At $10 a share everyone will believe, and long term investors will be elated. At $15 a share, I will retire.
My premise is that JNJ/Janssen is calling the shots, and Dr. Scarlett is part of the team (super employee of sorts). JNJ has "faster tracking special designation" for numerous drugs (some recently).
One day those that are continuing to short Geron will be caught off guard. The FDA and JNJ talk to each other, and know how good IMET is. JNJ is not sleeping.
No one knows what discussions have taken place between the FDA and Janssen (JNJ), but IMET looks solid, with no significant negatives, and many unique positives including life saving properties. JNJ is not sleeping.
JNJ is not a rookie in dealing with the FDA. Geron was not able to overcome the obstacles of going-it-alone, and wisely chose an experienced oncology partner (JNJ) that knows-the-ropes, and can protect them from market-vultures. JNJ will not let IMET languish. Geron appears to be in a good place.
Merrill seems to be a new voice supporting Geron's PPS. The brokerage firms that move the PPS are now believing the IMET story. Piper Jaffray and Merrill are two of the best known, and with them on board, the short hedge funds will have difficulty holding the PPS down.
The evidence of an outstanding medicine seems to be uncontested. The PPS will creep to $5, or explode when FDA approval arrives.
JNJ/Janssen Biotech has a history of seeking and getting "advanced approval". They are in a very strong position with cancer remissions, combination therapies and Nobel Prize science as part of the IMET story. Obviously, the FDA and JNJ talk to each other about patient's benefits, and IMET approval. The "silence" is being maintained such as the lack of noise from these two is overwhelming and planned. In addition, IMET has the "blood cancer basket" in its favor.
To Jack: What you say is somewhat true, but mostly wrong. The FDA does talk to other regulating agencies, but I doubt that groups in other countries are influenced very much, especially when JNJ is encouraging use with overwhelming positive evidence. Certainly the FDA has no authority outside of the USA, and in some cases, may be considered unwelcome. Inside the USA, for better or worse, the FDA rules for now (some states are changing some rules), but, so far, they have been very slow to act in the case of IMET, a life saving medicine. IMET could be approved outside of the USA, while the FDA sleeps, and patients are not well served.
(from Irish) "As for combined basket study, it seems almost tailor-made for ET PV MF MDS and AML conjoint studies because myeloid cancers share genetic footprints."
This list alone, considering the positive safety profile, should be enough for approval in the USA, and in other parts of the world.
Jack--This is an excellent post. "This is one of the reasons that I keep stressing the importance of combo drugs." This should get much attention. "There is a way around telomerase, in which cells can code for telomere maintenance without the enzyme." I think you are saying that all cancer cells contain telomeres, but Imetelstat (telomerase) is not the only way to control their length. Telomere length seems to be closely related to the survival of cancer cells.
The "market games" are still going on to my surprise. The Janssen/JNJ inputs and partnership makes this a $10 stock in the near future, as I see it. I am willing to wait, since I believe in the science here.
I have a gut feeling that the FDA has made up their mind, and the result is positive for patients and Imetelstat. When will they speak?
Certain: (Synonyms) assured, clear, cocksure, confident, doubtless, implicit, positive, sanguine
The exact meaning of "certain" is not "certain", and depends on usage. Nothing is a sure thing, but a very high degree of "confidence", based upon medical evidence, can be "Tantamount to a Cure" . Your use of the word "lying" is a sign of a very narrow understanding of the English language.
The data from Imetelstat (IMET) blood cancer studies (MF/MDS/AML) all appears to show that IMET is safe and brings remissions in humans. That alone should get the FDA's attention and advanced-approval. JNJ/Janssen and Dr. Tefferi are moving IMET forward as rapidly as they can. In my opinion, that makes for a very sound investment, with significant potential.
I think that JNJ spotted IMET early-on, when Dr. T first got involved with the MF trials. The talk of remissions only increased their interest. Geron was allowed to survive as a public company (matter for discussion), but JNJ now has control of IMET's future, which could take several paths. There will be no bidding wars, because JNJ has complete control, and has decided that corporate secrecy serves their best interests.
Dr. Tefferi moves to Janssen (Conference Call, March 3)
Janssen responsible for operational implementation of these activities.
Development of imetelstat will proceed under a mutually agreed clinical development plan, which is expected to include Phase 2 studies in MF and myelodysplastic syndromes ("MDS") as initial studies, additional registration studies in MF and MDS, and exploratory Phase 2 and potential follow-on Phase 3 studies in acute myelogenous leukemia ("AML"). The company expects the Initial Phase 2 MF Study to be initiated in mid-2015 followed later by the Initial Phase 2 MDS Study to be initiated at the end of 2015. Development costs for these two studies will be shared between Janssen and Geron on a 50/50 basis.
Prior to initiation of the Initial Phase 2 MF Study, both investigational new drug applications for imetelstat and the sponsorship of the MF Pilot Study being conducted by Dr. Tefferi will be transferred from Geron to Janssen. The primary transition activities related to the imetelstat program are expected to be completed by mid-2015.
If one only looks at the charts and the technicals for Geron, one gets the message "hoax". The medical successes give a completely different message (IMET, remarkable drug).
There is some valuable information on this board, but, of course, it all needs to be verified. All information indicates to me that IMET is real, safe, and remarkable (no hoax). The PPS has to follow the good-news that is already known.