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Rubitican--named after SUPG's former CEO Rubinstein.
And let's not forget about rfj1862utximab, a potent aphrodisiac.
>Did anyone notice that Bush wants to cut the NIH’s budget on an inflation-adjusted basis?<
I did. And the lying liar is claiming that he's increasing the funding for the NIH.
I won't get political here although it is very tempting.
>By 2011 the CABG market is 425,000 per year<
No it won't be 425K/year. A total of 427,000 procedures were performed in the US in 2004 (down from 467,000 in 2003 and 553,000 in 1998), and this number is likely to drop sharply as more and more patients with complicated anatomy undergo PCI.
Bison,
My portfolio goes through stages of building and winnowing. Right now I'm in the building stage. Essentially, I buy a basket of stocks I really like, reward the winners (in terms of data and price performance) with more cash and pare the losers, usually on a monthly basis. I end up with between 2 and 6 stocks in my biotech portfolio.
Right now, I'm sitting on RPRX, CRXX, AIS, JAV, SPPI, and NVD. RPRX is my largest position, CRXX, AIS, JAV are equivalent, and I own smaller amounts of NVD and SPPI. The remainder in cash. And of course this is supposed to be only 40% of my portfolio (although I'm currently suffering biotech bloat and have to rebalance), the rest being in "safe" stuff in a different account that I look at quarterly.
Anyway, the long explanation is because it's difficult to give an exact percentage since it changes monthly. I also usually keep some cash in my account to dole out the rewards.
The only reason I don't own more NVD is that I don't trust management. They did a really bad financing with warrant coverage.
JAV: My average purchase price is in the mid-4's, and it's not too much above that right now. So yes, I believe it is still a reasonable purchase. I try not to make predictions (although I succumb to temptation every once in a while) but I believe JAV remains significantly undervalued. I'm in the process of preparing an RMF for JAV.
As a warning, I'm wrong all the time...the reward/punishment system outlined above seems to keep me profitable, though.
And in case you're wondering why I have so many more stocks than I did a few weeks ago...my clients finally decided to pay me
I hate AMEX
or E-Trade, don't know which.
I had an order in above bid all day that never showed up and was never filled. Eg, the bid was 5.01, the ask was 5.03, my bid was 5.02. Orders at 5.01 were being filled.
I realize this is off-topic, but anyone know why?
>short answer quiz .mcu buy or sell?<
Sell. The evidence for MC-1 efficacy isn't remotely strong enough to warrant anything more than a trivial investment.
Plus MCU is headed for a disaster trying to sell tirofiban; getting uptake for this agent will require real expertise and substantial marketing spend. And as far as I can tell MCU has neither the expertise nor enough cash to do the job properly.
In short, let other investors suffer through this. If MC-1 is effective, there will be plenty of time to buy.
Anyone want to argue specifics, go ahead.
> Lupus Drugs Show Promise for First Time in 50 Years <
Don't forget IMMU
Clinical / Regulatory / Litigation Calendar
[Please keep entries up to date! See updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: RPRX
ACHN – See GILD
ADLR – Approvable letter for Entereg issued 11/6/06 requesting safety data due in 2Q07.
AGIX – ARISE data at ACC March 24-27, 2007.
AMGN – Vectibix PACCE trial in 1st-line CRC (Avastin+FOLFOX+/-Vectibix) interim PFS based on 25% of events: 2Q07 (probably ASCO). (PACCE showed no benefit vs control in RR.) Vectibix final OS from ‘408’ study: any day (low chance of hitting endpoint).
AMLN – Phase-3 LAR results: 2H07; Byetta monotherapy results: 2H07.
ANDS – ANA975 for HCV placed on hold 6/26/06 due to preclinical safety issue; human trials expected to resume in 2H07 following additional animal tox.
ANDS – ANA380 in HBV: phase-2 to begin in 2Q07.
ANOR / AOM.TO – pivotal AMD3100 results any day.
ASPM – Interim data from BRITE trial in depression: scientific conference in 2Q07.
BMY – Plavix trial begins 1/22/07.
BMY – Erbitux: see IMCL.
BOMSF -reporting pivotal MBP8298 results 2 years roughly
CEPH – Nuvigil for EDS approvable letter received 4/30/06; on 12/7/06, FDA said it was still studying one case of suspected SJS in Sparlon data set.
CLSC - Two phase 3 Trials 1600-2000 patients to complete in calendar Q4 with public " top line data" on results anticipated for calendar Q1 07. This is a 10 week trial.
COLY – Phase-3 PF-3512676 in NSCLC (by PFE): late 2007 or 2008 (2 trials).
CONR: see JNJ.
COR – Go/no-go decision on CX-717: April/May 2007 following FDA review of the tox report now in preparation by COR’s CRO. (FDA clinical hold was partially lifted 10/9/06.)
CORT – Phase-3 trials of Corlux for psychotic major depression: ‘06’ trial results any day. (The first phase-3 trial called ’07’ reported failed results on 8/25/06; the 2nd phase-3 trial called ‘09’ reported failed results 9/29/06).
CRME - IV RSD1235 NDA refiled, FDA decision likely 4th qtr/07.
CYT.TO - Initiated pivotal A-fib trial Oct/06. Results timing, will update when company provides timeline.
CYPB – Phase-3 Milnacipran in fibromyalgia, second phase-3 results: mid 2007 (#msg-9132392).
DDSS (formerly LBPFF) – Response to and appeal of Tramadol approvable letter submitted 12/20/06.
DNA – Avastin in breast cancer: FDA requested additional data confirmation on 9/11/06; resubmission by DNA pending.
DNDN – Provenge BLA: advisory panel expected in March 2007; PDUFA date mid-May 2007.
DNDN – 9902b study: enrollment complete in 2007; interim data look 1H08.
FRX - Milnacipran in fibromyalgia: see CYPB.
GILD – Viread for HBV: phase-3 results 4Q07, NDA (if successful) 1H08.
GILD – GS9132 for HCV (with ACHN): phase-1/2 results 1Q07.
GILD – GS9190 for HCV: start phase-1 any day.
GPCB – Satraplatin SPARC trial: final overall survival: fall 2007. (The trial hit the primary PFS endpoint on 9/24/06; interim OS look announced on 6/8/06 failed to meet threshold for unblinding.)
GTCB – ATryn EU launch for HD: June, 2007.
GTCB – ATryn DIC program in EU: start of ph-2 (by Leo Pharma) any day.
GTCB – ATryn ph-3 for HD in U.S.: complete enrollment 1H07, submit BLA 2H07.
GTCB – Merrimack MM-093 phase-2b in RA, phase-2 in psoriasis to be presented at EULAR in June 2007.
GTOP – Final MyVax results Dec 07.
IDIX – Tyzeka for HBV action date in EU, China: early 2007 (approved by FDA 10/25/06).
IDIX – Tyzeka phase-3 in decompensated liver disease: enrollment complete in 1Q07 (75% complete as of 9/27/06).
IDIX – NM283+ribavirin drug-interaction study: 36-day efficacy data 1Q07; 12-week safety data late 1Q07 or 2Q07.
IMCL – (See #msg-9218093 for selected Erbitux trials):
1) CRSYTAL trial in first-line CRC hit its PFS endpoint (announced 1/10/07); full data release at ASCO in June, 2007.
2) Erbitux in NSCLC. OS in 1st-line FLEX study: 2H07.
3) Erbitux in pancreatic cancer, SWOG trial: 1Q07.
ISA.TO - Begin European/Cdn pivotal psoriasis trials this qtr, begin U.S. pivotal psoriasis 07, complete enrollment in renal Phase IIb & also interim renal data 1st qtr 07.
ITMN – Ph-1 data for ITMN-191: 1H07
JNJ: CoStar (CONR) data from U.S. pivotal trial: March 2007 at ACC
LBPFF – see DDSS
Merrimack: see GTCB
MS.TO - Complete enrollment in pivotal Secondary Progressive MS trial this year, possible interim results 2007, trial results in 2008.
Novocell – see SRDX
NRMX, NRM.TO – North American Alzhemed trial complete Jan 07, results to follow. European Alzhemed trial complete 1H08 (?). Kiacta (Fibrillex) received an approvable letter on 8/11/06.
NRPH – NRP104 in pediatric ADHD: approvable letter 10/6/06; full approval pending DEA scheduling.
NVS – Galvus PDUFA date late Feb 2007.
NVS – Tekturna PDUFA date mid Mar 2007.
NVS – Tifacogin: enrollment complete 1H07 (#msg-15157973).
PHRM – See GPCB.
PPHM - Bavituximab phase 1B HCV; four doses monotherapy over 14 days, followed for 12 weeks post-therapy, in previous non-responders/relapsers. Patient enrollment completed Oct 24, trial results due 1Q 07.
PPHM - solid tumor 8-week chemo & Bavituximab combination therapy, info due 1Q '07.
RPRX
Proellex
*Uterine Fibroids Phase 2 (U.S.) Full Phase 2 data (mid-2007)
*One year extension data (4Q2007)
*Initiate pivotal trials (YE2007)
*Endometriosis Phase 1/2 (Europe) Full Phase 1/2 data (3Q2007)
*Initiate U.S. Phase 2 (mid-2007)
Androxal
*Male Secondary Hypogonadism Non-pivotal Phase 3 (U.S.) Full non-pivotal Phase 3 data (3Q2007)
*Initiate first pivotal Phase 3 (around YE2007)
SGP – Ph-2 data for SCH 503034 in HCV: 2H07
SNY – Acomplia PDUFA date: 4/26/07.
SNY – Plavix litigation: trial begins 1/22/07.
Speedel – See NVS.
SPPI – See GPCB.
SRDX - Novocell phase-1/2 trial in type-1 diabetes: late summer 2007 (enrollment complete 8/30/06).
TH.TO -Begin confirmatory TH9507 HIV Associated Lipodystropy trial 1st qtr/07
VRTX – PROVE-1/PROVE-2/PROVE-3 timetable: see #msg-12267294
YMI – AeroLEF final results any day (interim results announced on 9/27/06 failed to meet threshold).
--
Procedure For Updating Clinical-Trials List
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old list. You can find a pointer to this list in the iBox at the top of the main message-board screen.
2. Make your additions or modifications, inserting any new items in alphabetical order.
3. Post the updated text in a new message in reply to the message with the old list.
RPRX RMF
Any regular poster may update this file; feel free to e-mail me for the source file with the formatting. Permission granted to cut, paste, slice, dice, or repost elsewhere.
Warning: opinions ahead. Take it for what it’s worth.
Edits:
*Added information on financing
*Amended information on timelines
I would appreciate any additional comments via private message or e-mail…no need to clutter the board.
Company
RPRX is a biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive system disorders. The company’s name was changed to Repros Therapeutics Inc from Zonagen, Inc, “in order to more appropriately reflect [a] focus on the reproductive and hormonal health technology market.”
RPRX management has been upfront about their desire to sell the company or individual programs. Provided continued positive results in clinical trials, this company will be sold eventually.
From a brokerage report:
Proellex and Androxal represent exactly what we look for as investable assets in biotechnology: they address very large markets, are in drug classes that have demonstrated positive, validated risk-benefit profiles, and are wholly-owned by the company. Additionally, we believe that the areas of male and female reproductive health are poised to be areas of significant growth, relative to other sectors in healthcare, which makes Repros a particularly attractive investment at this time.
Near-term catalysts
Proellex
Uterine Fibroids Phase 2 (U.S.) Full Phase 2 data (mid-2007)
One year extension data (4Q2007)
Initiate pivotal trials (YE2007)
Endometriosis Phase 1/2 (Europe) Full Phase 1/2 data (3Q2007)
Initiate U.S. Phase 2 (mid-2007)
Androxal
Male Secondary Hypogonadism Non-pivotal Phase 3 (U.S.) Full non-pivotal Phase 3 data (3Q2007)
Initiate first pivotal Phase 3 (around YE2007)
Unknown timing
*Sale/partner Androxal in Europe (estimate 2007)
Products
Proellex
Proellex is an orally administered, selective progesterone receptor modulator (SPRM) in development for the treatment of uterine fibroids and endometriosis. Proellex inhibits the progesterone receptor without inhibiting the production of estrogen activity, which is a marked improvement over the current standard of care for both diseases, Lupron (Lucrin). Long-term use of Lupron causes severe estrogen deficiency that may cause depression, mood swings, abnormal bleeding, and osteoporosis.
Because of its drawbacks, Lupron is indicated for <6 months of treatment. Because of the shortcomings of Lupron, Proellex only has to provide similar efficacy to supplant Lupron from the market. However, as noted below, initial data suggest that Proellex is far superior to Lupron.
Proellex market
*13.6 million women in US with uterine fibroids, approximately one-quarter of whom could benefit from treatment.
*5.5 million women in US with endometriosis, the majority of whom could benefit from treatment
*Sales for asoprisnil (former competitor, pulled from clinical trials) estimated at $600 M for uterine fibroids alone
Phase II/III uterine fibroids trial—design
*Enrolled 150 women with signs/symptoms of uterine fibroids
*Patients receive 0, 12.5, or 25 mg Proellex
*Three-month multicenter study with open-label extension
*Primary end point: bleeding
*Secondary end points: pain, quality of life, and fibroid size
*Safety: endometrial effects and bone loss
Phase II/III uterine fibroids trial—results and qualitative analysis
Perfect results.
1) For the primary end point of uterine bleeding, both the 25 mg and 12.5 mg doses showed incredible results. The P-values were, respectively, .00003 and .000005, which meets the pre-specified threshold for declaring the trial a statistical success with the interim results. I expected this result, but not such low P values.
2) For the secondary end point of QoL, both the 25 mg and 12.5 mg doses showed excellent results, with P values of .0046 and .0029, respectively. Given that QoL measures are often squishy, I did not expect this result. I expected a trend toward improved QoL.
3) Pain scores. Again much better than expected, particularly at the 25-mg dose (P=0.006).
4) Great safety results, which were the key to this trial. Seven placebo patients, six 12.5–mg patients, and three 25-mg patients had thickening. Most importantly, no hyperplasia with atypia was observed in any patient. This result is substantially better than expected.
5) No results for the secondary end point of fibroid size.
Phase II endometriosis trial—design
*Enrolled 40 women with endometriosis,
*Patients treated for 6 months with double-blind Proellex at dosages of 12.5, 25, and 50 mg
*Active-controlled with Lupron
*Primary end point: pain
*Secondary end point: bone loss
*Conducted in Eastern Europe. Note that treating physicians (N=22) were randomly allocated to open-label high (n=21) or moderate (n=1) vodka intake
Phase II endometriosis trial—results and qualitative analysis
Perfect results.
1) The 50-mg dose was statistically significantly better than Lucrin in terms of days of pain (P=0.02). Remarkable result, given that there were only 10 patients in each dosing group. Works out to about 4.5 days of pain for Proellex vs 29 days of pain for Lucrin.
2) During those 4.5 days of pain, the 50-mg dose of Proellex provided a statistically significant (P=0.02) improvement in pain severity compared with Lucrin.
3) Proellex provided excellent efficacy for pain-associated distress, with a P-value of 0.001 vs Lucrin for the 50-mg dose. Only one woman reported mild distress in the Proellex group.
4) Safety: as expected there were no significant changes in biomarkers of bone resorption in any of the Proellex groups. Although expected, this is a key result Lucrin causes bone loss, which limits its applicability as a chronic therapy.
5) Most importantly, no endometrial thickening at the 50-mg dose, no significant endometrial thickening at any Proellex dose and no endometrial hyperplasia with atypia at any dose.
Proellex commentary
In short, when taken the data are taken separately or together both trials were incredibly successful. The results of both studies far exceeded my expectations on every end point.
Proellex SWOT
Why do I feel like I'm at work?
Strengths:Outstanding efficacy in two markets with significant unmet need; FDA likely to be very supportive for both indications.
Weaknesses: Potential for endometrial hyperplasia remains the primary concern.
Opportunities: Proellex is probably generating significant interest from potential acquirers already; Applications beyond endometriosis and uterine fibroids
Threats: FDA requirements for phase III uterine fibroid trials (one or two trials?); potential competition (longer-term); RU-486 issues
Androxal
Androxal is a novel, orally-administered small molecule in clinical development for the treatment of testosterone deficiency in men. Unlike treatments that artificially replace testosterone in the body, Androxal restores testosterone by stimulating natural production of testosterone through the upregulation of the pituitary hormones (including FSH). The re-activation of the hypothalamic-pituitary axis results in normal, physiological levels of testosterone that replacement therapies aim for.
The production of FSH may have benefits for infertile men, an area in which few treatment alternatives are effective. Androxal’s unique mechanism of action also avoids many of the side effects associated with testosterone formulations, most notably, the testicular atrophy and/or infertility caused by supra-normal testosterone levels achieved with topical/transdermal and injectable testosterone products. Androxal is also not subject to partner risk and has no abuse potential because it does not produce supranormal testosterone levels.
Androxal market
Testosterone creams, gels, patches, and injections: ~$450 M worldwide, $150 M Europe only. Significant opportunity for market expansion.
Androxal Phase III—design
*Enrolled 200 men with testosterone levels <300 ng/dL
*Patients randomized to treatment with Androxal 12.5 mg, Androxal 25.0 mg, placebo, and open-label Androgel
*6-month treatment period with open-label extension
*Primary efficacy end points: testosterone levels, libido,
*Secondary end point: “distress”
Androxal Phase III—results
In this interim analysis, men treated with 12.5 mg of Androxal experienced an increase in mean testosterone of 210 ng/dl (P<0.0001) over baseline; those treated with 25 mg of Androxal experienced an increase of 241 ng/dl (P<0.0001) over baseline; and those treated with open-label Androgel, administered at any dose, experienced an increase of 167 ng/dl (P=0.0002) over baseline. As expected, men receiving placebo experienced no statistically significant change in mean testosterone.
Note that, according to the protocol, these data are sufficient to formally declare the trial a statistical success for the primary end point.
There was a dose-related trend toward improvement in distress, which is really all I expected at this point. No trend in libido, although Androxal and AndroGel performed similarly for this end point.
Androxal commentary
Data from Phase III study are very good but not perfect.
What these data suggest is that Androxal may be approvable ex-US: European regulatory authorities have indicated that restoration of testosterone levels to normal is an acceptable single end point. Market in Europe is ~$150 million; Global (ex-US) perhaps $300 million.
Eventual approval in the US remains open to question, but given that there are several testosterone-replacement therapies with serious drawbacks, the FDA may consider Androxal, in clinical context, as a safer alternative.
Three months may not be enough time to see statistically significant changes in the soft end points of libido and distress, so the US story here remains open.
According to the company, “With these encouraging results in hand, we will seek to identify a licensing partner for Androxal in Europe.” This statement suggests that dilution when (and now if) it comes will be substantially smaller than it might otherwise be.
Androxal is of secondary importance in RPRX's portfolio. In short, these results are nice but not critical. I would like to see Androxal leveraged to get the Proellex programs done with minimal dilution.
Androxal SWOT
Strengths: Outstanding efficacy for primary end point; significant safety advantages over existing therapies.
Weaknesses: Has not shown efficacy for libido, and only a trend toward efficacy for distress (note: similar results were seen with AndroGel)
Opportunities: Partnership ex-US may reduce/eliminate need for cash
Threats: FDA requirements for approval.
Competitors
Proellex
Uterine fibroids
Primarily surgical (hysterectomy, selective myomectomy). Both procedures have obvious implications for reproductive-age women.
Lupron has an indication for 3 months of treatment to shrink fibroids.
Endometriosis
GnRH analogs (Lucrin), progestins, oral contraceptive pills, androgens, and aromatase inhibitors. After a trial of an oral contraceptive, GnRH analogs are standard of care.
Lupron has obvious drawbacks, including need for injection, and of course all the problems that come with down-regulation of estrogen. GnRH analogs are indicated only for short-term use.
Danazol (synthetic androgen) can also be used but it has a bunch of nasty side effects, and there are also surgical procedures that can correct endometriosis. According to Dewophile, danazol is no longer used in the clinic.
Asoprisnil was in the pipeline, but was terminated because of an excess of procedures related to endometrial thickening. Notably TAP made a business decision to terminate this trial even though the DSMB disagreed, so some day this one might come back.
Physician perspective on competitors: http://tinyurl.com/ybnff3
Androxal
Primarily testosterone gels/creams (AndroGel, Testim), which have a bunch of very serious limitations, including testicular atrophy, partner risk, abuse potential, and an issue with worsening of secondary hypogonadism. There is also the option of administration of exogenous testosterone with all of its attendant problems.
In addition, Clomid could be used, but its cis isomer has estrogenic effects and an extremely long half-life. Note that Androxal is just the trans isomer, which does not have these effects.
In short, the limitations of current products for testosterone deficiency can be summed up as: do you want a hairy girlfriend and shrunken testicles, or would you prefer to schedule a fitting for a manssiere?
See the following link for physician perspective: http://tinyurl.com/ybnff3
Financial
Burn rate ~$3 million per quarter with 3 active clinical trials; ex-clinical trials burn rate ~$700,000 per quarter
Sold 2.61 M shares at $13.75 for total proceeds of roughly $36 M
Coverage and targets
ThinkEquity: $18
Punk Ziegel: $25
Rfj1862: $93.48 and a nice loft in Tribeca in a pet-friendly building with private outdoor space and an elevator. Thanks!
Potential acquirers
Note that the company is upfront about wanting to sell either the entire company or individual programs.
Analysis based on current portfolios, not pipeline gaps (in which case any number of big pharmaceutical companies may be interested). Also assumes sale of both programs to the same entity.
High probability
Bayer (markets testosterone replacements, estrogen replacements, contraceptives)
Medium probability
Barr Laboratories (markets contraceptives)
Organon (markets contraceptives)
Pfizer Inc (markets contraceptives and an erectile dysfunction product)
Links
Presentation: http://tinyurl.com/yznoyy
Insider activity: http://tinyurl.com/yeoe2d
Website: http://www.reprosrx.com
Why Proellex is different from mifepristone (RU-486): http://tinyurl.com/ychr56
Risks and rewards (pre-December results): http://tinyurl.com/yfs7vz
Predictions for December results: http://tinyurl.com/yh2bu7
Another pre-result take on RPRX (from a physician’s perspective): http://tinyurl.com/yce5qa
Now, to whom should I send the invoice?
NovoSeven
>I would take NovoSeven over FEIBA or any plasma-derived product.<
Totally agree. In fact, I don't remember which guideline says this, but one of the major guidelines states that "every effort should be made to provide recombinant product." Or something to that effect. The real risk is very small, but why take chances?
That aside, there are numerous reasons to choose NovoSeven over FEIBA. As a recombinant product, you can be absolutely sure you're injecting an appropriate amount of drug; also NovoSeven requires a hell of a lot less reconstitution time and much lower volumes are required to treat a bleed compared with FEIBA.
NovoSeven
The interesting thing about NovoSeven is that they fight it out on a patient-by-patient basis with FEIBA. Each patient is worth between $300,000 and $500,000 each year. At $1B in sales, that's what, 2000 to 3300 patients?
Anyone who says treating rare diseases isn't worthwhile should consider these numbers.
RPRX
Hopefully my last post on RPRX until the next big event.
I am pleased with the pricing, particularly considering RPRX closed on Monday at 13.08. Looks like they split the difference between the opening and closing price on Tuesday.
I'd be willing to bet this is the last time RPRX raises cash before it is acquired. Even if it is not acquired within the next 12 months (which I believe it will be), they still have the Androxal asset to sell in Europe, which will give them more than enough cash to complete the Proellex program all the way through submission.
I was rather hoping for a bigger dip before I devoted my last 25% to RPRX...but the market seems to be contrary, as usual.
I will update the RPRX RMF, and then that's it from me until the next big event.
YMI
>Highly unlikely, IMO. If you believe this is likely...<
It doesn't matter what I believe. What matters is that I think the market will assign a high enough value to YMI--based on the prospects for nimo--that I can make a decent profit over 3 to 6 months. That's all I care about.
And no, I'm not acting as David's mouthpiece. I was in YMI well before BTM, and out long before most others.
Anyway, I'm not going to bet the house on it. Call me a nitwit.
Serious. I don't think YMI is a 'quasi-legit scam company.'
Nimotuzumab has considerable promise, particularly given the recent demonstration that EGFRs are effective upfront for mCRC. Provided equivalent efficacy, nimo has the potential to completely supplant cetuximab because of the side-effect profile.
As always, I only care where YMI is going to be 6 mo to 1 y down the road. If I can get this at or near cash, then I'm in.
YMI
>FYI re YMI: Don't<
Thanks for the advice, but I am quite familiar with this story.
I have been waiting for the tesmilifene trial to fail so that I can purchase for nimo.
YMI
Just looking through my old posts on YMI and found this one.
>Positive YMI mention!
2/2/2006 5:18:13 PM Business Week's "Inside Wall Street" column mentions DMC, RNVS, YMI positively.<
Haven't found the article yet. Don't like being in the same column as RNVS.
J
YMI
Time to buy....
I've never placed an AH trade for a stock trading on the American Exchange. Can someone tell me why my bid doesn't show up?
No, not hacked. The "Butthead" reminds me that I don't know everything...the "Smack my ass and call me Sue...." I probably shouldn't explain. But it is funny when I call E-Trade and they ask me for the account name.
E-Trade Margin Requirements...
Go to trading and portfolios main screen, second paragraph below order entry ticket. Click on “See complete list.”
For your amusement:
This is the e-mail I get from E-Trade when I do a direct transfer:
Dear Butthead!
Your request (Reference Number: XXXXX) to transfer $X from Chase-XXXX to Smack my ass, call me Sue-XXXX was successfully completed on 01/30/2007 at 12:58:05 ET.
Margin
E-Trade has a list of all stocks with special margin requirements. RPRX is indeed 50%. Nice experimental work on JonathanRobinson's part, though.
Don't have time to give you the exact clicks to get to the list, but trust me it's there.
OT but interesting: Potential new requirements for "accredited investors"
Via John Maudlin's e-mail newsletter (which is interesting, worth subscribing to)
The Securities and Exchange Commission (SEC) has posted a new proposed rule that would raise the minimum net-worth requirement needed to invest in private funds from $1,000,000 total net worth to $2.5 million liquid net worth. This is a major change, and it means that some 7% of American households will no longer be able to invest in private offerings. In my opinion, it is likely to become law in the not too distant future unless there is significant public comment. This week we look at the proposed rule and some of its consequences, as well as a very interesting proposal by SEC commissioner Roel Campos.
Let's start with some background. The current definition of an accredited investor was adopted in 1982 and was set at $1,000,000 total net worth, including your home and other assets. At the time, according to the SEC, some 1.87% of all US households were qualified to invest in hedge funds and other private equity offerings. Due to inflation and the growth in all sorts of assets, including homes, today about 8.5% of US households are eligible. The original rule was proposed to keep supposedly unsophisticated investors from getting involved in investments like hedge funds, which were considered riskier than mutual funds.
If the original amount were adjusted for inflation, the net-worth requirement today would be $1.9 million. The SEC proposes to raise that limit to $2.5 million in investment assets, so your home or primary business real estate would not be included in the $2.5 million. This would reduce the number of investors eligible to invest in hedge funds by about 88%, or to just 1.29% of American households. Since they are proposing that the amount be adjusted for inflation every five years starting April 1, 2012, that would suggest to me they are considering adopting the proposal as early as April of this year, although there is no way to be certain, as comments could alter the proposals.
The SEC is asking for comments as to whether the proposed changes in the net-worth requirement are too much or too little, and more interesting, whether net worth alone should be considered. I will put a link to the proposed rule changes and explain how you can make comments if you should desire to do so, later in this column. But first, let's look at some of the practical and philosophical implications of the proposed rule, and why you should care about this no matter what your net worth is.
First, the SEC is being consistent with the mandate they have from Congress. Congress long ago established rules on private offerings, and among them is the requirement that private offerings such as hedge funds are only offered to sophisticated investors who are capable of understanding the risks and have the financial capacity to withstand potentially significant losses.
Since there is no test you can take to prove sophistication, a net-worth requirement was established under the presumption that someone with sufficient capital was either sophisticated or would have advisors who were capable of doing the proper due diligence on any such offering.
Given that $1,000,000 isn't what it used to be 25 years ago, if you agree that private offerings of unregistered funds should be subject to some level of investor sophistication, then it makes a certain level of sense to raise the bar.
It may surprise readers to know that on a practical level I agree with the thinking that it requires a certain level of sophistication to invest in unregistered private offerings. This is the field I work in, and I can confirm that hedge funds are not for unsophisticated investors. They can be quite complex and involve different sets of risks than other types of investments. There are many reasons for the following risk statement that accompanies nearly all hedge fund offerings:
"When considering alternative investments, including hedge funds, you should consider various risks including the fact that some products: often engage in leveraging and other speculative investment practices that may increase the risk of investment loss, can be illiquid, are not required to provide periodic pricing or valuation information to investors, may involve complex tax structures and delays in distributing important tax information, are not subject to the same regulatory requirements as mutual funds, often charge high fees, and in many cases the underlying investments are not transparent and are known only to the investment manager."
I also think it is philosophically wrong to limit the choices of investors based simply upon assets. The rich have advantage enough without limiting the choices of those with less assets. But before we get into that, let's look at some practical implications.
First, the rules are such that private offerings are limited to 99 investors with a net worth of $1,000,000 or more. If a fund agrees to only take investors with a net worth of $5,000,000, then they can have up to 499 investors.
But let's deal with a fund that can take investors with $1,000,000 net worth. Let's assume an investor has $2,000,000. Even if they were willing to invest $250,000, that would be a significant percentage of their assets in one fund. If an investor was worth $1,000,000 including his house, that would be a prohibitively high proportion of his net worth.
If a fund accepted 99 investors for just $250,000 apiece, that would mean the fund would only have $25,000,000, which quite frankly would be a small fund. And while some start-up funds may take smaller amounts, in the long run if the fund becomes successful, the minimum investment they require begins to increase beyond the practical ability (in terms of reasonable diversification) of investors with less than $2.5 million, in any event.
There are some exceptions. As an example, commodity funds, because they are regulated by the CFTC and NFA, can have an unlimited number of accredited investors. There are some hedge funds that will take a limited number of smaller investors, but frankly not many. So, for all practical purposes, raising the limit does not have that much of an affect on the opportunities for most investors, as there are sadly not enough opportunities available under the current rules.
(As an aside, under the proposed rules, it is not clear whether the SEC intends for this rule to apply to commodity funds. While commodity funds are offered as private funds, there are differences in the rules they follow. This is a topic that should be specifically addressed in the final rules.)
I should note that in England there are no real net-worth requirements for investing in hedge funds. Investment advisors are required to determine the sophistication and suitability of potential investors regardless of net worth. And Europe is slowly moving to open up hedge funds to investors within a regulatory framework.
Also, the SEC proposal specifically exempts private equity funds, as they provide a great deal of the funding for new business in the US. I would also note that, in my opinion, equity funds are in general more volatile and harder to understand than most hedge funds. But the commission is right that private equity funds are important for American business.
RPRX
I think there has naturally been a lot of interest in RPRX given that they've had 3 trials report with great results, the upcoming financing, and all of the other stuff that's going on. I'd expect the conversation to taper off after next week, at least until the next big event.
I don't see any need for additional discussion on RPRX right now...everything that can be said about the data has been said.
I also don't see any need for a separate RPRX board, or a separate board for other biotechs, for that matter. If I'm not interested in something, I'll skip over the post.
And I don't mind an occasional well-informed trading post, or TA information as part of the larger picture, or people announcing that they've bought or sold a particular stock. It's all relative. I just don't want to see a lot of one-sentence trading spam--you can get that on the other 99% of boards on I-Hub.
I won't engage in discussions outside of the Biotech Values board. Sorry, I don't have time to monitor >1 board.
OT autoclaves
No, autoclaves do not use microwaves. They're essentially giant high-pressure steam cookers. And yes, you can sterilize all sorts of things in them, metal, plastic, wood, rocks, little sister. They're also good for making lunch.
>Also way OT. You can use your microwave to create your own little Fourth of July display , using just a Brillo Pad.<
Also way off topic. You can use a pickle as a lightbulb. Just keep pets away. I wonder if the pickle is sterile after being used as a lightbulb?
http://www.darylscience.com/Demos/PickleLight.html
At some point Dew is going to delete this thread
OT: Sponges
>I've been only nuking them for 25 seconds. The sponge is steaming and near boiling temps (hot!) which I consider sufficient to kill most household bacteria. I can't imagine going for longer than 1 minute, let along 10 min. Overkill imho.<
Not even close. Think of an autoclave: 20 minutes of high-pressure steam is necessary to get things truly sterile.
You could always pop them in a pressure cooker.
As someone who has done considerable amount of work in microbiology, I think that American's obsession with germs is funny. There's this hilarious commercial on Bloomberg for some kind of disinfecting wipe: the tag line is something like "life doesn't have to stop to disinfect." The commercial plays over the sounds of a laughing child. I can just imagine the mother, disinfecting wipe in one hand, child in the crook of her arm, ensuring that everything is disinfected for baby before she puts him down.
In short, wash your hands and dishes, and try not to pick your nose unless you've washed first. That's all you need. And please wash post-pick as well. That's just common politeness.
RPRX
>rfj-- are you going to the event??<
No. Although I own a good chunk of RPRX, I don't own enough to justify going to the show. Aside from that, what could they possibly say that we don't know already? RPRX is a simple story and management is communicative if you call them.
And unlike Dr Bill, who seems to think that $80 is a reasonable target for next year(!) I think it is reasonable--in terms of market cap--for this to be a $250-$350 M stock this year. However, in terms of multiples of current PPS, even this is an ambitious target.
Myocardial markers
From an investment standpoint, this isn't something I care about much, but as a public service I thought I'd post a summary of markers for everyone's reference. Since I have it on hand.
JAV NVD
Ha ha. I don't think I'm going to be taking a 10% position in a $200 M company this decade.
JAV, NVD, RPRX
>I am curious now about your thoughts on JAV and NVD! :) Are you willing to outline these companies at all on the Biotech Value forum?<
Although I don't have time for discussing these in detail:
JAV
1) Three products in late-stage clinical development that
address major existing medical needs in the management of pain, 2) Products that are differentiating, new formulations of well-known chemical entities with very well established efficacy and safety profiles
3) Positive Phase II safety and efficacy data already
available for all three products currently in development
4) Pivotal trials in acute pain indications that are easy to test, lowering development risk
5) Insiders buying like crazy
The key product is Dyloject, an injectable formulation of diclofenac (an NSAID). It's awaiting MAA approval. http://www.javelinpharmaceuticals.com/_documents/JVPHMAA102405.pdf
NVD
Is another reformulation company. This one reformulates existing products as oral sprays. Among other drugs, Zensana (oral spray ondansteron) should be approved this year, NitroMist is already on the market, and perhaps most exciting is an oral spray formulation of Ambion. They have a bunch of other drugs in the pipeline (for migraine, neurologic spasticity, and Parkinson's disease, and development is quick and cheap because they use the 505(b)(2) regulatory pathway.
Caveat for NVD: They just did a horrible financing with stock + warrants that was unnecessary in my view.
I've been in and out of XNPT, which is yet another reformation company; they have a gabapentin analog they're testing for restless leg syndrome and neuropathic pain, and perhaps more importantly a baclofen analog for GERD and spasticity. I've done well (twice) with this company, although I'm not currently in because I view it as more than fully valued. Worth watching if it falls below $20 or if the underlying story changes. There's a somewhat out-of-date RMF somewhere on Biotech Values if you want to know more.
See a common theme here?
Hope that was coherent...I've been working my ass off and not getting any sleep because they're filming a freakin' movie outside my bedroom window that involves--literally--400 or 500 extras, ambulances, police, helicopters, crap flying off the Brooklyn Bridge, and Will Smith. I think it is called I Am Legend.
RPRX
Spartex,
My estimation of when the trial would report was based on a misinterpretation of the data. It was based on full enrollment as of September 1, which of course we know is not the case (nor did RPRX ever say it was). They were only partly enrolled as of September 1, so say the last patient enrolled was Nov 1, which would put completion at May 1 and report end of May/beginning of June. This timeframe is consistent with what I've seen estimated from more reliable sources than myself.
I've been meaning to update that information. I'll update the RPRX RMF when we get a price for the offering.
Like Dewophile, I'm staying in. I don't know about you but I can't find another $125 M company with a late-stage blockbuster in its pipeline that has close to zero efficacy risk. If anyone has any suggestions I'm listening, because I'm sitting on a bunch of cash in my biotech portfolio in addition to my positions in RPRX, JAV, and NVD.
I was on the 50% before results/25% after results/25% after financing plan (in dollar terms), and I'm sticking with it, although I did do a little trading after the results.
RPRX
>I was waiting for this announcement to buy more<
Me too. Unfortunately, I assume a lot of people were waiting for this announcement to buy more. Which, of course, means that we might not get much of a bargain. Volume is very low; the announcement doesn't seem to be inciting the usual panic among the lemmings.
RPRX
>Theoretically the nbix compound could change the entire market for endometriosis/fibroid therapy<
We do not have enough data to make any sort of valid comparisons; the studies used different measures. Please also note that they are not testing it in uterine fibroids.
NBIX has also demonstrated themselves utterly incapable of getting a drug approved, so no matter what happens with their clinical trial program, it's going to be a long, long wait for it to get to market.
And regardless of what happens with NBIX's compound, RPRX is a $130 million company. Relax.
DNDN
>But I cannot shake the impression that the depression of the share price is facilitated by activities in the market that ought to be prosecuted.<
What I do not understand is what motivates people to keep their money in DNDN if they feel that it is being manipulated.... cut your losses and move on. If you do even a little DD, you'll find that there are plenty of companies that represent better value and have less risk.
Sometimes I think people just enjoy bitching about their stocks.
>This trial was set in large urban areas where patients arrive at hospitals/trauma centers quickly.<
Just a question: have significant differences in time to the emergency room been demonstrated among urban, suburban, and rural areas? I for one wouldn't want to have a need for an ambulance in Times Square at 5 pm.
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
JANUARY
ASCO Gastrointestinal Cancers Symposium
Orlando, FL
Jan 19-21
www.asco.org
American Academy of Cosmetic Surgery
Phoenix, AZ
Jan 25-28
www.cosmeticsurgery.org
Annual Clinical Cancer Update
Lake Tahoe, CA
Jan 26-28
www.cme.ucsf.edu
International Symposium on Endovascular Therapy (ISET)
Hollywood, FL
Jan 28-Feb 1
www.iset.org
Society of Thoracic Surgeons
San Diego, CA
Jan 29-Jan 31
www.sts.org
FEBRUARY
American Academy of Dermatology (AAD)
Washington, DC
Feb 2-6
www.aad.org
American Academy of Orthopedic Surgeons
San Diego, CA
Feb 14-17
www.aaos.org
Society of Critical Care Medicine
Orlando, FL
Feb 17-21
www.sccm.org
American College of Preventive Med (ACPM)
Miami, FL
Feb 21-25
www.acpm.org
ASCO Prostate Cancer Symposium
Orlando, FL
Feb 22-24
www.asco.org
American Academy of Allergy Asthma and Immunology (AAAAI)
San Diego, CA
Feb 23-27
www.aaaai.org
MARCH
Generic Pharmaceutical Association (GPhA)
Phoenix, AZ
Mar 1-3
www.gphaonline.org
Society of Interventional Radiology
Seattle, WA
Mar 1-6
www.scvir.org
Society of Gynecologic Oncologists
San Diego, CA
Mar 3-7
www.sgo.org
American Academy of Emergency Medicine (AAEM)
Las Vegas, NV
Mar 12-14
www.aaem.org
International Conference Primary Therapy of Early Breast Cancer
St Gallen, Switzerland
Mar 14-Mar
www.oncoconferences.ch
American Society for Clinical Pharmacology & Therapeutics
Anaheim, CA
Mar 21-24
www.ascpt.org
American College of Cardiology (ACC)
New Orleans, LA
Mar 24-27
www.acc.org
16th European Congress on Clinical Microbiology and Infectious Diseases
Munich, Germany
Mar 31-Apr
www.akm.ch/eccmid2006
APRIL
National Kidney Foundation
Orlando, FL
Apr 10-14
www.kidney.org
American Association of Orthopaedic Medicine
Las Vegas, NV
Apr 11-14
www.aaomed.org
European Association for the Study of the Liver
Barcelona, Spain
Apr 11-15
American Association of Clinical Endocrinologists
Seattle, WA
Apr 11-15
www.aace.com
American Association for Cancer Research
Los Angeles, CA
Apr 14-18
www.aacr.org
Federation of American Societies Experimental Biology - FASEB
Washington, DC
Apr 28-May 1
www.faseb.org
American Academy of Neurology (AAN)
Boston, MA
Apr 28-May 5
www.aan.com
MAY
American Pain Society
Washington, DC
May 2-5
www.ampainsoc.org
Southwest Oncology Group Spring Meeting (SWOG)
Chicago, IL
May 2-6
www.swog.org
American College of Ob/Gyn
Washington, DC
May 6-10
www.acog.org
World Conference on Interventional Oncology (WCIO)
Washington, DC
May 14-18
www.wcio2006.com
American Thoracic Society/American Lung Association
San Francisco, CA
May 18-23
www.thoracic.org
American Psychiatric Association (APA)
San Diego, CA
May 19-24
www.psych.org
American Urological Association
Anaheim, CA
May 19-24
www.auanet.org
Digestive Disease Week
Washington, DC
May 19-24
www.ddw.org
American Society for Microbiology (ASM Annual)
Toronto, Canada
May 21-25
www.asm.org
JUNE
American Society of Clinical Oncology (ASCO)
Chicago, IL
June 1-5 703-299-0150
www.asco.org
Associated Professional Sleep Societies
Minneapolis, MN
June 9-14
www.apss.org
European Congress of Rheumatology (EULAR)
Barcelona, Spain
June 13-16
www.eular.org
European Generics Medicines Association (EGA) Symposium on Biogenerics
Istanbul, Turkey
June 14-17
www.egagenerics.com
European Neurological Society (ENS)
Rhodes, Greece
June 16-20
www.ensinfo.com
European Society of Hypertension
Milan, Italy
Jun 17-21
www.eshonline.org
International Generic Pharmaceutical Alliance (IGPA)
Monaco
June 19-21
www.egagenerics.com
American Society of Ophthalmic Plastic & Reconstructive Surgery (ASOPRS)
Key Largo, FL
June 21-24
www.asoprs.org
American Diabetes Association
Chicago, IL
June 22-26
www.diabetes.org
American Medical Association (AMA)
Chicago, IL
June 23-27
www.ama-assn.org
AUGUST
American Psychological Association
San Francisco, CA
Aug 17-20
www.apa.org
SEPTEMBER
European Society of Cardiology (ESC)
Barcelona, Spain
Sept 2-6
www.escardio.org
American Society for Bone & Mineral Research (ASBMR)
Honolulu, Hawaii
Sept 16-20
www.asbmr.org
Interscience Conf on Antimicrobial Agents & Chemotherapy (ICAAC)
Chicago, IL
Sept 17-20
www.icaac.org
International Diabetes Federation Congress / European Association for the Study of Diabetes
Amsterdam, Netherlands
Sept 17-21
www.easd.org
OCTOBER
American Neurological Association (ANA)
Washington, DC
Oct 7-10
www.aneuroa.org
American College of Emergency Physicians (ACEP)
Seattle, WA
Oct 8-11
www.acep.org
American College of Gastroenterology (ACG)
Philadelphia, PA
Oct 12-17
www.acg.gi.org
American Society for Reproductive Medicine (ASRM)
Washington, DC
Oct 13-17
www.asrm.org
American College of Chest Physicians (ACCP)
Chicago, IL
Oct 20-25
www.chestnet.org
American Academy of Child and Adolescent Psychiatry (AACAP)
Boston, MA
Oct 23-28
www.aacap.org
United European Gastroenterology Week
Paris, France
Oct 27-31
www.uegf.org
American Society of Nephrology (ASN)
San Francisco, CA
Oct 31-Nov 5
www.asn-online.org
NOVEMBER
American Association for the Study of Liver Diseases
Annual Meeting
Boston, MA
Nov 2 - 6
Society for Neuroscience
San Diego, CA
Nov 3-7
www.sfn.org
American College of Allergy, Asthma & Immunology
Dallas, TX
Nov 9-14
www.acaai.org
American Academy of Ophthalmology (AAO)
New Orleans, LA
Nov 10-13
www.aao.org
American College of Rheumatology (ACR)
Washington, DC
Nov 10-15
www.rheumatology.org
Gerontological Society of America
San Francisco, CA
Nov 16-20
www.geron.org
Radiological Society of North America
Chicago, IL
Nov 25-30
www.rsna.org
American Epilepsy Society
Philadelphia, PA
Nov 30-Dec 4
www.aesnet.org
DECEMBER
Osteoarthritis Research International Society
Miami Beach, FL
Dec 6-9
www.oarsi.org
American Society of Hematology (ASH)
Atlanta, GA
Dec 8-11
www.hematology.org
American College of Neuropsychopharmacology (ACNP)
Boca Raton, FL
Dec 9-13
www.acnp.org
San Antonio Breast Cancer Symposium
San Antonio, TX
Dec 13-16
www.sabcs.org
American Association for Respiratory Care
Orlando, FL
www.aarc.org
Could you take this discussion to a penny stock board or at least provide a rationale for why you like AEMD beyond the fact that it is "on the radar for volume increase." This is not the place for penny-stock spam.
I didn't say that one was the one I was looking for...just that I'd like one that I can sign up for and receive alerts on my favorite stocks.