The FDA is critical to the future of Geron's PPS. The FDA has every reason to grant (immediately) some advanced approvable for IMET. That means they will, unless there is something hiding in the closet, that we don't know about. (I don't think so.)
Questions are: (1) What is the FDA thinking about IMET and "Fast Track"? (2) Has IMET met all of the criteria for "Fast Track" ? (3) What reasons could the FDA have for not guaranteeing "Fast Track" ? (4) Is JNJ talking to the FDA about "Fast Track"? All of these discussions are confidential, so "Fast Track" could be "Imminent". When it happens it will be a surprise to everyone..
Additional questions are: (1) What is the FDA thinking about IMET and "Fast Track"? (2) Has IMET met all of the criteria for "Fast Track" ? (3) What reasons could the FDA have for not guaranteeing "Fast Track" ? (4) Is JNJ talking to the FDA about "Fast Track"? All of these discussions are confidential, so "Fast Track" could be "Imminent". I hope so.
My belief is that "Fast Track" or "Breakthrough" should have happened yesterday. Imetelstat (IMET) is effective, safe, unique, and needed now for life threatening diseases (Blood Cancers including MF, AML & MDS) which are cancer-cousins. IMET is a proven drug in humans (MF trials at Mayo Clinic). The FDA is aware of all of this. Logic says that it is "Imminent", because IMET has met all of the criteria.
"IMET is something special and J & J knows it"--(from Adrian******)
That is why we hold Geron. There is always that feeling that there is something we don't know that will "kill-us" as long term investors. At his late date, and with JNJ as a partner everything is looking promising. Mayo and JNJ are partners above reproach, and know what they are doing. The stock price, under $3.00, is disturbing, but FDA approval will reverse all hedge funds.
I think they can do both. Of course FDA approval is at the top of the list. But the public should know more about IMET and its cures and remissions. This is the age of information.
BigK & BlackM----I believe that if Dr. T and Dr.S both saturate the health conferences with the updated truth about IMET, the PPS will follow. Janssen Biotech needs to get someone on the road to make this a 3-ring-cicus, and get maximum investor, research and global exposure.
The QUESTION round at the end of the presentation was unique. I thought the talk was excellent, but there were NO questions, to Dr. Scarlett's surprise. He said that either he did an outstanding job, or the talk went over everyone's head. Considering the group, I suspect the latter dominated. With Dr. T and Dr. S (great spokesmen) presenting at so many health conferences (ASH & beyond), with such outstanding data and promise, IMET will catch-on with the investing public (A CURE FOR CANCER, with great potential in combination). JNJ and the FDA are yet to be heard from. For now we are talking about blood cancers (MF, AML, MDS) that are kissing cousins.
"The liver toxicity issue is one that I was convinced was a non-issue last summer 0f 2014, and so, get the word out to the media and potential investors that this is history and so are other safety concerns for the FDA approval of imetelstat."--(jackdaw605)
It has always seemed to me that the safety issue was the only issue that had prevented FDA breakthrough approval. That no longer appears to be an issue, so approval should be forthcoming. "Tantamount to a Cure", by Mayo Clinic, is still the rule.
NO NEW SAFETY PROBLEMS HAVE BEEN OBSERVED. Imetelstat is a winner with benefits for the team (Geron-JNJ-Mayo). The only negatives are potential safety problems, and they do not exist. It seems to me that all the criteria for FDA breakthrough have been met, and GERN PPS will respond. ONE DAY, BUT WHEN (soon, I think).
FDA breakthrough approval is very close.
What is a "REAL INVESTOR"? Investing is part economics, part doing your homework, part luck, and part knowing avoiding the corrupt. We will never know "the path forward" in any detail.
This is a play for the rest of the century for IMET (telomeres and telomerase). Geron will be absorbed by Janssen Biotech (JNJ), as FDA approval becomes more likely everyday. The price may already be fixed. You will be surprised at the speed (NEW GERON=JNJ Jr.).
My average price is $2.80, and the downside-channel-boundary appears to be $2.90. This is too good to be true, but there is that belief that; "What you don't know will kill you". I expect IMET (Geron PPS) to explode to the upside, as this APPEARS to be a sure thing. I am afraid to buy anymore.
As far as I can tell, Mayo has PROVED that IMET works very well in humans (MF, safety), with potential in all cancers, cancer stem cells, and immortal cells. IMET is unique and is needed now. The FDA certainly knows this, so breakthrough approval should and could happen tomorrow.
FDA approval should have happened yesterday, but may happen tomorrow, with JNJ now in charge. This stock is being played for a maximum "bang" on the upside, as all shorts scramble at once to cover.
You don't understand. IMET is already a success, but the Geron PPS is controlled. These are 2 very different items. The PPS will catch-up.
I don't know. It looks like some are waiting for FDA approval. Considering the uniqueness, effectiveness, safety and potential of Imetelstat (IMET) approval should have happened yesterday, and it may happen tomorrow. No frauds or hoaxes are in the picture.
Approval of some sort should have happened yesterday. All health conferences, including todays, are positive.