Biglefthook_00, I mean. It posts nonsense, with a first sentence that seems to mean something, but trailing off into gibberish. It doesn't respond (and I've commented pretty sharply on some of its posts). Is it perhaps a travesty generator that some person starts with an investment-sounding phrase and then lets run until it devolves into complete gibberish?
Every headline and just about every analyst focuses on the part that ISN'T news. We already knew that Pirfenidone worked in the p3, and that the pooled analysis supports a presumption of a survival benefit. Nobody's headline says "BI drug causes nausea as well as diarrhea," which is the message of enduring commercial meaning from last night.
The conversational byplay about combining the two drugs struck me as important. While modes of action remain unclear, they appear to attack the same pathological mechanism at different stages. The unpublished result that the combination is tolerated by patients (not, in advance, a sure thing) clears the way for further investigation.
The cardiac death signal in the BI trials needs further examination. The numbers are small enough so it shouldn't prevent approval, but if it hasn't been removed/explained by then it will require ongoing surveillance.
The failure of NAC is unsurprising, but it had to be demonstrated to clear the field for effective drugs.
Advisory agreement terminated?!?! Never mind the end of the threatening and the legally problematic advisory fee. This means that the company can shop around for investment banking advice.
My big concern is that there may be another shoe, and we may not like it as much.
Angelina Jolie was a very special case. She has mutations that give an 85% risk of aggressive breast cancer if left alone, and plenty of family examples. With those odds, it almost wasn't preventive.
Most of the variants detected are far less threatening than that, and it becomes a very discussable question.
When trying to start a panic, it helps if you do it while markets are open. When alleging a catastrophic drug side effect, it's better if the drug in question has fewer than 10,000 patient years of open label history. Just in case you don't take my first suggestion and swallow lye.
A bit of a waving flag. That's a little over 1/3 of the convertible issue. Whether the company intends to merge or stay independent, clearing out the old debt is a useful step. So one way or another, we can expect to see more action. In the nature of things, you don't issue new debt after announcing a big R&D commitment, so this strengthens the case for a clear merge/continue decision by February. A new debt issue by then would telegraph an intention to stay independent. More negotiated redemption without new borrowing would suggest intention to merge.
Ok, it's a bet. MYGN goes to $50 for at least 2 hours any time within a month after the CMS decision, I'll post that I was wrong. Doesn't pass $45 within the month, you post that you were wrong. Middle ground is close enough to a tie for gummint work. On?
We appear to have had a paradox. At the same time MYGN is one of the most-shorted issues around, there were whisper (and not-so-whisper--see BoA/ML) numbers predicting a much better Q than reported. Upshot is that we may need to actually see how MyRisk does in the marketplace before a firm direction is established.
For the bulls: notice that Myriad is trying to establish BRACAnalysis as a companion diagnostic as a distinct entity, not the same as regular BRACAnalysis. Not certain to succeed, but lucrative if it does.
As usual, please keep just this one topic free of personal remarks, price predictions, newsletter promotions and the like.
Ok, I liked the YoY growth; didn't like the QoQ shrinkage. The year-end loading excuse^h^h^h^hplanation rings true, but this is supposed to be the rapid growth period for Jakafi use in MF.
I dread to think how the market would have reacted if Dr Paul had run this CC. With HH front and center, well, look at the tape. I would prefer if he dialed the accent down a bit, but just a bit (after 30 years in the US, I'm pretty sure he can set it to whatever level he wants).
Did you notice the bit about p3 results on Bari being available INTERNALLY this year? Sounds like Lily is hoping to follow the common practice of sitting on the first p3 results until a sufficient collection of them are available to support either filing or dropping out [ah, the luxuries of being a drug giant].
I see a certain inconsistency in the projected research program. It seems that EVERYTHING is moving forward, including a go-it-alone trial of a JAK1 candidate against RA. Management had previously said that there wasn't money to do that. The reasonable conclusion is that they anticipate a large amount of new money within the next 2 years. That could mean that they anticipate partnerships, early success of Jakafi against prevalent solid tumors, or take-out.
A lot more in there, but that's what I have to say for now. What do you want to point out?
If you listen to it, you can get a lot of color bearing on the response to the ASCO abstracts. The essential theme is that things will take longer than bulls might hope for.
Suppose, for instance, that the magic subgroup had turned out to be defined, in part, by an index of wasting--say weight loss or arm circumference loss. That wouldn't interact with any controversial hypotheses about disease mechanisms; it would come down to answering "Can the result be replicated?" and BANG! success or failure. But the subgroup is defined by an fairly crude indicator of general inflammation, in particular, a test that's interesting for its prognostic value but that doesn't directly show disease impact on the patient. The justification for pulling out the subgroup is a speculative connection between generaliazed inflammation and local events involved in tumor growth. The payoff may be MUCH larger, but it will require a lot more study to define.
The IDO situation is more fluid. In the cohorts discussed so far, a low dose produced a "half miracle" (there's no such thing as half a miracle) while an overdose produced just a hint of something worth fishing for. A middle-dose cohort has probably been studied, but we won't get results until the meeting. But the research needed to establish IDO inhibition as a general part of immunostimulatory cancer therapy, and the way to get a drug with little value as a single agent but great value as part of combinations onto the market will take a while.
And of course, the business problem of selling Jakafi for PV still hasn't been solved. There's a hint, but only a hint, that the results presented at ASCO will help define a strategy (some patients, perhaps, benefiting disproportionately from JAK inhibition).
But the abstracts just don't promise increased sales right away, and taking the conference broadcast as a context for them, the time frame may be closer to 18 months than to 6.
Near-term (I interpret that as 2 months or less) for INCY the candidates are revelation of the magic subgroup, readout of a third-party p2, pricing in a third major EU market or good sales. For ITMN, candidates are press coverage of ATS presentation, pricing in Spain or EU sales acceleration. Of course all of these are subject to takeover, but we won't plan on that. My impression is that ICPT got SO far ahead of itself on surprising good news that nothing near-term can make it pop.
This is likely to be connected to index option activity that is hidden in the noise. Options boutiques do strange things in the front month.
Mr Welch does not have the sort of personality that fits the program. I mean, I don't think you could get him to jump up and down with "The Miracle on Ice" on the monitor and hot peppers in his shorts. Cramer: "Would you agree that Intermune will soon have all the money in the world?" Welch: "Thank you for a very good question. I am not prepared to speculate on events that far into the future. I might be safe to say that we have funding to continue our marketing efforts for the next two quarters." The video may go viral.
I've been suggesting that a certain poster with strange options ideas ought to read "Options as a Strategic Investment," by LG McMillan. Well, I had read the second edition, and the current one is the fifth, so I decided it was time to take my own advice. And practically right at the front, there's a warning about a pitfall in one of my favorite strategies: selling puts short ("naked"). It can be incredibly tempting, when a stock has been making steady gains, to try to goose returns by shorting puts. This is EXACTLY the worst situation for that particular strategy. The options are likely to be close to appropriately priced, and in case of a downdraft, the obligation to buy either the put or the stock can come at an extremely inconvenient time. Sell puts when the market is disordered (making mis-pricing commonplace), not when it is steady.
I think pretty exactly the opposite. I don't think they "fumbled the ball in 2010." They came pretty close to approval with a data collection that technically met the requirements, but didn't hit FDA's usual standard (YES two pivotal trials, but NO both of them didn't hit primary endpoint). They came out of it with a pretty clear roadmap to approval, which they have followed. They couldn't have gotten a SPA because it would re-open the issue of whether a pivotal trial had to have survival as a primary endpoint. Maybe you could blame management for not going with stricter enrollment criteria in the CAPACITYs, but I think enrollment was difficult 8 years ago when the IFN failure was fresher and the side effects looked worse.
And whether FDA is tougher on big pharma players or not, I observe that the big guys make MUCH fatter submissions. Intermune WILL get approval, and probably fairly quickly; a big player might get run around the bush.
Early reaction will depend a lot on spin. I don't think any advisor who likes his clients (or anyone playing serious money for himself) is going to get excited about PV prospects until the actual dollar results start coming in. One of my favorite clichés about medical research is "There are no half-miracles." Preliminary highlights on the '360 trial looked half-miraculous. Is the presentation better? The promising result might get spun into something that moves the stock, since people choose to highlight cancer immunotherapy these days (Breakthroughs have been imminent in cancer immunotherapy since 1958 to my direct personal knowledge, and notice how many have stuck). I'm most hopeful for RECAP, but it's the most sensitive to spin. What difference does Ruxo make in QoL? Can physicians get worked up about it? Can all the important parties be convinced that dividing a population by modified Glasgow prognostic score is more natural or meaningful in this context than dividing by place in the alphabet?
And of course, any surprises in the third-party experiments?
I'm afraid that the marketplace has spoken, and NICE is unlikely to repeat King Canute's mistake. I can't guess when, but they will approve Jakavi.. It's risky for them as individuals to delay until after FDA decides on whether references to life extension can go on the label--they look like jerks either way that decision comes out (if they DID command the tide to stop and if FDA doesn't allow the mentions, they might not look too bad, but all 3 other combinations look awful for them)
I'm still working up my + and - cases, but I don't see any unarguable positive catalysts in the next 9 months. On the other hand, about the only negative catalyst I can see is a turning away from immunooncology. The "Jakafi for MF and PV company" would be worth something like the present stock price. So leaving out M&A possibilities, I don't expect much excitement. The JANUS trials take a lot of the possible impact away from any investigator-sponsored trials.
A week before ASCO. with much moaning about the ill-defined survival benefit shown in RECAP, recall that the business goal in doing the trial was not to show survival, but to show palliation. It would have been difficult to run a study that didn't offer SOME hope of showing a survival benefit, so that's how it was done. We still haven't seen the key results. And there is most likely a survival benefit too.
Too much belief out there that EZ is a badly-run company. Eliminating the advisory fee was A step; Replacing the revolver was probably necessary, and won't be seen as either smart or otherwise. Any move more than a token one will require evidence of either management wisdom or friendliness to owners. It wouldn't be hard, but will it happen?