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JAV
Just talkin' to myself.
JAV was up over 14% today (on high volume), in addition to 12% or so yesterday. Suggests that someone is betting relatively big that Dyloject will get the regulatory nod in Europe and/or that the intranasal ketamine results are positive.
And/or a bunch of stupid traders jumping on one of the few bright spots in the biotech industry.
In any case, still waiting for aforementioned events. I'm thinking there will be significant upside from here if both are resolved positively. I'm fairly confident both will be positive: 1) Dyloject ain't nothin' more than injectable diclofenac (which is already on the market) with some serious convenience and patient comfort advantages--it's administered as a bolus rather than as a half-hour infusion, plus it's non-irritating in comparison to the current formulation.
And the intranasal ketamine; well, snorting ketamine is bound to be highly effective. I wonder if they'll market it to consultants who need a rapid-acting anesthetic to get through slide reviews?
JAV
Up another 6% today. Too bad the rest of my portfolio is being terminated.
Edit: okay, 10% now.
>Is the "extension of PII" for fibroids, just that, added time to ensure effectiveness and safety?<
The extension has always been planned. It is very common in all clinical trials to roll patients over from the double-blind phase into a longer-term open-label phase to assess long-term efficacy and safety.
I have no idea what management's plans are. I suspect that they will go it alone to maximize the value of Proellex in a sale. Although as an investor I'd prefer a quick profit, some of the management have devoted 20+ years to this company and are holding stock at much higher prices; I doubt they'll settle for $20 share in a sale, nor do I think they're going to let big pharma capture most of the Proellex sales for a puny royalty. Again, not what I'd like to see but I can understand their viewpoint.
RPRX
This press release hides some good news. I understand there was some talk about a second phase II trial for Proellex to evaluate alternative dosing schedules. Looks like they're going straight to phase III.
>Good companies are always searching for ways to cannibalize their sales!<
Normally I'd agree with that. There are plenty of instances where--at least in a portfolio sense--multiple drugs from a single company in a single indication have led to an overall expansion in sales. It's never 1+1=2; more like 1+1=1.2. (Which, by the way, sucks for reps if they only carry one of the drugs). Companies with multiple hypertension products in their portfolio are good examples of this.
But MS differs from hypertension. The market isn't expanding, and there's no way to expand it by increasing awareness. Although I'm sure there's some wiggle room for expanding profits by moving more expensive newer drugs to earlier-stage patients and shifting older, less efficacious and/or less well tolerated agents up the treatment ladder to more advanced patients, the MS market is more or less fixed in terms of patient population.
Gotta love a good panic.
What does sub-prime lending have to do with biotech?
ALTU
Dew,
Agree that ALTU isn't exactly cheap. It's not a swing-for-the-fences stock. All I'd ask of it is to recover to $20 or so over the next few months. Certainly not a long-term holding at these prices.
The royalty rate from DNA is "double-digit." $110 million in milestones, only $15 million upfront.
Not so worried about a VRTX sale in the short- to intermediate-term. I assume that--in the absence of any major events at VRTX--they'll hold to reap some of the profit.
JAV
Up 6% today. MAA approval for Dyloject should be this month or next; results for the intranasal ketamine product should be out over the next couple weeks.
ALTU on sale.
Anyone have any opinions? It's down close to 25% from its high; they got a great deal from Genentech for ALTU-238 (extended-release HGH) and ALTU-135 seems reasonably low-risk and with substantial advantages over current pancreatic enzyme replacement therapies.
I'm in for a couple thousand shares in the mid-15's but am considering buying much more.
Some information here from everyone's favorite biotech journalist:
http://www.thestreet.com/newsanalysis/biotech/10333370.html
Hey that's like 3 blocks from my apartment. I live in South Street Seaport. Looks like home to me.
JAV
Report sent to Dew for distribution.
>under-recognized, under-valued, and mis-understood opportunity<
Funny, that's how I describe myself in my online personals ad.
>If Provenge gets the nod--DNDN could quadruple to $16 based on a 4 times projected sales of $500 million in the first year.
If it is rejected--I take a 50% hit and have to wait another 18 months or so for the other 500 patient trial they are doing to be completed.<
The problem with your calculated gamble is that this is exactly the same calculated gamble that every hedge fund, individual investor, their parents, grandparents, and colleagues are taking with DNDN.
I'm guessing the potential upside is much, much smaller--a buck or two--and the downside might be greater.
Doing the same thing as everyone else is never a great way to make money. Just my opinion, of course.
AIS
Does anyone have access to Punk's AIS report?
Very curious about their rationale for the rather ambitious $3 price target.
J
AIS
Started at buy by the Punk.
Not sure why, though. Any insights?
I’m quite clear on multiple-compartment PK modeling. However, I just need a definition of accumulation half life, preferably in Engrish. I’d suggest:
“The time required to reach half of the theoretical maximum concentration of a drug in a particular tissue.”
At least that’s my interpretation of the math.
This is actually relevant, believe it or not….
Apparently...I've been searching for a definition on Google and I can't find anything...I have never heard of such a thing. Elimination half-life yes, accumulation half life no.
Can anyone define 'accumulation half life?'
...and that's why I've been on a shopping spree this week.
Quote of the week:
"He has had a couple of patients in the past who have ruptured their balls at home while sitting on them and doing exercises."
http://finance.yahoo.com/career-work/article/102512/The_Ball_in_Your_Cubicle
JAV
Hit a 52-week high today.
I have a half-finished RMF for JAV. Anyone still interested?
DYAX
>So is it time to accumulate some DYAX after yesterday's pullback?<
I haven't personally bought yet, but as long as you buy slowly and carefully I think DYAX is a good value. That's not to say it couldn't plummet from here...which is why when/if I do buy, I'll purchase in multiple transactions.
DYAX has a good corporate presentation on their website, last I checked. Their CEO is easily the most boring man on earth (a good thing in a CEO, in my opinion), so be prepared.
DYAX
Every once in a while, I find something intelligent on Yahoo.
Henr(y) has been having his way with Henr(i) for some time. Henry has readily admitted that he regretted the HAE deal with GENZ, but it was needed when DYAX was struggling to get going.
The mistake for GENZ was giving up CTS rights. While DX-88 in CTS can be a blockbuster just because of sheer patient numbers, DYAX cannot charge an unlimited amount for it as it can for an orphan such as HAE. So, HAE patients will pay through the nose for DX-88 until CTS is approved at which time price will drop.
DYAX is still happy because it has 100% rights to a blockbuster market in CTS, while GENZ is left with 50% of an HAE market that has imploded. GENZ recognized the inevitable and bagged it now before spending any more money on launching HAE. They took some equity declared victory and went home.
DYAX
I tried to put a limit order in for DYAX at $3.50 last night; unfortunately my good friends at E-Trade weren't accepting online orders.
Although I am not so sure about the long-term prospects for DX-88 in HAE, I think there's plenty of room for a double for DYAX, particularly if the on-pump trials show positive results.
>Guess a $4M cash ball from outer space landed in SPPI’s parking lot.<
That happened to me once, so although unlikely it is within the realm of possibility.
>You never commented on AEMD before.<
The fact that you think I didn't comment suggests that you are stopping by to spam the board without reading the responses.
Both Dew and Biowatch have also commented before, I believe.
Just a suggestion: try an added value post. Why do you like AEMD, what's the market potential, what is the science behind a "blood filter," why do they think a blood filter can do any good whatsoever when, as Biowatch indicated, viruses frequently reside in tissues.
By the way, a "blood filter" is hardly a new idea. It's called apheresis, and it's been tried for HIV and is in common use for a number of other diseases, including IBD and rheumatoid arthritis. It has also failed spectacularly for macular degeneration. See RHEO. You do know RHEO, right? You should if you have money on AEMD.
Outsiders are not unwelcome. Although I do not moderate this board, the fact that your post was deleted suggests that repeated spamming without useful comment is not really welcome. I don't mind an occasional "Stock X is up X% today" or people crowing about being right about a stock. But repeated useless posts are kind of a waste of everybody's time.
AEMD
I have a question: how many times do we have to comment on AEMD and look at this stupid chart before you stop. You have your comments.
Ah, the famous Croumag negative indicator...just posting this as a public service. Run for the hills!
VSGN
“I think most investors that still have doubts about the Celacade technology effectiveness should re-read the announcemnt of VSGN concerning the results of the SYMPADICO trial.”
DSCO
"If you feel bad that you sold at $4.1. You will feel worse next week if you do not buy tomorrow under $5..."
NFLD
"Buyers are lining up, no sellers to be found, and the large short ratio is getting close to panic mode..."
CRIS
"I think the January upside effect for CRIS is about to start any day. This time I expect the upside will take us beyond $5 by Springtime. With some luck, repatriated money could also bring in more solid partnerships and even higher pps... We shall soon see..."
GTCB
"$1.28, $1.38, or $1.45, who care ?? You could be looking at an easy double in a month or so."
>Good point, but that would only get infected cells circulating in the blood, not infected intestines, lungs, liver, etc<
That's easily overcome by solubilizing the subject.
More pointless jabbering from me...
Although I agree that there's not much hope a blood filter is going to stop a viral infection, note that the virus does not necessarily have to be in the extracellular space to be picked up. If they made a column with an antibody to a viral protein that is expressed at the cell surface during infection, those cells would be captured as well.
I think we're both thinking about the same thing. Perhaps I should have said "the ultimate effector of a particular disease process" rather than "particular pathway." If I can make that amendment, then hemophilia treatment with FVIII fits the bill exactly.
I'm not sure that use of anti-TNFs in inflammatory diseases fits the key precept as TNF is not the only (or even the primary) mediator of inflammation. Moreover, as you know, most intra- and extra-cellular signalling pathways are a cascade; inhibiting TNF production upstream could have lots of unintended consequences.
Is it going to be administered chronically or peri-procedurally?
It's a good thing I'm self-employed, because I just spent the last 15 minutes pacing back and forth trying to figure out if there was a clinical situation or condition in which a VIII-targeted agent would be preferable to, say, a direct thrombin inhibitor.
I really can't think of any reason for this product, other than to have something novel. In clinical terms, inhibiting factor VIII is *probably* more than sufficient to prevent thrombotic events. However, in practical terms, doctors are going to question the value of inhibiting only one "branch" of the coagulation pathway when they can target thrombin directly.
Part of this goes back to one of the key precepts of modern pharmacologic design: get as close to the ultimate effector of a particular pathway as possible. I think most physicians are firm believers in this concept.
A parallel can be drawn with the antiplatelet market. The platelet aggregation pathway has a similarly branched structure. Thienopyridines (eg, clopidogrel) act by irreversibly blocking ADP receptors on platelet cell membranes; aspirin acts on a different branch by inhibiting COX-mediated prostanoid production. *Only* GP IIb-IIIa inhibitors act on the final common pathway of platelet aggregation--transition of the GP IIb-IIIa receptor from inactive to active form. In other words, both thienopyridines and aspirin can be bypassed, but GP IIb-IIIa inhibitors cannot.
Again, in practical terms, the GP IIb-IIIa inhibitors have made a lot of noise about this fact, and--until bivalirudin came along--the marketing was working quite well. I see something similar happening with a FVIII inhibitor vs direct thrombin inhibitors or even warfarin, eg a salesperson for the Medicines Company might say "why would you inhibit FVIII when you can inhibit the final common pathway of coagulation?"
Sorry for the long answer. I realized it has been about 3 weeks since my last value-added post, so I wanted to say something intelligent for once. My next intelligent post will occur on March 5, 2007.
Incretin mimetics
If anyone cares to get up to speed on these agents, there's an excellent (although obviously sponsored) article on incretin mimetics here:
http://www.amcp.org/data/jmcp/Sept_suppl.pdf
VIII is not an obligate component of the coagulation cascade, eg, it can be bypassed (thus FEIBA: Factor Eight Inhibitor Bypassing Activity).
On the other hand thrombin (IIa) is absolutely necessary for coagulation, as is Xa.
Think of it like a tree with coagulation initiators at the top and the coagulation event at the base of the trunk. Inhibiting VIII is like cutting off one of the branches; inhibiting IIa is like cutting down the entire tree.
PaulaN,
I found this image of the Byetta LAR needle on the AMLN website.
It's true that needle size doesn't appear to matter much when you're talking about the difference between 31-gauge and 30-gauge, but this looks like it might hurt.
>You are not informed on the advantages of Byetta or LAR over their competitors.<
You're right...I'm not very well informed on diabetes.
>Does anyone have an opinion on what would be more popular: once-a-day pen injection (Novo) or once-weekly with traditional big gauge needle (Exenatide LAR)? TIA.<
Once-a-day will always win over twice daily, so liraglutide will clearly beat Byetta in its current formulation. If LAR has to be administered by an HCP then it is DOA from a reimbursement standpoint. It's open to question whether the needle gauge will scare some patients off...I have some experience in this area and the literature on injection site pain is limited.
>XNPT<
Yes, you are completely correct.
XNPT
One candidate down, one to go.
Not a bad up-front for a gabapentin analog.
NEW YORK (AP) -- British drugmaker GlaxoSmithKline PLC and XenoPort Inc. said Thursday they will partner to develop and market a XenoPort drug candidate to treat nerve pain and Restless Legs Syndrome (RLS).
XenoPort shares hit a 52-week high of $30.37, and were up $4.71, or 18.7 percent, to $29.95 in morning trading on the Nasdaq at more than four times their average trading volume. Shares have traded between $15.50 and $27.75 the past 52 weeks.
Under the exclusive agreement which is subject to U.S. antitrust review, GlaxoSmithKline will pay XenoPort $75 million up front for worldwide rights, with the exception of certain countries in Asia, to XP13512, an improved form of the nerve drug gabapentin.
XenoPort is also entitled to up to $65 million in development milestone payments, $210 million in other potential development and regulatory milestone payments and up to $290 million in potential sales milestone payments. Maximum milestone payments depend on getting drug market approval to treat neuropathic pain and RLS.
If XP13512 is approved for sale, XenoPort is also entitled to royalties.
The drug candidate is currently in late-stage clinical trials for RLS and in mid-stage clinical trials for neuropathic pain. RLS is a nerve disorder in which the limbs -- most often the legs -- tremble or twitch uncontrollably.
U.S. shares of GlaxoSmithKline rose 54 cents to $55.89 on the New York Stock Exchange.