You left out the timing of the Market Realist lie relative to the publication of the Im studies in NEJM. THAT's the one that has me reaching for the tinfoil.
I love how Geron maniacs' money [indirectly] swells my brokerage accounts.
Did you try that one guy's "best pairs trade in the market?" BUST-O!! Did you sell when that other guy said it was high time to short Incyte? Woulda been a bad idea then; HE claimed he waited 2 1/2 months and then did it--bad idea 2 1/2 months later, too.
I'm pretty concentrated these days. Always been a "...and watch the basket" investor.
Half the float of Myriad (maker of genetic cancer risk tests, loser of human gene patent suit) is sold short (evidently advised by Goldman). The company clearly isn't failing, so they have to cover some time. But the catalyst that I thought might turn that from pressure into a corner didn't come together. Still worth taking a look.
FDA said that they understood Geron would not go after MPNs less serious than MF in the statement that lifted the hold on trials. Anyone who has ever dealt with FDA sees that as a condition of the release. If Im does well for a few years, FDA might then allow trials against PV.
As for that Nobel-Prize-Winning science, you are clearly out of the loop. The pretty picture of telomerase inhibition permitting fraying of genes off the ends of chromosomes no longer appears to be the main way that Imetelstat acts. There are now three other suspected modes of action that I know of. I've said before that I prefer the results to the explanation, but without a straightforward explanation, it is hard to extend predictions beyond the existing results.
This is mostly an attempt to get beavertail splash to leave the article about the Motley Fool. That one is getting long.
Basically, almost anything can happen once, and can seem significant if there are few enough other cases looked at simultaneously. One of my favorites to cite is Doyle Brunson's melanoma. I'll steal a bit from the Wikipedia article on him:
Brunson met his future wife, Louise, in 1960 and married her in August 1962. Louise became pregnant, but later that year, a tumor was discovered in Doyle's neck. When it was operated on, the surgeons found that the cancer had spread. They felt that an operation would prolong his life long enough for him to see the birth of the baby, so they went ahead with it. After the operation, no trace of the cancer could be found.[Fuller version in Super System 2]
Brunson has attributed his cure to the prayers of friends of his wife and their correspondence with Kathryn Kuhlman, a self-proclaimed Christian faith healer. Louise developed a tumor shortly afterwards and, when she went for surgery, her tumor was also found to have disappeared.
Best evidence from the Mayo demonstration (and not very robust at that) is that infusions of Im can be reduced to 2 every 3 months in favorable cases and still maintain disease control. There aren't the long follow-ups available for Jakafi. Let's see some results from Janssen.
This was new to me. There's a video on youtube debating whether JAK-2 inhibition prolongs life of MF patients. Interestingly, the guy arguing 'Yes' said yes, and the guy arguing 'No' said not always. But to the point: at least one mechanism of resistance to JAK-2 inhibition has been identified; formation of heterodimers that replace the signaling function of homodimers. To the extent that the "other" kinase can be identified, it can be inhibited too. One presumes that work is going on...
You can beg and differ all you like, but there is no evidence for this statement. The strongest statement that isn't completely unsupported is that patients treated with Imetelstat who achieve complete response seem to be able to tolerate a longer interval between doses. And even that is a stretch--sample sizes too small, times too short and no control group.
It is difficult and probably unethical to do a study with a survival primary endpoint on a treatment for a condition with great morbidity and median survival longer than 2 years. Basically, you have to maintain an undertreated control group beyond the time when the benefit of the treatment is evident if you need statistical significance for survival. Would YOU consent to be a subject in such a study?
Adaptive study designs are generally used in higher-risk trials. So from that I'll guess that the developer considers this a long shot. From the many instances in which an attack on the abnormal sells in MF allows fibrosis to heal, the mechanism of action looks inappropriate for this condition (fibrosis at those other sites doesn't heal so easily).
I got seriously whipsawed in ITMN back then, but it was clear that they had enough money for the required study, and while they didn't have a formal SPA, the ground rules were clearly that they only needed to show as much as they'd shown once before to get approval. It's nice when you have that much detail to work with. That third study was where I learned about goosing BOTH experimental and control group with likely responders (as Incyte has tried to do in Janus-1).
Hey, this is easy. No new typing. (but I have to split the reply)
I am "jacosa," known to Geron enthusiasts.
This article seriously mischaracterizes Incyte and Jakafi.
The FDA-approved 'label' (professional package insert) for Jakafi includes, on page 8, Kaplan-Meier graphs from follow-up studies of the original registration studies of Jakafi. Looking at the horizontal separation of the curves at 70% survival, a substantial survival advantage is evident for Jakafi.
Casual dropping of PRs and CRs into discussion is characteristic of Imetelstat enthusiasts. What those MEAN is complete relief of symptoms combined with partial of complete normalization of bone marrow appearance on biopsy. I claim that UNLESS THERE'S A PROSPECT OF CURE the biopsy improvements are of absolutely no interest to patients. By cure, I mean complete relief of symptoms lasting "long" after treatment is discontinued. This is not claimed for Imetelstat. Jakafi produces complete relief of symptoms at least as often. There are also published examples of PRs in Jakafi treatment of MF.
Partly, I'm sure. But also partly because of the 2 investor presentations next week. Mostly, you've had to read tea leaves to realize that something important has happened in the Merck collaboration. Even by saying explicitly what we already know (that the p2 is now therapeutic phase), there's potential for a big further move. If more of those little combo trials are doing the same, well...
The spread between what Board members think the company should be worth and what can be justified to an analyst is still too big for a take-out to be likely, but you CAN see that territory from here.
Don't get me started. Harkonen ought to have realized how vulnerable his position was, but the drastic over-response could fill a book. Still and all, he was probably replaced mostly because the board wanted a lower-key public face.
Ok, I replied. As usual, I had little to say about Geron, but the story on Incyte was clearly repeated from a hostile source.
I should mention: in his position as medical director of the Janssen study, Tefferi would look very out of place making a cheerleading video like this, and might arguably be at risk of an SEC smackdown if he did. So this can be seen as Yet Another Tefferi video, with a stand-in presenter.
1) She was on the Tefferi demo group paper (casting doubt on her credibility)
2) She distorts the truth in saying that IM is the only telomerase-targeter in trials (IFN is, too)
3) She only talks about IM's anti-telomerase action, while the clinical story is much more complicated
4) The Janssen phase 2 is obviously suffering teething pains (HOW many patients infused?) Even if everything goes perfectly from now on, it will be 2 years before IM could imaginably be marketed. By then, Jakafi for MF will be no more than 1/3 of Incyte's sales.
I have resisted urges to scribble up the Geron discussion; you should resist urges to scribble up this one.
I can't recall a dose-determination being reported separately at a meeting. For a therapeutic phase 2 vs relapsed melanoma, I can't see having enough data to talk about before EoY, so I'd guess soonest possible look at results would be early Spring. Which isn't to say that Merck (who are perpetually short in the pipeline) might not start bragging qualitatively before then.
Goes along with MYGN's recent strength. A lot of people re-evaluate at such milestones.
No clear catalyst to produce a corner, but just because of seasonal patterns I wouldn't want to be short Myriad in January.
Upsizing is kinda implicit in the trial designs, as originally announced. It marks the shift from the dose-finding phase to the therapeutic phase, and is a parallel to the futility evaluation date in a phase 3 trial. From that standpoint it is indeed an optimistic sign. Earlier statements have suggested that Merck, at least, hopes that results from the therapeutic phase 2 trial may be sufficient to convince FDA to allow marketing of an epacasostat combination before [presumably WHILE] a phase 3 registration study is done.