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Teva Gets Approval on Generic Aciphex
Thursday February 22, 10:59 am ET
Teva Pharmaceutical Industries Receives Final FDA Approval on Generic Aciphex
NEW YORK (AP) -- Generic drug developer Teva Pharmaceutical Industries Ltd. said Thursday the Food and Drug Administration approved its generic version of Eisai Co.'s heartburn drug Aciphex.
Israel-based Teva is involved in a patent lawsuit with Eisai over the delayed-release, 20-milligram tablets. A trial in the U.S. District Court for the Southern District of New York is scheduled for March 5.
Shares of Teva fell 43 cents to $37.92 on the Nasdaq Stock Market in morning trading.
7:03AM Compugen announces discovery of eight novel G-protein coupled receptor peptide ligands (CGEN) 2.61 : Co announces that it has developed a GPCR ligand discovery engine and that use of the engine to date has resulted in it's discovery of eight novel peptides that activate GPCRs. Co announces the new peptide ligands will be presented at Screening Europe and at CHI's Molecular Medicine Tri-Conference.
Tysabri had a nice start but it is not a threat to Copaxone in the near future here are a few points that Citi did not mentioned:
Tysabri is not a first line treatment, one has to fail the first line before switching to Tysabri.
The production ability of Tysabri is limited after Biogen sold the main facility that was suppose to produce it to Genentech.
Tysabri's cost is $28,400 per year, higher than the competitors.
Teva is testing high dose (44mg)of Copaxone in phase III and also
a new drug-Laquinimod (that might be the first oral drug for MS).
<NVS and MNTA have not said—and do not plan to say—exactly what the patent-litigation strategy will be.>
I assume that means a long fight in court and a perhaps a longer Via-Dolorosa until FDA approval.
Do you know when will the Copaxone patent expire?
From Credit Suisse report, analyst Marc Goodman, 14 February 2007
(If someone wants the full report, please PM me your email).
Solid Guidance; It's Amazing How Low Expectations Were
Our Takeaway.
We were surprised by the follow through in the stock especially after the recent
run up. We attribute it to the guidance for the 2007-2009 period, which was
basically in line with our estimates; however, we obviously didn’t appreciate how
low investor expectations were for the numbers.
With respect to 2007, the year is heavily back-end loaded and we have to
assume Teva will be doing additional deals like it did with Wellbutrin XL in order
to achieve much higher than the low end of its guidance range. In fact, we have
to admit, we struggle to even see how it can reach the bottom of the EPS
guidance range given what we know today.
We have been fairly positive on the stock recently in the low $30s, believing that
growth in the international business as well as the respiratory franchise is
underappreciated. We still think that this is the case, but given that the market
appears to have blessed the $2.50 in 2008 and $3.00 in 2009 company EPS
forecasts, and we don’t see significant upside to those numbers, it is difficult to
be excited about the name at $37.
Our year end price target has increased modestly to $40, based on a 15x P/E
multiple of our 2008e cash EPS estimate of $2.67 (equivalent to a 16x P/E
multiple of our 2008e GAAP EPS estimate of $2.54).
From Credit Suisse report (analyst Marc Goodman, 14 February 2007
(If someone wants the full report, please PM me your email).
Solid Guidance; It's Amazing How Low Expectations Were
Our Takeaway.
We were surprised by the follow through in the stock especially after the recent
run up. We attribute it to the guidance for the 2007-2009 period, which was
basically in line with our estimates; however, we obviously didn’t appreciate how
low investor expectations were for the numbers.
With respect to 2007, the year is heavily back-end loaded and we have to
assume Teva will be doing additional deals like it did with Wellbutrin XL in order
to achieve much higher than the low end of its guidance range. In fact, we have
to admit, we struggle to even see how it can reach the bottom of the EPS
guidance range given what we know today.
We have been fairly positive on the stock recently in the low $30s, believing that
growth in the international business as well as the respiratory franchise is
underappreciated. We still think that this is the case, but given that the market
appears to have blessed the $2.50 in 2008 and $3.00 in 2009 company EPS
forecasts, and we don’t see significant upside to those numbers, it is difficult to
be excited about the name at $37.
Our year end price target has increased modestly to $40, based on a 15x P/E
multiple of our 2008e cash EPS estimate of $2.67 (equivalent to a 16x P/E
multiple of our 2008e GAAP EPS estimate of $2.54).
Democrats submit bill to allow biologic generics in U.S.
14.2.07 | 21:40 By Yoram Gavison
http://www.haaretz.com/hasen/spages/826127.html
Shares in Teva (TASE, Nasdaq: TEVA) are rising 1.8% on Wall Street as of writing, fueled by hopes of a bill that could break through the barriers stopping the approval of cheaper, generic biotech drugs known as biologics.
Democratic senators Charles Shumer and Hillary Clinton, both of New York, tabled a bill today that would empower the U.S. Food and Drug Administration to approve generic biologics made from living cell cultures. Regular generic drugs are made by chemical synthesis.
Because of the biological production process, it is harder to guarantee consistent quality of biologics, and that they will remain identical to the original drug.
That conundrum has held up approval of biological generics in principle in the U.S., creating an ever widening gap between the American and European healthcare systems.
Sales of biologics reached $24 billion in 2005, or 9.5% of the U.S. prescriptions market.
See also Dew's post:
http://www.investorshub.com/boards/read_msg.asp?message_id=17057467
Teva 4Q Profit Rises on New Products
Tuesday February 13, 8:40 am ET
Teva Pharmaceutical Industries Sees 4th-Quarter Profit Rise New Drugs and Ivax Acquisition
NEW YORK (AP) -- Generic drug developer Teva Pharmaceutical Industries Ltd. said Tuesday its fourth-quarter profit rose 51 percent on sales of new products and the inclusion of the Ivax acquisition.
The Israel-based company earned $460 million, or 56 cents per share, compared with a profit of $305 million, or 45 cents per share, during the same period a year prior. Revenue rose 63 percent to $2.28 billion from $1.4 billion.
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Analysts polled by Thomson Financial expected profit of 58 cents per share on revenue of $2.26 billion.
North American sales accounted for 59 percent of the total quarterly sales, with antidepressant drug Bupropion XL leading sales of 18 new products, the company said. Another antidepressant -- Venlafaxine -- was also among the new drugs on the market in the fourth quarter.
revenue also gained from higher sales of multiple sclerosis treatment Copaxone and the introduction of Azilect in the U.S. and Canada for Parkinson's Disease.
For the full year, the company earned $546 million, or 69 cents per share, compared with a profit of $1.07 billion, or $1.59 per share, in 2005. Revenue rose to $8.41 billion from $5.25 billion.
In January of 2006, Teva paid more than $7 billion to buy rival generic drug developer Ivax Corp.
Teva shares rose 64 cents to $36 in premarket activity.
http://biz.yahoo.com/ap/070213/earns_teva.html?.v=1
I don't think it was bait and i still hold 60% of my TARO position hoping it will be bought. I may be wrong, everything is possible but this is the name of the game no?
genisi
Bioline-
This is apparently the best Israeli incubator so far. These guys are having some interesting people on board such as Professor Ciechanover who is a recipient of the 2004 Nobel Prize in Chemistry. That might explain the puffy headline.
Great company with an outstanding CEO, i"m watching them.
http://www.globes.co.il/serveen/globes/docview.asp?did=1000181314&fid=942
QBI plans Nasdaq IPO
Quark Biotech wants to raise $70 million at a value of $300 million.
Tali Tsipori 8 Feb 07 18:07
Sources inform 'Globes' that drug discovery start-up Quark Biotech Inc. (QBI) is planning an IPO on Nasdaq. The company wants to raise $70 million at a value of $300 million, although the final amount has not yet been decided, and has already met underwriters for this purpose. Procedures for the IPO will begin in a few weeks.
Speaking on behalf of QBI, Yaron Garmazi said, “An offering is one possibility being thoroughly considered.” Garmazi is considering joining the company as CFO. He has served as CFO for several Israeli companies that held IPOs, mergers or acquisitions, including Passave, Ness and Envara.
QBI made news last year when it signed a strategic agreement with Pfizer Inc. (NYSE: PFE; LSE: PFZ), which invested an initial tens of millions of dollars in the company, and could invest several hundred million, in exchange for development and marketing rights to QBI’s treatment for age-related macular degeneration (AMD). QBI achieved its first milestone under the agreement when the drug began Phase I clinical trials a few days ago.
QBI is also the only Israeli company in which Oracle founder Larry Ellison has invested in. He was one of the company’s first investors and has backed it for over a decade.
QBI is unusual among Israeli companies in that it one of the few companies that develops drugs from the initial laboratory stage through clinical trials. The company’s links to Japan are also unusually close; most of its capital has come from Japanese venture capital funds and corporations.
OT- pc security
<Norton Internet Security attempts to turn auto-update back>
That is one among many reasons that made me abandon Norton and switch to Kaspersky.
IBI take on TEVA:
Market is worried about Teva's guidance for 2007, says IBI
08.2.07 | 12:11 By Nathan Sheva
On Tuesday Teva Pharmaceuticals (TASE, Nasdaq: TEVA) will be publishing its results for the fourth quarter of 2006. Although it had a terrific year, its share price sank by 33%, in part because of anticipation that growth in 2007 will be slower. Teva already stated back in the third quarter that it expects single-digit growth this year, but this year its stock has rebounded by 14% nonetheless, partly due to expectations that 2008 will be better.
Israel Brokerage & Investments chief analyst Elah Alkalay is not expecting any surprises in the fourth-quarter statement. Its guidance for the year 2007 will be key, she believes: a Teva forecast above or below the Wall Street consensus will have a strong effect on its share price.
That consensus is presently that Teva will be reporting $8.89 billion sales in 2007, and earnings per share of $2.16 per share.
Regarding the last quarter, IBI predicts $2.44 billion in sales and net profit of $483 million, or 50 cents per share.
For the first time, Teva will be releasing information on Copaxone sales together with its financial statement. Usually the company preannounces the performance of Copaxone, its proprietary treatment for relapsing/remitting multiple sclerosis.
IBI believes that fourth-quarter sales of the drug will have grown 16% to $374 million in 2006.
http://www.haaretz.com/hasen/spages/823635.html
This really sounds like science fiction at first but actually they are on solid ground. They developed an oxygen generating power plant (seaweed), the generated oxygen will then provide life support to beta-islet cells. The cells will produce insulin and will also generate CO2 that will be captured by the seaweed and so on and forth...
I am sure someone will do it better and quicker elsewhere, but the idea is great.
Dubi, you will have your entry point :)
Compugen will need more cash by mid-2009
06.2.07 | 15:07 By Omri Cohen
Biotechnology company Compugen (Nasdaq: CGEN) racked up more losses in the last quarter of 2006.
In fact, its loss widened by 15% to $3.8 million in the last quarter, compared with $3.4 million in the same period of 2005.
However, it managed to make $10,000 in sales, compared with zero in the parallel quarter.
Compugen ended 2006 with $26.4 million cash.
The company said it expects to post expenditure of $12-14 million in 2007, and net cash burn of $9-11 million. By the end of the year it should have $16 million left.
Assuming that Compugen doesn't find a new source of income this year or in 2008, the company will have to raise more money by mid-200
If Templeton will buy Prutalix I'll know for sure that they are tapping my phone
TEVA- more possible acquisition gossip.
http://www.haaretz.com/hasen/spages/822519.html
Teva's competing with Novartis to buy India's Aurobindo - report
06.2.07 | 08:42 By TheMarker
Teva Pharmaceuticals (TASE, Nasdaq: TEVA) is competing with Novartis to buy the Indian drug company Aurobindo Pharma, the Hindustan Times reports.
A deal over the Hyderabad-based maker of oral and sterile antibiotics is close, the paper claims.
Israel-based Teva, the biggest maker of generic drugs in the world, has long been rumored to be looking for an Indian company to buy.
The Times notes that Aurobindo, which also specializes in unbranded drugs, has 139 patents in the U.S. and the European Union.
Evidently sensing something in the works, shares in Aurobindo have taken off lately, almost doubling since mid-2006.
The Times could not obtain comments from any of the companies.
TARO
Since I'm a share holder i consider this good news.
http://www.globes.co.il/serveen/globes/docview.asp?did=1000179998&fid=942
Encouraging results for Taro’s 1st ethical treatment
T2000 is being developed for non-Parkinson’s involuntary tremors.
Roy Meltzer Gali Weinreb 5 Feb 07 19:25
Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF.PK) is getting closer to becoming a manufacturer of ethical drugs. The company, which is at a crossroads regarding its future, has had a paper "Treatment of essential tremor with the barbiturate T2000" posted to the website of Movement Disorders, the journal of the Movement Disorders Society, prior to its appearance in the print version of that publication.
Taro began Phase II clinical trials of T2000 just over six months ago, also announced that US Patent and Trademark Office has issued a patent to Taro for the use of the company's proprietary, non-sedating barbiturate compounds in the treatment of essential tremor and Parkinson's disease. The patent will expire in June 2025.
The present trials are for two dosages of the drug. The group of 12 patients that received the higher 400 milligram dosage showed significant improvement compared with the control group that received a placebo. The group of 12 patients that received the lower 300 milligram dosage showed no significant improvement compared with the control group that received a placebo. Although the results are positive, the sample was small. “The study shows the need for more trials to assess T2000 as a treatment option for this disorder,” said Taro chairman Barry Levitt. The trial is scheduled to end in August 2007, when the results of a larger trial will be obtained.
Taro originally developed T2000 as a treatment for Parkinson’s disease, but before targeting this large, complex and competitive market, the company decided to target the drug on a similar, less common disorder, where competition is less, and where regulatory procedures might be quicker. Non-Parkinson’s involuntary tremors affect six million people a year in the US.
There are currently four treatments for this disorder, but the best clinical results show a 50% decline in the tremors’ strength. To successfully market T2000, Taro will have to demonstrate in Phase III clinical trials that the drug is not only more effective than a placebo, but also more effective than competing treatments.
Taro added that T2000 is the only treatment without a sedative, which gives the company an additional marketing edge, if and when the product is approved for use.
Published by Globes [online], Israel business news - www.globes.co.il - on February 5, 2007
One more clinical trial for AMD using RNAi
SR Pharma Plc Announces Start of Phase I Trial With Novel RNAi Therapeutic RTP-801i in Age-Related Macular Degeneration (AMD)
Mon Feb 5 01:03:06 2007 (SR Pharma plc)
LONDON, February 5 /PRNewswire-FirstCall/ -- SR Pharma plc (London LSE: SPA) today announces that Quark Biotech Inc. has started a Phase I clinical trial with RTP-801i, a small interfering RNA (siRNA) therapeutic product licensed from Atugen AG, a subsidiary of SR Pharma plc. RTP-801i is based on Atugen's proprietary siRNA (AtuRNAi) technology and modifies the expression or function of one specific gene target, which is involved in the progression of Age-related Macular Degeneration (AMD). RTP-801i has been licensed to Quark Biotech for the treatment of AMD and other diseases. This Phase I study is being funded by Pfizer Inc., which in-licensed RTP-801i in a deal announced on 26 September 2006 for the treatment of AMD.
AMD is the leading cause of blindness in the developed world affecting about 15 million Americans alone over the age of 50. The target indication for RTP-801i is the neovascular or wet AMD. Wet AMD is the most devastating form of the disease and occurs due to the formation of an abnormal vascular network beneath the retina of the eye. These blood vessels are excessively leaky and lead to an accumulation of fluid and blood beneath and within the retina resulting in a loss of visual acuity.
Iain Ross, Chairman, said: "We are excited about the AMD clinical trial commencing as it marks the first clinical study with one of our AtuRNAi molecules. The advancement of this compound represents another strong validation for SR Pharma's proprietary AtuRNAi (siRNA) technology and triggers a further $1.5 million milestone payment. This follows the initial $2 million milestone received in 2006. The fact that this is only the fourth clinical programme with siRNA therapeutics worldwide confirms SR Pharma's leading position in this young Nobel Prize winning technology."
Dr Klaus Giese, Chief Scientific Officer, said "These developments further demonstrate our ability to design siRNA molecules, based on our own patented siRNA chemistry, which can address specific disease targets. This capability means that we are able to generate new molecules for our own development programmes in the cancer field whilst concurrently offering collaboration partners access to stabilised siRNA molecules for use against other targets and indications."
Perhaps because the baker brothers who are 10% owners just bought heavily.
Are there any insomniacs in the crowd?
Published online: 28 January 2007; | doi:10.1038/news070122-13
http://www.nature.com/news/2007/070122/full/070122-13.html
One sleep disorder throws light on another
Treatment based on narcolepsy could promote sleep in insomniacs.
Heidi Ledford
Drug companies compete hotly to make the next big sleeping pill.
Punchstock
By learning from patients who nod off unexpectedly during the day, researchers have pinpointed a chemical that could help people who can't sleep at night.
One out of every 10 people in the United States suffers from chronic insomnia, making for a big sleeping-pill market. The most popular pills work by strengthening the effects of a brain chemical that slows the nervous system and promotes relaxation. But these drugs can also carry unpleasant side effects, including memory loss and grogginess the next day. The race for a better sleeping pill is still on.
Now, a new approach targets brain hormones called orexins. Orexins are known to be linked to sleepiness; patients with a sleeping disorder called narcolepsy have low levels of these hormones and are chronically sleepy during the day, sometimes falling asleep on the job or while driving.
The new chemical, known as ACT-078573, blocks the action of orexins. When given to dogs, rats and humans, it decreased alertness in all three species, while shortening the time it took for them to fall asleep. François Jenck, of the Swiss biotech company Actelion Pharmaceuticals in Allschwil, and his colleagues report the findings in the journal Nature Medicine1.
More time needed
Orexins aren't an obvious target for developing new sleeping pills. Narcoleptics suffer not only from sleepiness, but also from sudden loss of muscle tone that, in extreme cases, can cause them to collapse and remain frozen - fully conscious - for minutes at a time. Laughter often triggers a collapse in human narcoleptics, whereas narcoleptic dogs can crumple from the thrill of dinnertime or being let loose to play in the yard. "They get excited and run out the door and just go 'thump'," says Jerome Siegel, a sleep researcher at the University of California, Los Angeles.
But the new drug seems to bring none of these side effects, says Jenck. People taking the drug reported no loss of muscle tone or lack of coordination — or hallucinations, another common problem for narcoleptics while falling asleep or awakening.
Other experts are quick to caution that the tests are preliminary, and that the drug must be tested over much longer periods of time to be sure it is safe and effective.
Seiji Nishino, a sleep researcher at Stanford University in California, notes that the data come from a single drug dose given to 42 healthy males with no history of sleep disorders. Most insomniacs, he says, suffer chronically abnormal sleep and would need long-term treatment. And although the compound made patients sleepy during the day when orexin levels are high, it remains to be seen whether it will have the same effect at night, when orexin levels are already naturally low. Jenck says that Actelion is currently testing the drug over the long-term in insomniacs.
Nishino also points out that patients diagnosed with narcolepsy often don't experience abrupt loss in muscle tone until six months to a year after they began to experience daytime drowsiness. That means it's possible that the effects on muscle tone won't show up until the brain has been starved of orexins for some period of time, he says.
Meanwhile, orexins have also been implicated in regulating appetite and feelings of reward. So the new drug could potentially have additional side effects — or applications — for weight maintenance and drug addiction. "If we consider these other functions of orexin," says Nishino, "there are likely to be other important uses for the compound."
This fix to the ‘authorized generics’ law will be good news to TEVA as well. See Dews post:
http://www.investorshub.com/boards/read_msg.asp?message_id=16682301
More good reports on TEVA:
I got the IBI report (can not post as it is written in Hebrew, nor attach as i don't have your email) but it was positive and today Citygroup were also very positive with price target of $46.
One has to see the data to offer an opinion, but if I may, glutamate needs to be removed QUICKLY to prevent brain damage and if this method needs to activate an enzyme, build it up to do the job, then it may clear glutamate but the damage was already done.
Am Tech: Teva raised
price of Copaxone
Goldman Sachs also upgraded its rating for Teva. The price hike could give Teva $75m in revenue and $20m in profit on a yearly basis.
Roy Meltzer and Gil Shlomo 18 Jan 07 14:21
US investment house Am Tech estimates that Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) raised the price of its blockbuster drug Copaxone by 9.9% at the beginning of the first quarter of 2007.
According to estimates, Teva's sales of Copaxone last year totalled $750 million, with a 30% profit margin, so the price rise could give Teva an extra $75 million in revenue and an extra $20 million in profit on a yearly basis.
Am Tech stated that the move could give Teva an extra security cushion to help it reach its growth targets for 2007. It left its target price for Teva at $46, a premium of 40% over current market prices.
Also today, Goldman Sachs upgraded its recommendation for Teva to “Buy” from “Neutral”, and raised its target price to $41 per share.
The investment bank believes that the publication of Teva’s financial report in February will probably ease investors’ worries about the company. It also predicts that it will grow rapidly in 2008.
Mergers and acquisitions will probably be Teva’s future growth engines. The company has been mentioned lately as a potential buyer of Merck KGaA’s (XETRA: MRK) generic division for $5.3 billion.
Published by Globes [online], Israel business news - www.globes.co.il - on January 18, 2007
Not a problem at all.
genisi
No, SecForm4.Com is a real-time insider trading data monitoring FREE service but you need to register.
I use this one
http://www.secform4.com/
You can have your own watch list and get email alerts.
AGIX
I don't know what went on at the JPM show but the stock is moving 7% up.
I'm waiting to see the bid. Not going to open the champagne before the deal is done
SGEN
SGN-40 and Rituxan appear to be synergistic in NHL models.
They will test it in aggressive NHL as a single-agent, in combo with R-ICE in 2nd-line, in combo with Rituxan in 3rd-line, and in combo with R-CHOP in 1st-line. SGEN also plans to conduct a combo Revlimid/SGN-40 study in MM.
SGEN (one of my holdings)
I think it is not bad for the company cash flow:
Genentech and Seattle Genetics Announce Exclusive Global Licensing Agreement for Development and Commercialization of SGN-40
Jan 8.--(BUSINESS WIRE)--Genentech (NYSE: DNA - News) and Seattle Genetics, Inc. (Nasdaq: SGEN - News) today announced that they have entered into an exclusive worldwide license agreement for the development and commercialization of SGN-40. SGN-40 is a humanized monoclonal antibody currently in Phase I and Phase II clinical trials for multiple myeloma, chronic lymphocytic leukemia and non-Hodgkin's lymphoma.
Under the terms of the agreement, Seattle Genetics will receive an upfront payment of $60 million, potential milestone payments exceeding $800 million and escalating double-digit royalties on annual net sales of SGN-40. The milestone payments, which are dependent upon clinical and regulatory events across multiple disease indications worldwide, as well as attainment of certain annual net sales levels, include $20 million in committed payments during the first two years of the agreement. Genentech will fund future research, development, manufacturing and commercialization costs. Seattle Genetics will continue certain Phase I and Phase II clinical trials and development activities, the costs of which will be reimbursed by Genentech. Seattle Genetics also has an option for co-promotion rights on SGN-40 in the U.S. The completion of the agreement may be subject to Hart-Scott-Rodino approval under United States antitrust laws and customary closing conditions.
"We are very interested in the encouraging activity of SGN-40 observed in early clinical trials and we look forward to developing this antibody with Seattle Genetics, in addition to continuing our ongoing collaboration on antibody-drug conjugates," said Hal Barron, M.D., senior vice president, Development and chief medical officer for Genentech. "SGN-40 supports our commitment to developing new hematology therapeutics that may provide novel treatment approaches for a variety of serious hematologic diseases."
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070108:MTFH85415_2...
>The top ten pharmaceutical companies invest about 14% of their profits in R&D (Research and Development). However, about 35% is spent on marketing.<
So what are the more realistic figures? (that might turn into a quiz).
This kind of talks lifted TEVA this morning in Tei-Aviv by almost 4%.
I can understand her frustration, i did not touch TARO until it went below $10.
Blade, i can not PM you nor email you so i'll post here and Dew may del later:
Debka has a higher rate of false than true reports and in any case they relay on gossip and speculations mostly. People from outside especially Israelis who live abroad tend to take then more seriously than us Israelis who live in the holyland. I would be more worried from a piece published in the Sunday's Times regarding Israel intention to eliminate Iran's nuclear reactor by nuc bombs.
may the force be with you
genisi
Roger that, thanks.
...and man your are fast!
BR, genisi
AGIX up 27% now!
Two large buyers from insiders
http://www.secform4.com/insider-trading/904973.htm