Two levels of comparison:
1. Non-curative for symptoms only: spleen size, etc.
2. Curative: remissions and possible cures
There is no correlation between Geron's PPS and IMET's acknowledged medical and scientific breakthrough qualities. Geron's PPS has to adjust to hedge funds, margin calls and bear raids. Information from JNJ's 65 sites will settle all arguments. The FDA has already granted ODD status for IMET, which is breakthrough approval for an orphan drug. Everyone knows that Mayo Clinic's original MF results are honest and of the highest quality, and that JNJ will confirm those results at their worldwide trial sites. In addition IMET will replace JAK as the BAT (Best Drug Available), as JNJ/Janssen plans.
This is why you are wrong. Geron PPS is being controlled by a very sophisticated computer program, but it cannot control real data. The recent ODD status from the FDA is now influencing the PPS. The JNJ new trial data, which is still many weeks away, will be the dominate controlling force long term.
Everything that you say is true. Still there is no correlation between Geron's PPS and IMET's acknowledged medical and scientific breakthrough qualities. Geron's PPS has to adjust to hedge funds, margin calls and bear raids. Information from JNJ's 65 sites will settle all arguments.
The PPS seems to be holding its head above water (over $3) in a tough-crashing-market that is influenced by world events and China. Of course this has nothing to do with IMET's medical qualities, but has something to do with margin calls, hedge funds and the recent "bear raid".
As long as IMET's Nobel Prize science and medical successes are in place, the depressed PPS will catch up. The JNJ trials are only 24 weeks long, and announcements of new remissions could come in several weeks. Remember this is partly a comparison between IMET and JAK for the BAT (Best Available Therapy) title. The MF patients, who are to be treated, are beyond hope, since they have tried JAK and eventually quit.
Black*****---Geron and Chippy are not factors anymore when IMET is the subject. All that matters is JNJ's new worldwide trials and the results. Chippy is now enjoying the good life, as a very rich man and little responsibility. That may be hard for you to digest.
Pinch yourself and you may wakeup from this dream (nightmare). This is not the real world.
It is JNJ/Janssen's management that is to blame. They have chosen silence until all the information is in their hands for detailed and definitive analysis. All bases are to be covered (good & bad). We have no idea when they will acquire new data, and when they will release the conclusions.
I never thought that the PPS would close under $3 again. I was obviously wrong. Does that put the effectiveness and safety of IMET into question? Is "ODD" for IMET some sort of practical joke? I believe the answer to both questions is No.
I only know what I read, and have made the assumptions that Mayo Clinic and JNJ are honest and know what they are doing. Everything that I said is public knowledge. Geron, as JNJ's junior partner, is under their control.
There is no way of knowing exactly when these events will happen, but we are talking weeks. With 65+ trial sites this will be a continuing process. We do know that the process is underway, and the hoped for successes are coming as confirmations of Mayo Clinic's earlier results.
1. Patients' selection
2. Patients' infusion
3. Patients' remissions
4. Patients' progress reports
As far as I can tell IMET has met all challenges (safe, effective, needed, remissions, unique). Geron's PPS (market forces and manipulation) and IMET's successes are not correlating in the short run, but longer term they should. JNJ's new trials will reveal all, and will give the FDA and similar agencies (worldwide) the volume of data that they need for complete approval.
There is always the concern with any medicine on trial, that at the critical moment some major negative effect will be revealed. I don't see that happening with IMET, since it has been vetted in so many different ways over several years.
As far as I can tell IMET has met all challenges (safe, effective, needed, remissions, unique). Geron's PPS (market forces and manipulation) and IMET's successes are not correlating in the short run, but longer term they should. JNJ's new trials will reveal all.
No surprise here, as the PPS begins to recover. There is no negative news about IMET, so the bounce back had to happen, IMO. As long as IMET "performs", the PPS will eventually respond higher. We have all learned how completely the PPS can be manipulated. This has nothing to do will IMET's quality, effectiveness or safety. I have no idea how a "Bear Raid" is organized, but it has conspiracy and illegal overtones.
drugs***** states, "--(not) safe and effective and legal to manufacture and market in the United States". IMET is all of these things in the affirmative.
ODD allows the drug (IMET) to be manufactured, marketed and distributed in the USA for MF, as the safest and most effective drug available to-date . This is not a full approval, but a partial approval as the FDA waits for additional data. JNJ/Janssen is going to "extremes" to confirm Mayo's earlier successes.
Trying to Define an Orphan Drug (ODD)
There is no satisfactory definition of an orphan disease. In the USA it is defined as one that affects fewer than 200 000 individuals, but in Japan the number is 50 000 and in Australia 2000.
An orphan drug can be defined as one that is used to treat an orphan disease. For example, haem arginate, used to treat acute intermittent porphyria , is an orphan drug. However, it comes as a surprise that ibuprofen can also be categorized as an orphan drug, because it has been used to treat an orphan disease, namely patent ductus arteriosus in neonates (whether orphans or not). This observation stresses that barriers to the development of orphan drugs do not occur only at the premarketing stage; in some cases it may not be commercially worth mounting an efficacy trial, even of a drug whose efficacy elsewhere is well established. Indeed, there may be little incentive to mount an efficacy trial of a well established drug in a rare condition, or even in a relatively common condition in a subgroup of individuals – consider the many drugs that are licensed for use in adults but not in children.
In the last 20 years efforts have been made to encourage companies to develop orphan drugs. The Orphan Drug Act in the USA (1983) was succeeded by similar legislation in Japan (1985), Australia (1997), and the European Community (2000) . The encouragement takes three forms: tax credits and research aids, simplification of marketing authorization procedures, and extended market exclusivity In Europe only the last is available.
Correct me if I am wrong.
If I am correct (which sometimes happens) the Geron PPS should start back up on Monday and be back to $4 in a short time (a week to 10 days). IMET's management is now controlled by JNJ, and the FDA has shown positive inclinations (ODD) toward IMET. Some of the 65 or so trial sites will start infusion very soon, and confirming data will follow (%'s of remissions, improvements and stabilizations). Remember that JNJ is treating the sickest of MF patients in these new trials with IMET, that have tried JAK and given-up hope.