There is only very positive news from Mayo Clinic, JNJ and the FDA. No one else counts. As soon as the FDA gets a full complement of data from JNJ for IMET. the approval will be advanced from ODD to Breakthrough.
At some point logic will take control but we are not quit there yet. The combination of the FDA's endorsement plus the volumes of data that JNJ will generate from 65 trial sites worldwide will overwhelm all other considerations. JNJ/Janssen is taking the "high road" by anticipating and answering all possible questions about IMET. They know that they have a winner, and they are generating "proof-positive" for the doubters.
There is no logical reason to choose JAK over IMET (remissions) as a 1st line treatment. Now that IMET has ODD status IMET should be available to all MF patients. I don't know what status JAK has, or if at times the two medicines can complement each other.
This makes sense, since the FDA would only grant "ODD status", if they knew that the drug was safe, effective and, most important, that they wanted MF patients to have the opportunity to use it. This is an acknowledgement that IMET is, "the best game in town", but they (the FDA) still does not have the whole picture, which is currently being supplied by JNJ (new trials worldwide).
I don't think Dr. S is a major factor anymore, which happened the day that Janssen became the senior partner. I am sure that he will stay for the ultimate payoff, and as long as he can. Mayo Clinic's successes and the FDA's ODD are enough to convince me, but most others appear to be waiting for reports from Janssen from the new trials and confirmation of Mayo's MF data.
The only thing that I am worried about is Janssen not being able to duplicate Mayo's results. This seems like a small worry, since Janssen has the advantage of having reviewed all previous data, plus having Dr.Tefferi on their staff. These "market-games" will vanish once the new trials start and results are announced. Of course this could go either way, but the deck seems to be stacked in IMET's favor.
So far there is no evidence, that I can find, that takes a company that is undervalued at $4+ down to $3+, that has anything to do with new news. The planning to attack Geron so effectively must be both brilliant and sinister at the same time. Since I have no idea how it was done or who is controlling these moves in the PPS, it is impossible to know about the legalities. If it is "only" a bear raid, the stock should recover very soon.
As far as I can tell, there is not even a rumor of any kind of medical problems. ODD status would not have granted if there were any serious concerns. It looks like the burden of proof (Tantamount to a Cure) has shifted to Janssen, and they seem to be up to the task with about 65 trial sites. Geron does not have any financial or criminal problems that could impact the stock.
Small samples have some statistical problems (error bars, patient selection, etc.) but I don't see how remissions can happen by chance. I agree that, "The Mayo Clinic is pretty unimpeachable as a data source". It seems to me that Janssen (JNJ) will also see remissions, for sure. If they do not, there are many question that need to be asked. As you point out, let's do the studies and then we can make comparisons. This is a time to wait and see, and there is no other alternative. Going into these new trials, all of the available data looks positive, but IMET does not work for everyone. Most benefit with improvements and stabilization, with some remissions and possible cures (too early to know).
I agree. Someone from the partnership could assure us that everything is on-track, and all IMET news is positive. JNJ/Janssen may be waiting for overwhelming results from the new trials to settle all arguments.
As far as I am concerned, Mayo Clinic's good results and the FDA's ODD status tells us everything. But the PPS isn't following the good news. Apparently most interested investors are waiting for further confirmation from JNJ, that IMET works and is safe. That confirmation may take some time, but we should know before the end of the 24 week trials. Will JNJ publish interim results?
Statistically, it is next to impossible not to have remissions and improvements, unless the Mayo Clinic data was faked (why would they do that?). The %'s will vary. These trials are going directly after the sickest of the MF patients, that have tried JAK (Incyte) and have given up. Remissions in this group would be outstanding.
What are the chances that the Mayo Clinic data (remissions and improvements) will not be confirmed by JNJ, with ODD approval already under our belt? I would say none, at this point in time.
The very good news and the JNJ trials should send the PPS soaring, but market realities seem to want to push it back into the high $3's. My bet is on the good news and JNJ, but it is taking awhile.
Gilead appears to me to be way undervalued.
"At current prices, GILD sports a P/E of 13, a forward P/E of 10, and a PEG of 0.47".
To an MF patient (or any blood cancer patient) it is easy to give up hope. IMET not only brings hope, but it brings at least some improvements and/or stabilization to about 80% (MF, Mayo Clinic). Remissions of any kind are miraculous, and cures would be beyond miraculous. JNJ/Janssen is going international with IMET, and is seeking universal approval. There is no reason to stop or slow down this process. We still have to confirm Mayo's successes with these new international trials. ODD should get IMET to many who need it now, while the details of the confirmation are formally put in place for a higher level of approval.
That has been the case. Imetelstat was a huge gamble, as Geron traded in their used-car (hESC) for a new one (telomeres). There is a connection between human embryonic stem cells and cancer stem cells, and Geron is in a position to benefit from breakthroughs in both. We are in a new world, the world of JNJ/Janssen, where there is enough expertise and financial strength to pursue stem cells in all of their forms.
mruyog--Three may be many reasons that the stock has been held down; "market resistance": hedge funds that play small biotech companies, Geron's residual reputation from hESC's, dislike of Geron's management, belief that IMET is being hyped, FDA favoritism to others (Incyte for example). Many institutional investors cannot buy stocks that are listed for less than $5.
My belief is, that under JNJ/Janssen's control, IMET will overcome all of the obstacles of the past, and the PPS will soon reach $5, as IMET is endorsed internationally.
"The Die is (still) Cast"---All news about IMET is still good. The PPS tug-of-war continues. In 24 weeks (the trial time) or less, we will know much more about IMET.