It is a waiting game. JNJ is willing to wait, and so am I. With their very deep pockets time is not a factor. They are striving for completeness and fairness. IMO, they already know the results, and they are confirming Mayo's successes.
Why is the FDA so slow in granting full approval? What concerns could they still have about the safety and effectiveness of IMET? IMET is not perfect, but what cancer medicine is? IMET seems to work well in certain combinations.
As I understand it, there are other ways to cure ET that are both less expensive, but also far less pleasant. IMET seems to be the way to go, if you can afford the treatment. I don't believe that option is currently available, but should be considered in the quest for full approval.
I have been saying this for a very long time. Both the FDA and JNJ know all of this. Market forces and manipulators are now controlling the PPS, but the medical successes will prevail, soon I think.
Do the JNJ officers (Caruso, Mesquita) and Scarlett even know each other? It would great if their presentations complement each other, with praise and the potential of IMET, but that probably won't happen.
Wow--what lies. No wonder the USA is in trouble, with fascist mentalities such as yours around.
As far as I can tell, there are 2 options: death and IMET. The FDA and JNJ must know this. Is there a 3rd option?
From darns--"If what you just wrote (for the 100th time) is true, they wouldn't need to run more trials. But they do and they are. I'm hoping these comprehensive trials mimic the smaller ones, but it's yet to be seen"
I wrote this so many times because it is obviously true. JNJ wants "absolute certainty" that will eliminate all controversial questions about IMET, and make the drug available on a worldwide basis for any and all applications (cancers, combinations, aging, research, etc.). The FDA and JNJ work together for the best results. The NEJM articles and ASH have already come to the right conclusions. JNJ is not financially depend on any one product, so time and completeness are on their side.
What does "Tantamount to a Cure" mean for Imetelstat? Mayo Clinic stated this, and JNJ fully supports this, by telling all that IMET is "transformative". IMET is safe, effective, and brings remissions and cures. There is no reason to believe otherwise. The time for "bad news" about IMET seems long past, with only "good news" coming.
What can they possibility say that hasn't been said before? Could there be new data and analysis from the Janssen (JNJ) worldwide trials (IMET for MF & MDS)?
Geron=JNJ Jr. As IMET goes, so goes Geron.
What are the chances that JNJ cannot repeat Mayo Clinic's IMET results, with more depth and sophistication? Almost zero, at this point in time. Still, there is that lingering doubt, that has crushed the PPS.
It is worse than that. The worldwide/JNJ trials must confirm the Mayo Clinic (IMET) successes. Some must believe that is not going to happen (Geron PPS). I keep looking for bad-IMET-news, but cannot find any. My hope is that JNJ already knows the results, which are very positive, and is waiting for a fuller set of data and analysis before publishing.
This seems to be the case. The FDA knows all of this, and JNJ must be reinforcing the message. No one seems to be in any rush to grant advanced approvals beyond ODD (US & EU). IMET appears to be "nearly" a sure thing, with JNJ being in no hurry until more of the worldwide trial data is gathered, analyzed and published. JNJ does not need the money or the product immediately, but the markets are confused and "in panic mode".
That is all that matters now for Geron's PPS. JNJ, by this time, must know how the trials are going. When will they tell us (interim report)?
There are not enough believers. JNJ has to say this (or the equivalent) confirming Mayo Clinic's successes with data from their new trials. "Unprecedented- cancer cures" needs overwhelming evidence, apparently.
JNJ and IMET (Geron's PPS) both look to be a "safe investment" in a world where stock markets are coming under increasing pressure. Geron gets caught in the general market of small biotech companies, but they are protected in the long run by JNJ's strong position (financial, medical, legal).
Five major subjects for 2016:
1. US energy independence and oil's place in the world
2. China as a friend, enemy, competitor and an ally
3. The middle eastern wars and ISIS
4. Russia's financial collapse
5. USA election