (perhaps fast-track"). Geron is despised by some, but JNJ is now in charge.
As far as the medical and scientific worlds are concerned, IMET has been successful (MF) in humans, and shows exceptional potential for AML (from animal tests). The Washington Post (Sep. 2014) summed up the problems that short-hedge-funds can cause small biotech companies, but IMET is now protected by JNJ. Geron does not quite seem to be "out-of-the-woods", but they are almost there. Fast-tracking from the FDA seems appropriate, based on recent safety profiles and successes of IMET. Whatever is holding the PPS back, it has nothing to do with medical-scientific evidence, or the quality and deep pockets of it partners.
Patience is difficult, but with JNJ (Janssen Biotech) now a critical part of the team, Geron's PPS success is very, very likely. There is always that small possibility that something may go wrong, so I am not betting the house. At this point in time, I do not expect any important negatives.
I don't know the date, but there is absolutely every reason for IMET to be fast-tracked. The drug has been proven safe, life saving (100 weeks & still going), effective, unique, and is needed by MF patients immediately. All of the FDA requirements have been met. In addition, the FDA has a giant at their doorstep (JNJ/Janssen Biotech) to reinforce Dr. Tefferi's efforts (Mayo Clinic is the USA's #1 research hospital).
IMET should be fast-tracked, while the calendar still reads 2014, and the FDA is capable of surprises. Few on this board expected the liver-holds to be gone so early on. Fast-track is coming.
IMET is a critical part in the quest for the cure for cancer, at the cancer stemcell level. That is the message from ASH.
It means that the disease stabilized, I believe. It is less of a result than CR, PR, or CI, but shows that the drug was useful and safe. I believe the number 80% was quoted.
JNJ's revenge is coming, when they buy all outstanding shares. The short-hedge-funds have been amazing, but their day of reckoning is near. IMET does not cure all cancers, but is a key building block (in combination or alone), in the war to get cancer stemcells.
The market manipulators are very good at what they do. Still, a drug that is so effective and safe, with no new negatives, will not be held back much longer by the FDA. Why would they want to do that, and what motives could they possibly have?
Short-hedge-funds, and their effect on small biotech companies, were completely described by the Washington Post, and have been reviewed in detail on this board. I am sorry that you do not recognize or are convinced about the existence of JNJ and Mayo Clinic as very powerful partners of Geron, but that is "believable". Geron has a "remarkable medicine", and super partners.
I will be very happy if it gets to $5 by Dec. 31, so all of the institutional investors can take a crack at it.
There is no bad news, only good news. We have had 3 important conferences in the last month (Stifle, Piper-Jaffary, ASH) and they have all been very positive. These MF studies are very honest and fair trials, with very good results. I can't see anyplace for Geron PPS to go, but up. Of course, I don't understand the market forces that still seem to be in control, so I am only going to invest in the fundamentals: medicine, science, partners (all 3 look very sound). The FDA voted "safe & effective", which was a huge hurdle to jump. This company always surprises. I believe both Drs. Scarlett and Tefferi know exactly what they are doing, and why they are doing it. IMO, the shorts are toast.
The stock trend-line is upward to $5 by the end of the year, and then accelerating when it is open to all institutional investors at $5. This will be a very strange, zigzag path upward, as the short-hedge-funds do their best to hold the PPS in very defined channels. IMET is "too good" for them to succeed.
NEW GERON=JNJ & Janssen Biotech + Mayo Clinic
The continuing good news from Mayo Clinics MF studies (humans), and the complete effectiveness in Australia (mice) in AML, especially treating relapse after chemotherapy, with combination drugs (also Amgen-Yale studies) show that even better results are likely to follow in 2015. I think the investing community is slowly getting the message. Geron had much to prove, and partners to find. They did it all.
Mini-summary from Slide #12
1. Data continues to suggest that imetelstat has disease-modifying activity in MF
2. Continue to observe unprecedented and durable remissions (CR+PR)
3. Recent exome analyses have strengthened the evidence that imetelstat’s principal
mechanism of action in MF is inhibition of the malignant progenitor cell clone
4. No new safety signals have been observed
5. Myelosuppression continues to be the principal dose-limiting toxicity
There is no doubt left. IMET is a "remarkable" medicine, and even better in combinations apparently. That will be emphasized in 2015 in AML, MDS and MF, plus perhaps some trials that involve solid tumors. No new safety issues have come to the surface, so progress will be unimpeded. A safe drug, obviously, will be sought after by patients and researchers. JNJ has been very wise in making this selection.
As the team's successes in MF, MDS and AML become globally recognized, the PPS will trend upward. At $5 dollars many institutional investors will have access to the stock. At that point, the stock will likely move upward, faster. The short-hedge-funds are market savvy, and not to be underestimated, but I believe they have lost control.
There is a close relationship between MDS and AML . MF (human studies), MDS and AML were reviewed at
ASH 2014. Maintenance, relapse control, and prevention are all roles for IMET (alone or in combination). JNJ chose well.
"Myelodysplastic syndromes, also known as MDS, are a group of blood and bone marrow disorders. In MDS, stem cells do not mature normally, and the number immature cells, called blasts, and abnormally developed cells, called dysplastic cells, increases. Also, the number of healthy mature cells decrease, which causes the bone marrow to not work well or to stop working. This means that there are fewer normal red blood cells, white blood cells, and platelets. The numbers of blood cells are often called blood cell counts.
Because of the decrease in healthy cells, people with MDS often have anemia, a low red blood cell count, and may have neutropenia, a low white blood cell count, and thrombocytopenia, a low platelet count. Also, the chromosomes, or long strands of genes, in the bone marrow cells may be abnormal. Sometimes, the numbers of blood cells can be normal, but the blood and bone marrow cells are still abnormal.
There are several subtypes of MDS, and some subtypes of MDS may eventually turn into acute myeloid leukemia a cancer of the blood in which immature cells called blasts increase and grow uncontrollably."