Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Regarding your survey, I'd like to see an analysis on how good our consensus opinion reflects what actually happens. Given that there are some very astute posters on this board, BV surveys may be a useful investment tool.
PS: RPRX wins over ITMN by a nose. I'm not counting SCLN as a BV stock since I haven't seen any recent posts on it.
ITMN
Good day for I-Hub. Any one check ITMN in the last few minutes?
!!!
>RPRX taking off. A tiger in the tank. Realization (valuation) is finally occurring.<
I'm going to go take a cold shower.
>I’ve found that the branded pill seems to work better, but this could be a placebo effect.<
This is just from memory, but generics can deliver +/- 10% of active drug and still be approved. I'll check in with a contact to see if this memory is just a hallucination on my part.
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: Added anticipated dates for final results from 3 RPRX trials
ACHN – See GILD
ADLR – Approvable letter for Entereg issued 11/6/06 requesting safety data due in 2Q07.
AGIX - ARISE final lock starts in Aug 06, trial results expected to be released in "Early 07".
AMGN – Vectibix PACCE non-registrational trial in 1st-line CRC (Avastin+FOLFOX+/-Vectibix) RR Jan 07 (at quarterly CC); PACCE PFS 2Q07. Vectibix final OS from ‘408’ study: 4Q06 (low chance of hitting endpoint).
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 2nd half 06.
ASPM – Interim data from BRITE trial in depression: scientific conference in 2Q07.
BMY – Plavix trial begins 1/22/07.
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 – Actilon for HCV: 1) SVR data for 20 continuing patients (out of a total of 74 patients) in the phase-1b relapsed-responder trial 1H07. (12-week data for this trial were reported Apr 2006: #msg-10881211.) 2) Some 12-week interim data from the lead Actilon trial, the phase-2 for null responders, by end of 2006.
CONR: see JNJ.
COR – CX717 completed toxicology data: Jan 2007. (FDA clinical hold was lifted 10/9/06.) Go/no-go decision on CX-717: Feb/Mar 2007.
CORT – Phase-3 trials of Corlux for psychotic major depression: ‘06’ trial results 4Q06. (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: priority-review determination by 1/12/07; advisory panel expected in March 2007; PDUFA date mid-May 2007 (assuming priority review).
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 4Q06.
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: 2Q07.
GTCB – ATryn DIC program in EU: start of ph-2 (by Leo Pharma) 4Q06.
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: sometime in 2007 at a medical conference.
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) Erbitux in CRC. a) PFS in 1st-line CRSYTAL trial: 1Q07;
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 enrollment fall 06, trial complete 18 months later. (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.
RPRX
All due end of March 2007
1) Phase II final results for Proellex in endometriosis
1) Phase II/III final results for Proellex in uterine fibroids
2) Phase III final results for Androxal
SGP – Ph-2 data for SCH 503034 in HCV: 2H07
SNY – Acomplia PDUFA date: 4/26/07.
SNY – Plavix 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).
TELK – ASSIST-1 -2 and -3 phase-3 results: 4Q06 (all 3 to be announced simultaneously).
TH.TO -Begin confirmatory TH9507 HIV Associated Lipodystropy trial 1st qtr/07
VRTX – PROVE-1/PROVE-2/PROVE-3 timetable: see #msg-12267294
YMI – Tesmilifene ph-3 breast cancer: 2nd data look on 8/22/06 did not meet pre-specified threshold for either success or failure; 3rd data look pending.
YMI – AeroLEF final results 4Q06 (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.
>Androgenetic alopecia is presumably a side effect of a drug that boosts testosterone levels on a sustained basis. Is this considered an AE in the Androxal trial?<
I don't know, but yes you are right: increased testosterone levels may accelerate hair loss.
I read a long time ago in a major journal that scientists have the highest testosterone levels of all professions, including professional athletes. Which explains all the shiny heads at scientific conferences.
Various other articles indicate that high testosterone levels are also associated with hair loss, allergies, and nearsightedness.
It always seemed unfair to me that the guys with the highest testosterone levels were condemed to be bald, near-sighted, and allergy-prone.
RPRX
Okay, now that I’ve had some time to review the data from the UF trial, here are my thoughts.
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 spectacular results, with P values of .0046 and .0029, respectively. Given that QoL measures are notoriously squishy, I did not expect this result. I expected a trend toward improved QoL.
3) Pain scores. Again spectacular, particularly at the 25-mg dose (P=0.006). Again, I did not expect this result as a) in the previous trial the 50-mg dose provided the most impressive reductions in pain and b) the 50-mg dose in the endometriosis trial was the only one that provided reductions in pain. I know I shouldn’t extrapolate from one disease state to another, but these were the best data I had to go on.
4) Great safety results, which really were the key to this trial. Seven placebo patients, six 12.5–mg patients, and three 25-mg patients had thickening, which is really quite impressive. Most importantly, no hyperplasia with atypia was observed in any patient.
5) No results for the secondary end point of fibroid size. I don’t know why, but I am not particularly concerned about it.
All in all, I am extremely comfortable with this investment and I have my head well above water.
Given that 1) there are 13.6 million women in the US with UF, and 25% need treatment and 2) there are 5.5 million women in the US alone with endometriosis and no good treatment, Proellex has the potential to be a near-blockbuster, and in the appropriate hands (eg, mine) it could be a formal blockbuster. Add to that 3) $150 M starting market for Androxal in Europe and RPRX is far undervalued.
I would be quite comfortable buying this even if it doubled to $150 M. I am disappointed that the market does not recognize the potential here; a tremendous amount of risk has been taken out of this program. But strange things happen to stocks when you have the amount of hedge fund involvement RPRX has.
Now I'm going to stop thinking about RPRX for a few months. The one negative side effect of Proellex and Androxal is investment-related alopecia, and I need time and expensive hair-care products to recuperate.
>Re rfj advising friends re RPRX. You're good at this investing gig. They won't be as nimble or well informed. They're probably in low tax brackets. I'd talk to them about stop losses and such. It'll probably hit 8 today and most of the news is in. Hmmm. When will the management sell out?<
Thanks for the advice, but the friends I discuss these things with are either in biotech/pharma or in finance, so they're perfectly capable of making their own decisions.
I'd never recommend this, or any biotech, to gramps.
If you examine the insider purchase prices, I think you'll find that management won't be selling anytime soon.
Regarding news: the fun starts anew in March. Not so long to wait.
RPRX
Groggy again, but I believe these results exceed my wildest expectations. RPRX *should* open at $15 and go up from there, but we all know that's not going to happen
>Think your 50, 25, 25% plan sounds logical.<
Actually, I think it's risky. I told my friends fun money before the results, a little more after the results, and all in after the financing. It might be even more prudent to go all in after the final results in March. I'd rather have them mad at me for not making money than for losing money.
Regarding your other question: I plead the Fifth on low-volume, low-float stocks.
Spartex,
>Will you still be providing any updates and analysis on PRs by RPRX on IHUB? Your summarys (field guide) have been very useful to myself and others.<
I have my own business, so it's not as simple as throwing my hands in the air and yelling "I quit!" So school is 2 years down the road. I did feel it was prudent to start moving into safer investments well in advance. I'd hate to be accepted only to suffer an NFLD event a couple days before school starts!
Regarding RPRX share price: While I can provide a reasonably well-informed answer to clincal questions (often with the help of Google and PubMed) you're asking the wrong person about short-term financial catalysts.
But here's what I'm thinking: remember that they do not have a 50-mg dose in the uterine fibroids trial. So while it is highly likely that the primary end point (bleeding) will be positive, there is a possibility that endometrial thickening will be seen in this trial.
Note, however, that they double-dosed up front, so if the saturation hypothesis is correct then there won't be thickening at this dosage.
My personal expectation for this trial is that thickening will be seen at both the 12.5 and 25 mg dosages, with a strong trend toward less thickening with the 25-mg dose. I would expect that a 50-mg dose will be included in subsequent uterine fibroid trials.
I also think that you're correct that the pending secondary is holding down the price. As it should. But I suspect there will be a lot fewer shares for sale than potential PIPE participants expect. In short, if the UF results are positive, I'd expect a relief rally after the secondary.
What would be truly beautiful is if they partner Androxal in Europe and get enough money to hold off on the financing. Then it's look out above. I don't expect this to happen, but a boy can dream, right? (Again, assuming the UF results are positive).
As far as my strategy, I've allocated a specific dollar amount to my RPRX investment. I'm 50% in, will buy another 25% provided everything goes okay with the UF trial, and another 25% after the offering.
My recap:
I too had a less-than-stellar 2006, although it started out with the bang from hell.
In mid-March, I was up 76% for the year. As of today, I'm up only 25%.
Thanks goes out to YMI, XNPT (twice), DVAX (twice). All 100%+ winners (XNPT and DVAX are 100%+ in two round trips each). Also HNAB, which wasn't a 100% winner but I had a big investment in it.
No thanks goes out to COR, CORT, and ENCY, all of which I lost ~40% on. I also lost a significant amount on <10% losers while testing the waters during the mid-year slump. POTP wasn't great either.
I was short on both AVNR and NBIX at various times, and made only trivial amounts on both. For some reason I'm easily scared out of my short positions.
I also moved around 60% of my assets to safe non-biotech because I'm planning on closing up shop soon and going back to school. Then, to avoid temptation, I moved all of my non-biotechs to another brokerage to limit the temptation to use them as leverage.
My new year's resolutions:
1) Hold on to my shorts
2) Avoid any stocks that start with the letter C.
All in all, not terrible but not great, particularly in the context of my gains during the first quarter. I'll never match 2005 or probably even 2004.
Finally, two thank-you's:
1) Thank you to the posters on I-Hub. I work in industry and have a ton of friends in finance (given that I live in banker central), but the stuff many of you post is far more incisive than many of the things I hear from the pros. I won't name names because I don't want to leave anyone out.
2) Thank you to David Miller and BTM. Again, even though I'm in the business BTM has been a fertile source of ideas. I may agree or disagree with his picks, but it's always interesting.
>OK, but showing non-inferiority to AndroGel would seem to leave RPRX in a no man’s land where they’re at a disadvantage to both AndroGel and Testim: the former in terms of marketing muscle and the latter in terms of efficacy.<
Regarding marketing muscle: guess that depends on who gets the program, eventually. RPRX isn't going to market this themselves.
Regarding efficacy: remember that T-gels have very serious limitations, including, but not limited to, secondary hypogonadism, partner risk, abuse potential, infertility, and shrunken testicles.
In short, Androxal doesn't have to be as good as Testim to more or less completely supplant it from the market. And I'd suspect you'd need a huge head-to-head to demonstrate significant superiority for Testim over Androxal anyway.
>Question for RPRX longs: Why is Androxal being compared to AndroGel instead of being compared to Testim?<
Marketing expediency.
2005 sales for Testim were $43 million. 2005 sales for Androgel were $326 million.
Always compare to the market leader.
RPRX
>I believe that increased T, back to normal or low normal, will qualify as a clinical endpoint in and of itself.<
Belief is good, but I would suggest you review the company's presentations before making that statement.
***Proud graduate of Columbia University: Valuing Academic Infighting, Inattentive Mentors, Indentured Graduate Students, and High Research Overhead***
RPRX
These data are very good.
Testosterone levels improved to a point where even the interim analysis indicates that this trial was a statistical success. There was a dose-related trend toward improvement in distress, which is really all I expected at this point.
What this result says to me is that Androxal will almost certainly be approved eventually ex-US, where there is no requirement for a BS clinical end point. Eventual approval in the US is open to question, but given that there are several T-replacement therapies out there with serious drawbacks, I'd suggest the FDA will consider Androxal, in clinical context, as a safer alternative.
However, based on just this statement:
With these encouraging results in hand, we will seek to identify a licensing partner for Androxal in Europe.
The stock deserves a much bigger bump than it is getting. 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.
RPRX is ridiculously undervalued. It should be worth $100 M+ right now, and $200 M+ with positive uterine fibroids data. Guess people would rather gamble on NFLD and DNDN.
So McKinsey reads I-Hub too!
Cougar,
Thanks for the article.
The good (meaning actionable for investors):
...an even more significant predictor of failure was novel mechanism. Even after the patient evaluation process in Phase II, drugs that used novel mechanisms of action failed more than twice as often in Phase III as those that used known mechanisms. And if drugs had both novel mechanisms and less objective endpoints, they failed 70% of the time. In contrast, drugs with validated mechanisms and objective endpoints failed just 25% of the time.
The bad:
The basic problem is wishful thinking. Sometimes project teams lose their objectivity about compounds, because they have worked on and championed them for years. Another reason is that senior managers bow to Wall Street: many feel pressure to deliver on their announcements, despite the uncertainties caused by the technical risks and subtleties of drug discovery. Some have announced pipeline goals with incentives of senior management tied to meeting targets around numbers of compounds in different stages.
The amusingly ugly (this is why the McKinsey folks get paid the big bucks):
Lower-risk compounds could benefit from groups that focus on making operations more efficient, speeding the drugs' passage to market. Higher-risk compounds might benefit from teams led by people with unusually good scientific and business judgment, who would be able to ensure that unpromising compounds are killed early. Given the fact that fewer of these high-risk drugs are likely to be successful, these team leaders may be able to manage several projects simultaneously, thus reducing costs.
Urche,
As you may be aware, there was an article in this month's Cell about Resevratrol (or however you spell it)....sorry, forgot to post on it.
J
PANC might be an opportunity; I think the selloff is way overdone considering this is most likely a formulation and not an efficacy issue. Assuming they can get the formulation right.
NFLD is dead.
>$160MM is hardly an earth shaking capitalization.<
You're probably right. I'll wait for the dust to settle, though.
>How will he deliver the drug to the metastases?<
Obviously there's no way to target micrometastases, but any tumor that's visible will be injectable.
The nice thing about TNFerade--and correct me if I'm wrong--is that the MOA is not tumor specific. I would suspect that if these results hold up the drug will be huge and sales will be driven by off-label use.
Wish I owned it. I considered it, never got around to buying.
RPRX
Blinding for an oral vs injectable is simple: just do a double-dummy study in which all patients get poked with a needle and all patients take daily capsules.
>guess what I'm wondering is how realistic is a takeover when the primary driver for the acquiring company seems to be a comparison of 8 women at one proellex dose against 8 women on lupron?<
It's not realistic based on the data from the endometriosis trial.
But if the uterine fibroids data (much larger trial) are positive, then yes it becomes a real possibility if management is game.
I'm not asking for a billion, just $200M or so. Pocket change.
RPRX
Don't thank me until the fibroids results are in. Although in the long run uterine fibroids represents a signficantly smaller market than endometriosis (1.5M vs 5.5M patients, plus Proellex is more likely to be used chronically and long-term for endometriosis), uterine fibroids is the nearer-term opportunity for RPRX.
Regarding the CMO: this doesn't stop big pharma from taking a run at RPRX anyway. I've already spammed my friends and colleagues in industry
Frankly, I don't want to wait for this to be a billion-dollar company, which it will be if they successfully execute on Proellex alone. I'd rather skip the risk and take $200M.
RPRX
Now that I'm fully awake and have had a chance to read the press release a few more times, I'm even more enthusiastic:
Keep in mind that Proellex does not need to show superiority to Lucrin to be a viable drug. Comparability is just fine. But that's not what was seen...it's better than that.
1) The 50-mg dose was statistically significantly better than Lucrin in terms of days of pain (P=0.02). Really 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) Even 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 an incredible result for pain-associated distress, with a P-value of 0.001 vs Lucrin for the 50-mg dose. In fact, only one woman reported mild distress in the Proellex group.
All in all, the efficacy results are so much better than Lucrin it's ridiculous. I expected good results, but not this good.
4) Regarding safety, as expected there were no signifiacnt 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 signficant endometrial thickening at any Proellex dose and no endometrial hyperplasia with atypia at any dose.
In short, when taken the data are taken seperately or together this was an incredibly successful trial. Proellex is so much better than Lucrin in this application it's ridiculous. Given that endometriosis is a market with signficant unmet needs, this stock should be a huge winner over the long term.
Sorry for all the underlines and enthusiasm--I've been waiting for this result for months.
RPRX
These results couldn't be better. In fact, unless my groginess is interfering with my thinking they're better than my best-case scenario. More later, I'm going back to bed.
J
My 15-minute take on your list. Left out a few that are too obvious (like VLTS).
I wouldn't buy any of them, but if I had to, I'd buy NBIX or AVNR.
COR
Someone else can comment on this one. I’ll keep my mouth shut.
CORT
Absolutely hopeless. RU486 has no effect on psychotic depression, and the company doesn’t have anything in the pipeline.
DOVP
I don’t know much about DOVP, and their website is confusing as hell. No idea here if the pain drug is promising or not.
ICGN
No hope here either since hydroxyurea failed. Although they have several drugs and leads in preclinical development, it’s going to be a long, long time before this moves.
INHX
DOA, since Veronate, their drug for prevention of staph infections in very-low-birth weight infants, is a mechanistic failure. Can’t believe this one every made it past the concept stage.
NBIX
The dust might have settled sufficiently to pick this one up. As of third quarter they had 404 million, or about 4 years at the current burn. They have a bunch of stuff in the pipeline (GnRH antagonist, urocortin for CHF, and an SNRI for neuropathic pain).
NEOL
Dead. Their glioblastoma drug is a complete failure, and the next best thing they have—“me too” liposome entrapped paclitaxel-- is just entering phase II.
NTMD
Don’t know enough about BiDil to have an opinion.
OCCX
Isn’t this the rheopheresis company that Cramer pumped? This will never go anywhere—in order to make any money, any treatment based on apheresis has to show outstanding efficacy given the cost and time involved in the treatments. This won’t.
RNVS
Dead. But they’ve got lots of cash. Maybe POTP should “merge” with them.
THLD
Gone. Does anyone really think glufosfamide is going to show efficacy in pancreatic cancer?
This is really amazing. If anyone has free access to Cell, please send me a PDF.
Speaking of corporate logos...
My favorite:
When I visited this company, I actually went to the company store and bought a T-shirt. If this wasn't a corporate logo, I'd have a blue bull tattoo.
Novo-Nordisk vs Amlyn
Anyone have thoughts about liraglutide vs Byetta?
>Since there are many more medical GP’s than there are specialists, your plan of allocating the brightest reps to serving GP’s would seem to be mathematically untenable.<
Agree given the current composition of sales forces. But more time and resources devoted to training representatives will naturally raise the mean. As would more frequent testing (think "No Rep Left Behind") and ruthless culling of reps that aren't performing up to standard.
Cutting back on sales forces, as Pfizer has done, may rectify the problem. Unfortunately, I suspect they'll cut their training budget proportionally.
In short, I guess what I was saying is that the specialty reps could very well be limited to a "drop off the samples" call because, let's face it, a rep isn't going to change a specialist's mind about a drug. Instead, marketing to specialists could be limited to web and mail delivery of substantive new data.
On the other hand, a rep that can bring reprints and new data to the attention of a primary care provider would provide significant added value to that physician's practice.
What's wrong with Big Pharma?
Let me tell you what's wrong with big pharma, with particular reference to the graphic.
It is unsurprising that out of 100 reps only 25 have a meaningful, two-way discussion with physicians.
Why is it unsurprising? It's tough to have a meaningful conversation when your response to most questions is "Doctor, I can't answer your question, but if you call 1-800-XXXX our medical information department will provide you with the answers you need."
For regulatory reasons, reps are now trained to give very risk-focused presentations. To give you one example, during a recent antidepressant launch, about 25% of a full call was devoted to efficacy and clinical data, and the remaining 75% was devoted to a long, long list of every possible thing that could go wrong as well as a detailed exposition on the product's risk management program. Reps were monitored and evaluated on their delivery of the full risk message.
Also for regulatory reasons, many reps are inadequately trained. Why? Because every piece of educational material that goes to a sales rep has to be vetted by regulatory and legal. As one might expect given the regulatory environment, regulatory and legal staff at big pharma are extremely risk focused. In all too many cases, this means that the meat of rep educational material is removed and replaced with bland language that has little educational value.
This isn't the fault of big pharma, nor is it the fault of DDMAC and other regulatory bodies. But put them together and you get a feedback mechanism that dilutes the value of the rep/physician interaction.
In short, if you can't say anything of value, why not just stop by and drop off some samples and a PI?
In many ways, big pharma has their hierarchy of reps backwards. The most experienced reps sell to specialty. These guys usally have enough knowledge that they can have a high-level discussion with a customer about their therapeutic area. But they're generally preaching to the choir.
On the other hand, most mass market reps (who sell to PCPs) are inexperienced. A mass market representative with the level of knowledge of a specialty representative might be able to bring real value to PCPs, who see patients with a broad spectrum of conditions and who generally don't have time to keep up with every advance in every therapeutic area.
If any docs on this board have made it this far, I'd be interested in what you have to say. Urche? Xrymed? Dewophile?
OT: More amusing antiscientific right-wing BS
http://www.wnd.com/news/article.asp?ARTICLE_ID=53327
IDP
Closed flat as a pancake. Should have taken my $2000 and run.
Looking at ANSV, IMM, IOMI, and XTLB, if anyone would care to warn me off before I start serious DD.
IDP
After my success with DVAX, I was looking around for other companies in the TLR space, and came up with IDP. I ended up buying a little last week, and now it seems that's all I'll be buying because it's gotten away from me.
***********************************************
Merck, Idera Agree to Vaccine Tech Pact
Monday December 11, 10:44 am ET
Merck, Idera Pharmaceuticals Agree to Development Pact for Vaccine Technology
NEW YORK (AP) -- Drug maker Merck & Co. and drug developer Idera Pharmaceuticals Inc. said Monday they agreed to collaborate on developing technologies that could be applied to vaccines for cancer, infectious diseases, or Alzheimer's disease.
Idera shares hit a new 52-week high, jumping $1.19, or 21.2 percent, to $6.80 in early morning trading on the American Stock Exchange at double their average volume. Shares, which reached a high of $6.99 earlier in the session, have traded between $1.60 and $5.92 over the past 52 weeks.
Merck, Whitehouse Station, N.J., will make an upfront license fee payment of $20 million and buy $10 million in Idera common stock at $5.50 per share. Idera's technology attempts to improve the Toll-like Receptor function in immune cells. The receptors act as sensors for bacteria, viruses and parasites, and counter with an appropriate response.
Idera, Cambridge, Mass., could make up to $165 million in milestone payments if vaccines are successfully developed in all three fields, and up to $260 million more in milestones if follow-on indications for cancer are developed. Idera is also entitled to royalties on product sales.
The companies will collaborate over two years on research and development to find compounds that use two kinds of Toll-like Receptors.
Merck shares rose 14 cents to $44.07 on the New York Stock Exchange.
NUVO, NEOL, etc.
Bad day, I guess, for Medical Technology Stock Letter. Last I saw, these two companies were their top picks.
THLD
Can someone tell me why THLD is a $111 million company. They have nothing of value aside from $50 M in cash and a crap drug, which according to Reuters is being tested in "pancreative" cancer.
Stogi,
Conventional wisdom, as I understand it, is that interposing the weekend between an announcement and the first chance to respond will blunt the response to the announcement.
So if a company can hold negative results until Friday after the bell, the immediate selloff may be attenuated by the chance to have the weekend to rationalize holding the stock.
Obviously this is feeling not fact, there's no way to conduct a controlled experiment.
RPRX
I just hope they don't announce results tonight.