JAV: Volume picking up. Price strength starting to look good as well. This is likely related to their announcement earlier in the week of the completion of patient enrollment of the last of the pivotal P3 trial for Dyloject in USA. This is a straightforward study with the results probably now in the bag.

http://biz.yahoo.com/bw/080916/20080916005263.html?.v=1

Javelin Pharmaceuticals Completes Patient Enrollment for Second of two Pivotal Phase 3 Studies of Dyloject(TM)
Tuesday September 16, 8:00 am ET


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Javelin Pharmaceuticals (AMEX: JAV - News) announced that it has completed patient enrollment in the second of two US pivotal Phase 3 studies for its injectable pain drug, Dyloject(TM) (diclofenac sodium). This pivotal clinical study evaluated Dyloject in patients with moderate-to-severe postoperative pain following elective orthopedic surgery. A previously completed and successful US pivotal study evaluated Dyloject in patients suffering from moderate-to-severe postoperative pain after elective abdominal surgery. The Company is planning to file a New Drug Application for the treatment of acute postoperative pain in 2009.
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Dyloject is being marketed in the UK and Javelin expects to file for marketing approval through the mutual recognition process in a number of additional EU countries during 2009.

About the Orthopedic Efficacy Study

A total of 242 postoperative elective orthopedic surgical patients completed this multicenter, placebo- and comparator-controlled study. They received one of three dose levels of Dyloject(TM) (18.75, 37.5 or 50 mg IV every six hours), one of two dose levels of IV ketorolac (15 or 30 mg every six hours), or IV placebo. Patients with moderate-to-severe pain following elective orthopedic surgery were eligible for treatment for up to 5 days. The primary measure of efficacy was the Sum of Pain Intensity Differences (SPID) as measured on the 0-100 mm Visual Analog Scale (VAS). In this double-blinded study, patients received treatments whose identity was not known either to them or their investigators.

And You just proved I MAY need a hearing aid."

Bridgeofsighs already did that for me. Watching Robin Trower play that rock standard led to a great waste of about an hour of my time on youtube. That IS my cup of tea (a generational thing, I suppose). Thanks for the R&R reminder Bridgeofsighs.

On the topic of the prospect of short selling constraints, would someone with better market understanding than me try to explain the possible scenarios of what would happen with the short positions already out there if new short selling were banned? Would the owners of the naked positions just cover and close out? Any speculation regarding what the new rule would do to the price of a heavily shorted stock?

regards,

aj

PS-PL1, thanks for the laugh on Emmitt Smith; a great back (if not Jim Brown reincarnated) but lousy color man.

"Leopards never change their stripes(did I say that right, Dew??) LOL!!!!

It's "tigers never change their stripes", Leopards ave spots.

Whatever you are itstheoxygen, your not a taxonomist!

aj

Reclast and the competition:

In our clinic, reclast is being used differentially with patients who have a) reflux issues and/or b) dementia issues, both of which would lead to lower compliance of taking Boniva, which appears to be the preferred oral osteo med. There have been no concerns about A-fib among the clinic doc's, in fact, the most closely watched side effect is kidney function, so creatinine levels are drawn for the reclast patients.

Remember, this isn't me doing the prescribing, I'm a Ph.D., and we have 3 geriatricians who each have their own predilections with regards to prescribing.

Cost is, however, a likely influencing factor because reimbursement for the clinic is much higher for the reclast injection vs. handing a presciption. The cost to the patient with medicare is approximately the same if they don't have a secondary ins./part D coverage.

aj

"Amgen's osteoporosis drug data meets expectations"

I follow this drug competition with modest interest. Our clinic has evolved from using the variety of weekly/monthly oral meds to reclast and I can say that the NVS rep(s) have developed a close relationship with our hospital-based geriatrics clinic so that all of our satellite clinics now send their patients to us for their reclst injections. I know one particular rep well and will have to inquire as to her opinion/NVS opinion regarding this dwevelopment.

With this data, will there develop, effectlively, a duopoly for osteoporesis treatments?

aj

Dub, as we share an intense interest in Alzheimer's on many fronts, would you care to share with me the sites you uncovered, if you've logged and/or otherwise captured them?

Feel free to contact me privately @ avramj@sbcglobal.net

thanks in advance

aj

VAR v. ARAY

Although I thought the technology was better for ARAY (and foolishly thought that growth would be handled in a business-like manner), the market clearly likes VAR better. See the following link:

http://finance.yahoo.com/echarts?s=VAR#symbol=VAR;range=1y

Re: ZGEN v CAMH

I'm happy to respond. The parallel has its limitations but you see how similar the situation really is.

"a) What was the price differential for the CAMH product?"

CAMH produced a medical device for diagnostic purposes, not a drug. There was no previous device that measured MTWA that was reimbursable under medicare (getting an NCD from medicare is what brought me to the CAMH story) with the CAMH device essentially paying $240 per stress test (versus about $130 for a typical treadmill). so there would be no price differential per se, but rather a price incentive for cardiologists to start using this test (which also, BTW would give more than ample EKG stress test data) rather than the old school treadmill stress test. Capital equipment cost remains about $30K for a unit, but CAMH is now trying to lease the damn things, without much success.

"b) What was the risk rate in the original market?"

Again, not a very good analogy, but with some key similarities. ICD's had been placed based mainly on Ejection Fraction criteria rather than risk stratified by MTWA status. If a patient is MTWA negative, they have a 98% chance of no sudden cardiac arrest event in the following year. The whole idea of getting cardiologists to use MTWA was to save all of the unnecessary ICD placements. There have been analyses published that only one in 17 ICD actually saves lives, and fully 1/3 of all candidates who meet EF criteria are MTWA negative. There have also been several studies looking at the number of ICD failures as well as the Fidelis lead problem with the MDT device. One would think that placing an unecessary ICD into a patient with faulty leads without first checking out whether or not the patient actually needs the damn $50K device would be a no brainer!

"c) What was the eventual market penetration?"

For CAMH's units? It's about 1/10 of 1 percent at the present time. with very little prospect for any change. Organized cardiology has largely ignored MTWA on all fronts.

aj

ZGEN-"One of my suggestions to ZGEN would be to work with not just the surgeons, but the guys who have to treat the patients sickened by b-thrombin - the hematologists. Among other things it would be a lot harder to tell the hematologist that the data was weak."

"And of course at some point the lawyers will figure out there is easy pickin's - and there will be one or more big lawsuits which should do a lot to change minds.'

These are arguments that sound eerily like those put forth by all of my CAMH long friends who thought that talking up Microvolt T wave Alternans Technology with general cardiologists in addition to the electrophysiologist would help sell Heartwave units.

Also, we ALL thought that with all of the faulty ICD's going into people who never needed it that lawyers would be drooling at the prospect of cases where unecessary ICD's were placed, caused harm, and the EP never conducted the MTWA test showing the patient was at very low risk for Sudden Cardiac Death.

I'm not saying that ZGEN's rethrocom is a no go, but xrymd's post is cautionary as far as I'm concerned.

aj

OT: More biotech Humor.

Thanks ghmm, I'm printing that one out and hanging it next to this, which is in one of my offices.

Why God never received a PhD

He had only one major publication.
It was in Hebrew.
It had no references.
It wasn't published in a refereed journal.
Some even doubt he wrote it by himself.
It may be true that he created the world, but what has he done since then?
His cooperative efforts have been quite limited.
The scientific community has had a hard time replicating his results.
He never applied to the ethics board for permission to use human subjects.
When one experiment went awry he tried to cover it by drowning his subjects.
When subjects didn't behave as predicted, he deleted them from the sample.
He rarely came to class, just told students to read the book.
Some say he had his son teach the class.
He expelled his first two students for learning.
Although there were only 10 requirements, most of his students failed his tests.
His office hours were infrequent and usually held on a mountain top.
No record of working well with colleagues.

aj

OT: PTSC, PL1, I know the PTSC story well; it is/was a favorite of one of the CAMH die hards a couple of years ago. By the time I heard of it, the stock was well past it's peak and back down to about 40 cents. I've tracked it's recent spike to 60 cents, but the current 25 cents is more than it is really worth. With close to 1/2 billion shares outstanding and PLENTY of stock option grants to the insiders continuing, this one won't ever find anything close to a buck again. The patent profile and trolling activity will dry up as that type of business evolves way too quickly for a co. to rely on, and there will be MANY bag holders.

I called it a quasi-scam because they DID hold some relatively important patents for a selective few manufacturers, but this is an issue that is fading fast. They can't manage better thatn 6 digit quarterly income (less even than my bag holding CAMH), and the patent licensing income is starting to fade already.

Again, congrats on your balls, I would guess that metastatic cancer provides some ability to stare down risk and laugh your ass off!!

Be well, and stay well

aj

OT: PTSC

PL1, you actually "played" Patriot Scientific and won???? I've gotta start looking at your picks; that was and remains one of the biggest quasi pump and dump scams I have ever seen.

You have chutzpah to be dabbling in a co. like that, congtrats!!

aj

gfp927z, I am personally hurt that you did not include JAV on your "other" possible buyout candidates (although you did say some others). ;0

aj

PS: The phone lines at Javelin are open, Driscoll will personally take your call.

NGNM: Noble Financial Web presentation for any who would like to eyeball the two principals driving the growth of this co.


http://hosted.mediasite.com/hosted4/Viewer/Viewers/Viewer320TL.aspx?mode=Default&peid=d1e3b760-7d83-4d0a-86c1-82908ba4ba0c&playerType=WM7&mode=Default&shouldResize=true&pid=6b1df466-f8b8-4c10-9dfe-ece5588d50fc&playerType=WM7

Of great interest (to me at least) is Bob Gasparini's mention that there will be a PR soon about the CRO section of the business. This is either the co. inking an exclusive P3 deal that follows the P2 work already done, with the P3 study on the order of 10-20 times larger (if memory serves from prior PR's) or the announcement of their second independent CRO deal with a pharma.

Toward the end, Steve Jones mentions that they are close to announcing a new exclusive genetics testing product, and later, Bob Gasparini, during the Q&A discussion of KRAS, discusses how in addition to KRAS, ERCC1 and TS variants also play an important part in determining responsivity and that they were close to announcing an exclusive deal to provide these tests.

aj

Fairly good week. Too bad we couldn't break through $3, but we're showing some signs of life. With the money manager mgmt types we have with Driscoll and Kiernen, I wouldn't be surprised that smart money is moving this thing up, forming a new base before they publicize their partner deal.

Still need this to get back to $5 and change before I'm above water, but now that prospect looks pretty good. The name of the game will soon be how long the co. holds before selling and how much of a run we get after US approval of Dyloject.

aj

Re: Topamax. I figured it was something along those lines and that the co. up for sale really didn't have anything that would be patent protectable, but I've learned that it is better to say nothing and be suspected the fool than to say something and be revealed the fool (especially around here!)

aj

Re: Once-a-day Topomax right purchase as a sucker bet.

I'm certain that I don't know and won't show my business naivete by offering WAG's. I'm sure that I nibbled on the idea for the same reason that the receiver is dangling the prospect of buying the rights. The potential for continued topirimate use is high.

Damn curious about your answer, though; coming to this board has been a consistent classroom for this clinician.

regards

aj

"One of the pieces of intellectual property for sale is its lead product, SRx-502, a once-a-day version of a branded drug that currently has more than $2 billion in sales despite twice daily dosing and an unfavorable AE profile. [The branded drug is JNJ’s Topamax.] A clear clinical pathway for SRx-502 has been defined by the FDA for a 505(b)(2) regulatory submission. A successful bidder may make the NDA submission in 2Q 2009 with the remaining clinical trials expected to cost $7 million.

A VERY interesting observation, if true. Topomax is used frequently off label in psychiatry, and gaining converts all of the time for issues related to disinhibited behavior and/or other dysexecutivism. My clinical observations (and those of my psychiatrist colleagues) is that patients either have ALL of the topomax side effects (and therefor no efficacy because the side effects shut them down) or they respond to the medication therapeutically with no or little side effects.

Too bad I don't have $7 million sitting around gathering dust.

aj

JAV:

Javelin Presents Successful Pivotal Phase 3 Secondary Clinical Results for Dyloject(TM) at the 12th World Congress on Pain


http://biz.yahoo.com/bw/080821/20080821005226.html?.v=1

GLASGOW, Scotland--(BUSINESS WIRE)--Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer of novel products for pain management, today presented new and successful secondary endpoint data from a previously announced pivotal Phase 3 study of Dyloject™. At the 12th World Congress on Pain, held in Glasgow, Scotland. Dyloject was launched in the United Kingdom in December of last year and this year received Scottish Medicines Consortium approval.
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The newly-released secondary endpoint data extends clinical evidence that intravenous (IV) Dyloject offers safe, efficacious and well-tolerated pain relief for abdominal and pelvic surgery. Patient global evaluation scores and related measures of efficacy at 24 and 48 hours were statistically significantly higher than placebo for all three arms of the study: Dyloject 18.75 mg and 37.5 mg and the active comparator ketorolac 30 mg. Compared to the ketorolac group, the Dyloject groups had a lower incidence of thrombophlebitis, and numerically fewer adverse events associated with postoperative bleeding.

Javelin’s Chief Medical Officer, Dr. Daniel B. Carr, and colleagues made four additional presentations. Dyloject given IV in clinically relevant analgesic doses to healthy volunteers in a Phase 1 study produced minimal interference with platelet function (ability to clot), reaching only the upper limit of normal. Similar small effects were seen with an oral diclofenac comparator, Cataflam®. In contrast, IV ketorolac and oral aspirin markedly disrupted platelet function as measured by PFA-100 collagen-epinephrine closure time. Similar findings were observed with collagen-ADP testing. The Phase 1 and pivotal Phase 3 results presented today add to prior pre-marketing and early post-marketing experience that Dyloject, a balanced COX-1 and COX-2 inhibitor, poses less risk of bleeding than predominantly COX-1 inhibitors such as ketorolac and aspirin.

Two additional presentations at the World Congress focused on Rylomine™ and another featured Ereska™, respectively, Javelin's intranasal morphine and ketamine product candidates.

“We are very pleased to have had five Javelin posters accepted for presentation at this prestigious World Congress on Pain meeting. Especially timely are the presentations on Dyloject demonstrating its safety, rapid efficacy, and convenience of use as it nears its ninth month of marketing in the UK and, more recently, Scotland. We had enthusiastic physician turnout at our Congress booth and presentations. It's been a very positive week for Dyloject and Javelin," stated Dr. Carr.

"Ereska™"

Not sure if I've just not paid attention, but this is the first time I've heard the co. give a trade name to PMI150.

Overall, good to have some good news to bolster us a little. We have been stronger than the one prediction that we would be dropping to below $2 without sig. sales and without a sig partnering deal. I'm becoming cautiously optimistic that mgmt has righted the boat and will bring this puppy in.

aj

NGNM:
"How come their website has a .ORG suffix? Are they a non-profit? :- )"

LOL, The CFO is, from what i can gather, a shrewd FL investor with enough knowhow to pull off being a little of everything for this co. He and his group are the largest shareholders (one of the reasons I like the co. and stock) and he's recruited a CEO who is well known in the lab industry who has put together a very good team. There is no doubt that this team is here to capitalize on the growth of genetics testing in cancer, and they will build a lab co. that will be worth much more than it is now before they put a "for sale" sign on it.

I've had a running conversation via e-mail with Steve Jones the investor and current acting CFO. He has since curtailed the discussion on advice from the co. lawyers (this last quarter) as they are concerned about SEC disclosure. Steve was quite upfront with me until that time about financing. You might recall a question I had put to the group here about rating the various ways to finance growth (eg. SEDA's PIPE's Secondaries, etc.) The question came from one of those conversations.

I think that NGNM is now in a position to offer some small private CLIA labs some stock options for joining them, and growth will be via acquisition and merger in that manner.

My impression is that Jones and Gasparini are interested in growing the co. to somewhere in the $200-300 million revenue range and then will try to sell it to either Lab Corp or Quest.

regards

aj

Re: KRAS
One of my favorite microcaps is a clinical genetics lab, Neogenomics. I believe that they are already finding a way to provide testing fro KRAS, as it is noted in the following local news piece about the growth of their business.

http://fortmyers.floridaweekly.com/news/2008/0806/business_plans/029.html

Might be worth a look, for those who like small speculative businesses, with huge growth potential. The co. has done very well since it's public inception in 2006 and my interactions with mgmt have been quite positive. They are looking for small labs to band together against the big 2 "blood brothers" and they provide excellent service with record turnaround times for their lab results. They have a "tech only" Flourescent In Situ Hybridization (FISH) product that allows the individual oncologits or pathologist sending them the sample to make more money; it's a popular product.

http://finance.yahoo.com/q/is?s=NGNM.OB&annual

aj

Update on AD drugs in the pipeline.

I have been very preoccupied with work on the AR chapter of the American Foundation for Suicide Prevention (AFSP) for the last couple of weeks and didn't have time to respond to the list of P3 trials for AD drugs. I wanted to add the following, FYI:

Lupron; Voyager Pharmaceuticals (a private co.)

More information can be found at their site:

http://www.voyagerpharma.com/voyager/index.cfm

OT: Anyone interested in our AFSP work can e-mail me at avramj@sbcglobal.net. Put AFSP in the heading so I don't jettison unrecognized posters.

aj

EARNINGS FOR Q2 ARE OUT!!

http://biz.yahoo.com/prnews/080815/mo882.html?.v=1

Minera Andes reports net income for second quarter of $0.05 per share
Friday August 15, 12:49 am ET


TSX: MAI
NASD-OTCBB: MNEAF

SPOKANE, WA, Aug. 15 /PRNewswire-FirstCall/ - Minera Andes Inc. (TSX-MAI and US OTC: MNEAF) is pleased to report net income of $8.9 million or $0.05 cents per share in its second quarter of 2008 financial statements. For the six months ended June 30, 2008, Minera Andes recorded net income of $7.2 million or $0.4 cents per share. Our financial statements are available at www.sedar.com.

Minera Andes' net income is derived from Minera Santa Cruz S.A.("MSC"), which is owned 49% by Minera Andes and 51% by Hochschild Mining plc. ("Hochschild") (HOCM.L: Reuters and HOC LN: Bloomberg - London Stock Exchange). MSC operates the San Jose silver/gold mine in southern Argentina, which had its first quarter of positive earning from silver and gold sales following the commencement of production at San Jose last year. Hochschild is the operator of the San Jose mine.

Allen Ambrose, President of Minera Andes said, "This is a milestone event for Minera Andes, to report a significant net income in its financial statements. Showing net income is the next step as we transition to a producing company with a growing silver and gold asset. With expansion underway to double its current rate of production by year-end, it is estimated that the San Jose mine will join the ranks of the top ten primary silver producing mines in the world."

Commissioned in June of 2007, the San Jose mine is operating in 2008 at full production or approximately 750 tonnes per day.

As previously reported, silver and gold sales in the second quarter, totaled $63.2 million. Over the past year, San Jose's total sales have been $74.4 million. The averaged weighted sales prices were $901/ounce of gold and $16.47/ounce of silver. San Jose's silver and gold sales are unhedged. Second quarter 2008 sales of silver and gold are higher than normal because some of the metals produced in the first quarter of 2008 were sold in the following quarter and we are presently mining ore that has a higher silver content.

Production

San Jose's silver production rose in the second quarter compared to the first quarter. Silver production was 1,093,000 ounces, compared to 968,000 ounces in the first quarter. Annualized, second quarter silver production is running at approximately 33% above the average grade of the reserves in the original mine plan. During the life of the mine it is anticipated the gold and silver production will be in line with the mine plan. Gold production in the second quarter was 12,410 ounces, compared to 12,140 ounces in the first quarter.

Mine Expansion Underway

Work continues at San Jose to double production rate to 1,500 tonnes of ore per day by the end of 2008. At this rate, the mine is estimated to have annualized metal production of approximately 120,000 ounces of gold and approximately 6 million ounces of silver. Underground infrastructure continues to be expanded, and construction is underway to increase capacity at the processing plant.

Allen V. Ambrose, Minera Andes' President, who is a "qualified person" as defined by National Instrument 43-101, is responsible the information used in this news release and has supervised the preparation of the information and reviewed all information used in this news release.

Minera Andes is a gold, silver and copper exploration company working in Argentina. The Company holds about 304,000 acres of mineral exploration land in Argentina including the 49% owned San Jose silver/gold mine. Minera Andes is also exploring the Los Azules copper project in San Juan province, where an exploration program is underway to define a resource and to prepare a scoping study. Other exploration properties, primarily silver and gold, are being evaluated in southern Argentina. The Corporation presently has 189,456,935 shares issued and outstanding.

'Did CAMH just have a CC with no Q&A? That’s extremely lame.'

Shareholders have contacted me personally to inform me that they called and called and the calls were ignored.

I have suggested that they report this to the SEC.

Lame isn't the word I'd use, more like fraudulent. I'm now officially a bagholder who's pissed that the co. has squandered their opportunity by signing an unenforceable deal that hung them out to dry.

aj

Re: IDIX. Downgrade based on pure valuation? It's had one helluva run.

aj

"i have my doubts about almost all the AD drugs presented at ICAD."

Masterlongevity, I am truly curious, which drugs do you see as holding promise?

aj

ELN/BIIB "He told me that many neurologists give tysabi as the last resort when all other options fail anyways. Its either 2/32000 chance of getting PML (which might not be fatal if caught early since those 2 patients are still alive) or being in a wheelchair for the rest of the life."

From my experience, if the drugs are failing, the prospects of being wheelchair bound are short and the prospects of death are ominous.


aj

I am underwhelmed by the response from the street and the response here and on biotech values. This development appears to be a nonevent. You have to go over to yahoo to get ANY comment, and those jokers have buried their opinions under three pages of political crap that just drives the people who want to talk JAV away.

C'mon folks, any opinions about this? It would appear that a distribution channel as large as Baxter is a big positive and can allow wide distribution and keep a big share of the revenue.

aj

JAV: Overlooked news today with all the positives for all of these other great wins; is this the first step in getting what we longs want, a legitimate partner in distribution without giving the farm away? Read on:

http://biz.yahoo.com/bw/080731/20080731005114.html?.v=1

Javelin Pharmaceuticals and Baxter Healthcare Corporation Expand Commercial Supply Relationship for Anticipated Dyloject(TM) Global Growth
Thursday July 31, 8:00 am ET
New Supply Agreement Covers Expansion of European Dyloject Production with Premier Global Hospital Products Manufacturer


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Javelin Pharmaceuticals, Inc. (AMEX: JAV - News), a leading developer of novel products for pain management, today announced an agreement to expand its commercial supply relationship with Baxter Healthcare Corporation. The new supply agreement relates to Dyloject™, Javelin’s proprietary injectable diclofenac product currently marketed in the United Kingdom and in the second of two pivotal trials in the United States, for acute post-operative pain. The expanded relationship provides additional manufacturing capacity for Dyloject, principally for distribution in the European Union, and builds on the existing manufacturing agreement executed between Javelin and Baxter for the United States.
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"We are pleased to strengthen our relationship with Baxter. This expanded commercial supply agreement will provide increased capacity for Dyloject in Europe as we grow sales of the product in the U.K. and prepare for the anticipated launch of the product in multiple European countries in the near future.” said Martin Driscoll, Javelin's Chief Executive Officer.

“I am pleased we have completed this multi-year expansion of our Dyloject supply agreement with Baxter, which has the potential to significantly improve Dyloject’s gross margins, as the product’s sales volume increases in the UK and additional approvals are gained across Europe,” stated John Taylor, Vice President of Business Development for Javelin. “Solidifying our supply chain for Dyloject should improve the Company's position in our on-going partnership discussions.”

Dimebon and Medivation (MDVN): A competitor indeed. Dimebon may be a "nonselective" antihistamine, but that nonselectivity includes NMDA and CA channel modulation as well as apparent beta-amyloid blocking effects, it would blow aricept out of the water, if medivation plays it's cards right.

Recall my recent post on CA modulation:

http://www.sciencedaily.com/releases/2008/06/080625122954.htm

Instead of working from scratch to find a CALHM-1 modulator, Medivation may already have one ready for a P3.

That said, a swing of 6 ADAS points may be stat sig, but means little in the real world and is only 2 points more than the ADAS differences for Aricept if memory serves.

Back to the top of my focus list.

aj

SYMD and CAMH:

Psych7, you said, "I believe a buyout of some form will
happen or a R/S. Its frustrating when a startup company
really has the technology that works but the inability
to get complete FDA approval provides a not so pretty
picture for shareholders."

Hey, I can tell you that even when a co. HAS approval (CAMH has medicare reimbursement for MTWA testing that would save the govt $100's millions of dollars) it doesn't always work in the market.

Thanks for your reply. I'll continue to watch with interest.

aj

SYMD:

Psych7, I have had this on my watch list for some time. How closely do you follow them? Approval for REPEL-CV for pediatric patients is all well and good, but the FDA passed on letting them use it for adults (there have been no clinical trials here and I don't know the science about the problems with adult post cardiac surgical adhesions; others can feel free to educate us about this problem here.) An indication for REPEL-CV or getting it on a formulary as REPEL-(add your organ here) would do wonders for this co. but I see no movement towards this by the co.

Do you know what SYMD has done to convince either the FDA or practicing cardiac surgeons that an adult trial could be useful? I find nothing on their website.

regards
aj

"The emulsions, which are so small they are measured in nanometers—or 1/100 of a meter"

Of course the typo here is significant but obvious. A nanometer is one billionth of a meter.

aj

OT: Driving with AD.

That just about sums up about 1/2 of my referrals. In AR, if one has a significant concern, you can file a report with the state police and compel the individual to reassert their driving competence with an on-the-road test, but this is rarely done.

Driving is like language for many people, well overlearned and routinized cognitive behavior to the point of automatic processing. Executive function never enters into the picture of 90% of ALL drivers that I see.

I have heard many a story from small town AR families who state that their old loved one should not be driving but since the whole town knows it and knows the car, they just get out of the way when the suspect drives around town.

aj

Re: JAV

Bladerunner, I can't imagine mgmt trying to go it alone, particularly since they're on record about looking for partners and stating publicly that there has been an increase` in unsolicited interest from outside partners. Going it alone would mean they've failed miserably in getting a partner and would lose what limited credibility they currently have.

Biopete's post notwithstanding, I think that we will continue to bounce at this price range as mgmt buys at $2.41 in the recent private placement appears to have established the bottom. I agree with biopete that sales will come in light of the $220K estimate, but not by much. P3 data will see a boost in interest. I still believe that Dyloject will ultimately replace Toradol in most hospital practices and be a $200-300 million drug in a couple of years. PMI-150 will also find that type of market share for breakthrough pain, both in post-op and cancer settings.

Downside here is minimal, I'd be buying if I had some spare cash.

aj

Re: JAV

"What happened between then and now to drive the stock price down (besides the overall bear market in micro-cap biotech)?"

Bladerunner, imo, the co. has been caught in a downdraft that includes the bear microcap biotech market, with the lack of progress in meeting its own stated goals keeping the sentiment bearish for investors who have specific interest in the long-term prospects.

Dyloject approval in Great Britain was modestly delayed, first quarter revenue for GB dyloject was only in the $50K range, a shortfall even in the modest expectations. We're still waiting on approval in Germany. PMI-150 P3 trial has started, but again, there was some modest delay in the trial initiation. The co. added skilled mgmt with Driscoll and Kiernen (both well established players in pharma), and a private placement was done to provide enough cash to keep us independent through the PMI-150 trial (but with the attendant dilution). Mgmt has been clear they are looking for a partner, but that deal has yet to materialize. The sentiment that I've read from other posters on other boards is that mgmt has yet to find a partner that is interested in a deal good for JAV.

Too little is known right now about whether the co. is building out their sales force in GB and preparing for the same in Germany. They have set a high bar for Dyloject sales in Europe (something like $120 million by 2010 if memory serves) and this may also become a disappointment.

That said, Dyloject is still poised to become a new standard for post-op pain treatment and PMI-150 is a very strong candidate for post-op and breakfrough pain that is non-opiate.
I'm trying to remain patient, but the co. is trying all of our patience!

Short interest has reached almost 10%, several posters elsewhere think that this is hedging of long positions, but I'm hoping for a short squeeze. All the longs deserve a good runup and recovery. If they announce a good partnership deal, we should get to $10 range.

FWIW anyway,

aj

OT: ID and the weather

"Funny that there isn't an ID theory of meteorology."

The funny thing (for me at least) was that the ID debate was raging right at the time of Katrina, and one of our sharp political cartooninsts in AR drew a picture of the satellite image of the hurricane approaching the gulf coast with a caption "Intelligent Design?"

Parsimonious comment on the debate for many of us.

aj

Re: Lundbeck

"The company's chief financial officer, Anders Gotzsche, said Lundbeck would have 4 billion Danish crowns ($847 million) of cash in hand by the end of the year, giving it considerable firepower for doing deals.

Anybody have this guy's number? I've got a WHOLE bunch of JAV shares I could sell him and am willing to bet that the $14/share that their $847 million would bring to JAV owners for the rest of the outstanding shares would bring EVERY JAV owner to the table.

Lundbeck gets one approved drug, one destined for approval, and one likely to gain approval. Thats a deal worth doing.

aj

A total of 50K shares bought by insiders Can we reasonably expect that the end-of-day runup is anything more than a couple of retail investors trying to "read" their buys as a sign of things to come?

1 million shares is good volume, but for a $2 stock, the amount of shares traded is still pocket change for most wall street types.

On the other hand, if there was some leak that went along with the insiders' buys, we might finally be out of the cellar (lets hope so..I'm sick of the view from 10 feet under water!)

aj