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Patriot Act RIP
Now this is what I like to see!
Today, Senator Chris Dodd (D-CT) announced he'll be introducing the first shot across the bow of the unconstitutional Military Commissions Act (hat tip to Crooks & Liars). The bill is called the Effective Terrorists Prosecution Act and would, amongst other things, roll back some of the more insidious aspects of the MCA by:
1) Restoring habeas corpus. 2) Establishing a more focussed and more realistic definition of "enemy combatant". 3) Limiting the president's interpretation of the Geneva Conventions by, in part, demanding congressional and judicial oversight. 4) And, most importantly, it calls for a judicial review of the constitutionality of the MCA. I can only assume that, if successful, it could lead to an eventual repeal of the entire law.
Clearly, Senator Dodd isn't wasting any time. And apart from having an unfortunately awkward title (I know what the senator means, but it sounds like we're prosecuting effective terrorists which implies they've already effectively done something) you have to give the senator a rousing huzzah for introducing this bill now -- during the lame duck session.
I've been asked if my previous blog was a mission statement and the answer is an unequivocal, "Hells yeah, broseph!" I intend to track the demise of the MCA and the USA Patriot Act for as long as it takes. So for what it's worth, I put in some calls to some contacts to gather more details and I should hopefully have some answers organized soon.
The key to the whole thing is finding out whether the bill has a chance in hell for a vote in this session and whether the votes exist. Either way, the basic idea of striking down the MCA has clawed its way to the congressional surface and I'd be surprised if it wasn't the first shot.
So Senator Dodd officially becomes the first honored recipient of the Luther Baldwin Award for Shooting the MCA In The Arse With A Cannon (also not the most graceful title). Wear it well, senator!
CONR
The premium is insufficient, in my opinion. I have little doubt that there will be a bidding war. ~$1.2B for a platform technology that has the potential to solve delayed stent thrombosis isn't nearly enough to pay. Also look at the J&J vs Boston Scientific battle over Guidant.
Just a guess: in the end CONR will go for $1.5B+. Even that is a very good deal.
Insomnia
I can't answer the question about the size of the market for middle-of-the-night dosing; however, it appears that many physicians would consider an Ambien oral spray.
Keep in mind that this study was commissioned by NovaDel, so take it for what it is worth.
I have a small position in NVD.
>The holy grail in insomnia is a drug that works reliably even after the user becomes accustomed to it and leaves no next-day hangover.<
Agree, but do you think a rapid-acting oral spray has any market potential in the context of current treatments for insomnia?
>Personally I'd rather not expose my lungs to a synthetic agent<
That's a good point, some portion of an oral spray is inevitably going to be inhaled. But keep in mind that this is not an inhaled agent per se, the bulk of the drug absorption occurs across the oral mucosa, not the lung.
>There will be people who are wide awake at 2 am and want to take something that will be gone from their system and leave them without much hangover the following morning<
That's exactly the market I was thinking about for Ambien oral spray. It might also be appropriate for travelers. The formulation I'm looking at has a 10-minute onset of action, compared with 30 to 45 minutes for the immediate-release tablet formuation.
While I think there might be a very significant market for the oral spray, but I've been asking around about it and everyone seems to think such a formulation screams "abuse me!"
I don't really get it, but among the fashion crowd in NYC (and probably others) it's considered fun to take an Ambien and stay awake. An oral spray would be better if that's your bag.
That said, I'm not so worried about these issues in the short and intermediate term.
Speaking of insomnia: any general thoughts from any of the insomniacs on this board about the market potential for Ambion in a rapid-acting oral spray formulation?
Just looking around at various investment alternatives in the insomnia space. While it is true that getting them through the FDA might be challenging, I don't think this barrier is relevant for short- and intermediate term performance as an investment. Particularly given the enthusiasm that potential new treatment alternatives are met with.
>Giuliani takes first step toward '08 presidential bid<
I would not mind Giuliani as the Republican candidate. Although he's crass (speaking as a New Yorker), he's not in the pocket of the religious crazies and he probably has a hell of a lot more restraint when it comes to spending.
That said, Bloomberg would be my Republican of choice.
>I suppose you could have mentioned Esperion, as well. But your examples are in the infectious disease area and the cardiac area. I'm not sure this applies to RPRX.<
I chose MICU as a comparator for a good reason: they had two products (anidulafungin and dalbavancin) that had estimated peak sales of ~$500 million each, which is the estimated peak sales for Proellex and Androxal. In addition, MICU did not have a platform technology, so the $1.8 billion purchase price was largely attributable to the value placed on their two products. Again, similar to RPRX. Admittedly a different therapeutic area, but the closest comparator I can find.
Not that I'm holding my breath for $1.8 billion for RPRX. A $300 to $500 million market cap would make me jump up and down for joy. Even $200 million would be fine by me. I think the latter is an entirely reasonable expectation for 2008, particularly if acquisitions keep up at anywhere near the current pace.
>How much cash will it take to get RPRX to the point in the regulatory process where you think they will have a decent chance to be bought out?<
The company has guided $50 million to take both products through phase III and get the submission package together. How and when they raise cash will have a significant effect on the upside, as will an early sale of either drug. I doubt they will be raising all of that in January--perhaps $20 million, which will get them through '08.
>And they'll have to have some decent cash in the kitty when they start to negotiate.<
Normally true, but remember that RPRX does not have a huge research organization to support. Their administrative burn is very, very low. Once the trials complete, their spend goes down to virtually nothing.
>requiring long and complicated trials, especially for Androxal.<
Remember that these are not outcomes trials, so they really aren't long or complicated.
>But since I'm the dumbest guy on this board, you shouldn't put any value in my opinion.<
You keep saying that, but I think your posts are among the most valuable on the board.
>It could very well be argued that, given the political climate, that oncology is really THE place to be, because that is one of the few areas where politics might not rear its ugly head. (No one is calling for "safer" cancer drugs.)<
To a certain extent, I agree. No politician wants to be seen impeding cancer research. However, as you already know there is a huge furor over the cost of certain oncology drugs, and substantial debate in the academic and medical community surrounding cost:benefit for these drugs.
Dew's argument--which I agree with after thinking about it--is that there are too many drugs chasing too few dollars in oncology. Apologies to Dew if I've misstated his argument.
Regarding RPRX's business plan: I'm probably stating something that is completely obvious to you, but when and for what price the drugs get sold is a complex balance between risk and reward for both the purchaser and the target.
Provided everything is successful, the purchase price would be maximized after approval by the FDA. As you've probably noticed, acquistions frequently occur during or after phase III trials have completed and before FDA approval. There are also plenty of examples of companies with phase II drugs or even phase I that have been purchased for substantial premiums.
Put it this way: Vicuron (my favorite example since I owned it) was purchased for $1.8 billion after completion of their phase IIIs but before the FDA approved either dalbavancin or anidulafungin. Pfizer took that risk because they would have had to pay a much greater premium after the drugs were approved.
My personal preference for RPRX would be earlier sale for less money, but as they've already stated mid-2008 is their target.
>But they don't have anywhere near the resources they would need to take these drugs into pivotal trials.<
Not sure why you're stating the obvious here. Like every other biotech under the sun, they have to raise cash to carry their programs forward. The decision as to whether to dilute or partner is again a question of risk-reward.
Walldiver,
The interim results for numbers 1 and 2 will be out in December, as will the final results for number 3. Here's the list:
1) 200-patient US Phase 3 study of Androxal for testosterone deficiency in men with secondary hypogonadism
2) 150-patient US Phase 2 study of Proellex for uterine fibroids
3) 40-patient European Phase 2 study of Proellex for endometriosis
Again, although I expect positive results in these trials (given the results of the previous active-controlled trials) they will be raising cash in January or February. I'd expect many will hold off until after the financing to invest; in fact, I've reserved some cash to buy more then. Provided the results are positive, of course.
RPRX
Edited for intelligibility if not elegance.
An I-Hub member sent me a private message asking why I liked RPRX. I spent a significant amount of time writing up the answer, so I'm reposting it here. I would welcome criticism or comments.
Alternatively, you can accuse me of pumping and go back to reading all of the cut n' pasted news articles.
Like any other biotech stock, there's risks and potential reward. I feel that the equation is weighted toward the latter, but what do I know?
The risks:
Proellex fails its primary efficacy end point for uterine fibroids.
Unlikely given previous results as the 25 mg and 50 mg doses appear to provide efficacy equivalent to or a little better than Lupron and asoprisnil (which has been withdrawn). This study is vs placebo.
Proellex fails its efficacy end point for endometriosis.
Again, fairly unlikely--we already know from the interim results that there was 1 day of pain with Proellex vs 19 days of pain with Lupron. This open-label phase II study is vs Lupron.
Key risk for Proellex: endometrial thickening.
The FDA is going to be watching this closely. However, given that the 50 mg dose did not cause thickening, and it is the most efficacious dose, this might not be a huge worry. In addition, the CEO claims endometriosis is manageable through intermittent withdrawal of the drug so that the endometrium can be shed).
Androxal fails its primary efficacy end points.
There are two in the upcoming trial: testosterone levels and libido. Again, I previous trial results indicate we can be pretty confident that the testosterone levels end point will be met as they got P-values vs placebo of .0005 to .0053 in a 40-patient active controlled trial. Note that the change from baseline in testosterone with the 50-mg dose was in between the 5 g and 10 g dosages of Androgel. I think we can be reasonably confident that it will meet the libido end point as well, as long as testosterone has something to do with libido.
Androxal fails the secondary end point of "distress."
Watch the presentation for more info on this. Basically, the FDA is requiring Repros to include a "distress" questionnaire as an end point in the trial. Perhaps the dumbest FDA requirement I've ever heard. I do not understand the rationale. This is the primary risk for Androxal.
Financing
Of course, they're going to need to do a financing in January or February. I don't know how this is going to affect the stock price if the results of the three trials are positive.
Low float
There are only 10 million shares out, so it's going to be an extremely bumpy ride.
In short, I think the risk for Proellex is safety (not efficacy) and the risk for Androxal revolves around a BS end point.
The rewards:
Ridiculously low market cap.
I have no idea where this is going in the intermediate term due to the (hopefully opposing) effects of the trial results and financing. However if the results are positive, the share price should end up multiples of what is today by early to mid 2008.
Demonstrated efficacy in active-controlled trials
Two drugs with demonstrated efficacy in active-controlled phase II trials with good-sized markets. These aren't niche products and would fit quite nicely into the portfolio of, say, Organon.
If Proellex and Androxal hit their target product profile, they also have very significant advantages over existing products. See the presentation below for the spiel.
Management motivated to sell
A management that is motivated to sell. According to the R&R presentation, mid-2008 is their earliest target date.
More information
The October 2006 presentation is here: http://www.reprosrx.com/ppt/Repros%20TherapeuticsPresentationOctober2006.ppt
And if you prefer your presentation with narration by the CEO, who apparently has trained as an auctioneer, go here:
http://www.reprosrx.com/presentations.htm
The latter presentation has information on the endometrial thickness issue, so if you can stand listening to it, I'd recommend it.
>It’s hard to see why a biotech investor would not want to place a bet somewhere within this sector.<
I feel the same way about hepatitis as you do about oncology: too crowded.
The fact that IDIX did not get a significant pop after approval--despite having a perfectly good drug--supports this idea.
By the way, I agree with you about oncology.
RPRX
I think it is too opinion-based for an RMF. What do you think?
Aside from that, I'm having enough trouble finding time to keep the XNPT RMF up to date!
What I would like is some debate about something other than hepatitis. Not that I have an issue with IDIX, among others, just that every other post is about it.
J
No sense of humor
PTIE
As a past PTIE stockholder, ny personal opinion is that they're moving beyond their core competency, particularly given the qualifications of the staff they have on hand.
It'd be like me, moving from a career in biotech to a career as a lounge singer...oh wait...never mind.
PS: I'm glad they're using radioactive uranium as opposed to that depleted stuff.
>Peg, You really should be civil and stop putting words in peoples mouths and telling lies.<
I'll second that. Peg, I have some basis for agreement on some of the issues, but please stop being vulgar.
Same goes for the rest of you. Can't we have an intelligent conversation? Particularly now that shazaam has gone into hibernation?
>RPRX is getting clipped...down 15% for value shoppers.<
Very odd two days for RPRX...painful too. Someone big has unloaded.
I assume the drop was triggered by something that was said at the R&R presentation, but to everything that was presented there was old news.
Puzzling, and there was nothing that would change my mind about the intermediate- and long-term potential of RPRX.
I generally don't average down, but I picked up a lot more today while it was under $6.30.
I've always wondered what planet Buchanan is living on:
>What went wrong? Certainly, on three traditional Republican issues – strong military, conservative judges and lower taxes – the GOP remains America’s Party.<
Strong military
Unless you count wasting billions on useless F-22s and worthless missle defense systems, I'd beg to differ. The current "Republican" regime is good for military spending. An entirely different thing than being good for the military. And veterans, for that matter.
Conservative judges
If he means "conservative" in the sense of strict construction, he's wrong. Republicans have simply replaced one set of ideologues with another that is arguably much nastier and partisan to boot.
Lower taxes
Love my tax cuts, but they've come at the expense of more and more people getting whacked by the alternative minimum tax. So it's great for me (since the AMT hasn't hit me yet), but not great for the a large, and growing, segment of the population who can ill-afford the back-door tax increase.
And the estate tax? It just make the rich richer. I see no reason why the largely worthless children of the ultrarich shouldn't have to work for their money like the rest of us.
In short, they should move up the exclusion level substantially so that family businesses and farms aren't affected, and then index it to inflation. But we shouldn't eliminate it altogether. That would just create an entitled aristocracy. Something we're already moving toward.
Use any CRO but Parexel (or PAREXEL, as they prefer to be called--you're supposed to shout it).
Geoff,
I'm not a physician, but I consider a high dose 400 to 800 mg. 1000 mg is a really high dose. Before the Vioxx controversy, many physicians would have prescribed a COX-2 inhibitor becuase of the risk for GI bleeding.
You could always call your physician and ask. I'd suspect that he or she will say a proton pump inhibitor couldn't hurt. Plus, they're inexpensive, so there's not much financial impact if you get an OTC version. If you do go this route, don't bother with a prescription PPI unless your copay is lower than the cost of OTC.
I'd be curious to know what your physician says.
Painkillers
If you're going to try a high-dose NSAID, and you think you're going to be taking it for several weeks or more, do yourself a favor and take an OTC proton pump inhibitor with it. NSAID-related gastrointestinal bleeding is a serious risk.
I find it surprising that various groups get their undies in a knot over a few cases of statin-related myopathy while neglecting a very real killer.
Why should I see #36659?
Maybe I wasn't clear--a 4 mm Hg increase would yield a 20% increase in risk for death, so the effects of an incremental LDL-C lowering vs the BP increase would probably be a wash.
PFE
>The company said overall phase III data show patients taking the combination pill had an average gain in systolic blood pressure of roughly one millimeter above the two-to-three-millimeter increase found in phase II studies.<
According to data from the Prospective Studies Collaboration, each 20 mm Hg increase in SBP is associated with a 2-fold increase in the risk for death from ischemic heart disease and a slightly greater than 2-fold increase in the risk of death from stroke. The change in risk for these events across SBPs ranging from 115 to 180 mm Hg is strikingly linear, so a 2-mm increase in SBP would be expected to increase the risk for death from ischemic heart disease and death from stroke by about 10%.
Now, a 27% incremental reduction in LDL-C starting from, say, 100 mg/dL with Lipitor 10 mg alone would yield an LDL-C of 73 mg/dL. If epidemiologic evidence is to be trusted, each 10 mg/dL incremental decrease in LDL-C yields about a 10% reduction in the 10-year risk for CHD events in primary prevention patients (note: this is CHD events, not death from ischemic heart disease, and CHD events doesn't include stroke). This would yield a 27% reduction in 10-year risk for CHD events.
So as a very conservative guess, I'd say that the risk:benefit is either a wash or weighted toward the combination pill. And that's completely discounting the effect of raising HDL-C by 56%, which is likely to tip the balance strongly in favor of the combination pill. It also discounts the effect of Lipitor on triglycerides.
I can pretty much guarantee that this is the kind of logic Pfizer will use to defend the utility of the combination pill, although my math might be off. I still use my fingers to count.
My strategy for the combo pill would be to get it approved first for patients with diabetic dyslipidemia. These patients generally have very depressed HDL-C levels and are at very high risk for events.
>More than half (56%) of M.B.A. candidates say they cheated in the past year. For the study, cheating was defined as plagiarizing, copying other students' work and bringing prohibited materials into exams.<
Maybe part of the reason is that MBA students recognize that 90% of what they're learning is useless in the real world. Many consider business school as just a place to make contacts and polish the resume.
In contrast, it's pretty hard to make money as a lawyer or doctor or get a job as a scientist or historian if you don't study.
COR
The curve also serves to illustrate that as a group we are pretty good at predicting negative price movements. Would be interesting to repeat this experiment several times.
>Its not about Bush respecting you, its about posters not using slurs and venom in their posts.<
I've tried--sometimes unsuccessfully--to be polite and have a meaningful discussion. But you don't bother to respond, or you respond with "look it up on Google" or (forgive the inexact quote) "there are other miltary groups that would rank Congress just the opposite."
I asked for clarification. I was willing to review your sources. No response. Just a statement not backed up by data.
I apologize for calling Bush "Preznit Torture" It's something that I feel very strongly about. I do not apologize for calling them neo-cons. I use the label to differentiate the current regime from traditional Republicans.
RNVS
Personally, any company that claims its drug works primarily through an anti-oxidant mechanism makes me want to run screaming the other way.
Can anyone name a successful drug based on an antioxidant effect?
>I do though love reading all the posters who claim that they're "fiscal conservatives" while constantly proclaiming the "evil" of those tax cuts....how they defend their pet "entitlements" while eviscerating and excoriating the ones they don't care for. Makes for a good chuckle.<
The only "entitlement" I was defending was supporting our troops before, during, and after their service in the military.
>Oh come on Gulf....we all know that the answer to the countries problems is more taxation, bloated government, and above all else entitlements. Entitlements are like "free cash", that's why they're called "entitlements".<
I suspect I have at least as much or more than you to lose from a change in the structure of our tax code. The difference is that I recognize the need for a balanced budget. We either a) stop wasting money on ill-advised foreign adventures and corporate welfare or b) we raise taxes.
Those are the logical choices. Currently, we're spending far too much, not supporting our expenditures with tax revenue, and selling our country to the Chinese and Russians to support our spending.
How much geopolitical leverage can we have when China and Russia (not enemies, but certainly not friends) could destroy our country by refusing to buy American debt?
Republicans appear to have trouble balancing their checkbook.
>nerd seeks unsweetened blonde angtigen<
While this is nice, what does it have to do with biotech investing?
If you could, please state the investment implications rather than leaving simple folk like me to guess.
>There are other groups (military) who rate our congress and senate who would give an exact opposite view also...<
Okay. I would be happy to evaluate your evidence, and change my mind if warranted. If you could provide the appropriate links, I will look.
But please note: their methodology for grading Congress must be transparent. That is to say, they have to list all of the votes they are using to grade, clearly state their position on each vote, and provide background on how the grade was determined. Anything less is subjective.
>Yes but there is a limit...The ones who get an A from that group think there is no limit to entitlements.<
I don't think there's much difference between Democrats and Republicans in terms of entitlements. The difference is to whom the entitlements are directed. If I have to put up with entitlements and big government spending, I'd rather see those dollars directed toward the people than toward an useless F-22, a bridge to nowhere, or the politically-connected businesses that so disasterously managed our response to Katrina.
The Republicans have not shown even a modicum of fiscal responsibility in the 6 years they've controlled our government. The days of Democrats being called "pro big government" and the Republicans being for "limited government" are over. What does the evidence have to do, get up and slap you in the face?
Just saying "there are other groups...who would give an exact opposite view" is not enough. Show me the data. Otherwise your statement is just hot air.
Now I'll sit back and wait for your answer, which will undoubtedly be supported by facts.
>…Brokerage firms are nervous about a recommendation to force brokers to report to the Internal Revenue Service the adjusted basis of publicly-traded securities sold during the preceding taxable year.<
I can't wait to see E-Trade implement this, considering that they can't even handle an exchange switch. E-Trade had my cost basis for HNAB as $0.00, which makes for quite a capital gain. Even more irritating, nobody seems to be able to fix it.
>Strange how you said you were a "Libertarian" and then you go and back a group who rates Senators on how many entitlements they give out....<
One of the few reasons for government to exist is to defend the country. "Entitlements" for the people who are putting there ass on the line for us are completely fine by me.
They deserve them, and it is fully consistent with libertarian principles to support the troops.
RPRX--Huevos11
The trading on this is odd. Not that I'm advancing a conspiracy theory here, but RPRX seems to move up in heavy volume and then fall dramatically in very low volume. For example, yesterday RPRX was up to >8.30 after about 750,000 shares traded, then fell all the way to 7.85 on about 10,000 shares. Same thing happened on the day it was up to 8.54--heavy volume all the way up, then a dramatic fall on 6500 shares.
I have no idea what it means, if anything. In any case, it will all be moot once the interim results of the Proellex uterine fibroid and Androxal testosterone replacement studies and the final results for the endometriosis trial are released in December.
Not close enough for plagarism, but it definitely sounds like he's been reading the board.
No surprise there.
Or maybe we should have a contest to see how many unattributed quotes we can get into Seeking Alpha.
>Has anyone noticed that SeekingAlpha—a service that’s been picked up by Yahoo—rips off material from this message board?<
Now this is interesting. Do you have any specific examples? You should get them together and e-mail them to Yahoo.
While I'm pretty sure that it's not illegal to cut and paste from a message board without attribution, it sure would be embarassing for Yahoo to pay for analysis you can get for free right here.
>just another left-wing attack group....<
Somehow I knew you'd say that. But I would maintain that this is the only objective scorecard out there.
Please, please, do yourself a favor and look at the methodology and the bills on which the Senators on the reportcard were ranked. I think you'll agree with 90% of their positions.
>ok mister historian - did any presidents BEFORE him tell the same lies? hmmmm?<
In fact, Clinton told some whoppers as well. But that's not relevant for this election, is it? It seems that no matter what I say to you or to others of your persuasion, all you can come back with is "well, Clinton did this or that...."
And, I'll have you know I'm not a Democrat. But Clinton was a far better conservative than those in office today, even if he was a liar as well. At least he didn't kill 3000 Americans, 500,000+ Iraqis, and spend $9000 a household on a war that didn't need to be fought and only made us less safe.
And I'm still waiting for a response on the military report card.
RPRX
>I'm not sure the impetus for developing this product..seems like another version of mifepristone to me?!<
I can answer that.
RU-486 is NOT equivalent to Proellex. Beyond the obvious structural differences, RU-486 does not appear to be antiproliferative in the primate endometrial epithelium or stroma. In fact, RU-486 may elicit proliferation to a small extent. Both Lupron and Proellex are provide a fairly profound suppression of proliferation.
Source: http://www.zonagen.com/html/ppt/ZONA_BIF.ppt [slide 8]
Also, according to the most recent reliable data I can find, mifepristone just doesn't work. This is consistent with the previous source suggesting that mifepristone does not influence proliferation.
"It is known that there are progesterone receptors on endometrial implants in women with endometriosis. Small, uncontrolled trials have shown that mifepristone can decrease pain in women with diagnosed endometriosis. Yet, there was no objective decrease in the extent of ectopic endometrial implants on follow-up laparoscopy."
Source: http://archfami.ama-assn.org/cgi/content/full/7/3/219
Also, I see a only a few small uncontrolled trials of RU-486 in endometriosis and a bunch of reviews claiming it has promise. Seems a very bold statement to me to say that "RU-486 is an equivalent generic."
Also, from a strictly practical point of view:
1) Why would TAP and Schering have spent hundreds of millions on asoprisnil if there wasn't a market in endometriosis and uterine fibroids?
2) As you've alrady noted, RU-486 carries a considerable stigma. That alone will push women into other drugs.