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.
mugur...Thank you and I'll certainly keep doing my best for the board.
G' day Mate,
Aussie
Gilead May Gain the Advantage on Its Foes
By Adam Feuerstein
Senior Writer
5/22/2007 11:07 AM EDT
Click here for more stories by Adam Feuerstein
Gilead Sciences' (GILD - Cramer's Take - Stockpickr - Rating) chief scientific officer said Monday that the U.S. Food and Drug Administration might not require regular liver safety monitoring for patients taking ambrisentan, the company's experimental drug for the treatment of pulmonary arterial hypertension, or PAH.
The absence of a so-called "black box label" for ambrisentan would be a huge marketing advantage for Gilead over its competitors, most notably Swiss drugmaker Actelion and U.S. biotech firm Encysive Pharmaceuticals (ENCY - Cramer's Take - Stockpickr - Rating).
The FDA is expected to issue its approval decision for ambrisentan on or before June 18. In an interview Monday, Gilead's Chief Scientific Officer Norbert Bischofberger said the company and regulators are currently negotiating over the language in the ambrisentan label.
Asked if he believed the FDA will require liver monitoring in the ambrisentan label, Bischofberger said, "I don't think it should be in there."
While Bischofberger was careful to say that the FDA would make the final call and that labeling discussions are not complete, he noted his belief that safety data collected and presented to regulators to date clearly show that ambrisentan doesn't cause liver toxicity, and in fact, the drug probably ameliorates the problem in patients with pulmonary arterial hypertension.
"This is the most important data point for clinicians that differentiates our drug [ambrisentan] from the others," said Bischofberger.
How Competitors Stack Up
At present, the approved FDA label for Actelion's Tracleer is topped by a strong warning about the drug's potential to cause serious liver damage. For that reason, Tracleer patients are required to undergo monthly monitoring for liver toxicity. Actelion reported 2006 worldwide Tracleer sales of $730 million in 2006. First-quarter sales topped $210 million, putting the drug on an $800 million sales run rate for the current year.
Encysive's Thelin has shown fewer propensities for liver toxicity, but the risk is still great enough that a warning against liver damage is widely expected in the drug's label. The FDA is expected to issue an approval decision on Thelin by June 15 at the latest.
Data from Gilead's ambrisentan have shown the drug to have essentially no negative effect on liver function. If Gilead can introduce ambrisentan into the PAH market with comparable efficacy and a markedly better safety profile, it should be able to capture a large segment of Tracleer's sales.
But to date, most analysts who cover Gilead still expect the FDA to include language about the potential for liver damage in the ambrisentan label, mainly because the toxicity is thought to be an effect for the entire class of drugs known as endothelin receptor antagonists. The overall market for these drugs is expected to expand to about $1 billion annually, with the introduction of ambrisentan and Thelin.
So far, ambrisentan appears to have the advantage when it comes to liver safety. Long-term follow-up data from 383 PAH patients enrolled in two phase III ambrisentan studies were presented Monday at the annual meeting of the American Thoracic Society.
After a mean exposure to the drug of 1.4 years, just 2.1% of ambrisentan patients developed elevated liver enzymes greater than three times the upper limit of normal. This is the standard measurement for potential liver damage. Only one ambrisentan patient in the long-term follow-up study had to stop taking the drug because of elevated liver enzymes.
By comparison, 2.3% of PAH patients on placebo during the 12 weeks of the phase III ambrisentan studies reported elevated liver enzymes greater than three times the upper limit of normal.
Actelion's Tracleer has a reported elevated liver enzyme rate of about 14%, with about 9% of patients forced to stop taking the drug because of liver toxicity. For Encysive's Thelin, about 6% of patients report elevated liver enzymes, which forces about half that many to discontinue the drug.
In a separate data presentation Monday at the American Thoracic Society, researchers reported that patients who stop taking Tracleer or Thelin because of liver toxicity can be switched to ambrisentan successfully and without any further incidence of liver damage.
Treatment Options
Pulmonary arterial hypertension is a chronic disease caused by constriction of the blood vessels that bring blood from the heart to the lungs. The resulting high blood pressure in these vessels leads to shortness of breath and heart damage. Ultimately, PAH patients die of heart failure. The disease affects about 200,000 patients worldwide.
PAH is treated with various classes of drugs, depending on the severity of the disease. A relatively new trend in PAH treatment is the use of combinations of drugs for greater efficacy.
Once ambrisentan is approved, Bischofberger said, Gilead will move aggressively to develop various combination therapies. Essentially, the company wants to develop a clinical strategy for PAH that mimics the strategy it used to become a powerhouse in the HIV market, he said.
One of the first steps in that direction will likely be work to combine ambrisentan with tadalafil, a PAH drug being developed by Eli Lilly (LLY - Cramer's Take - Stockpickr - Rating). Tadalafil is the active ingredient in the erectile dysfunction drug Cialis. Lilly is seeking to enter the PAH market in exactly the same way that Pfizer (PFE - Cramer's Take - Stockpickr - Rating) did recently with Revatio, a reformulation of its erectile dysfunction drug Viagra.
Tadalafil and ambrisentan are both dosed once a day, so the potential is there for Gilead and Lilly to partner on a fixed-dose, single-pill combination treatment for PAH. This is something that Actelion and Pfizer cannot do because Tracleer is dosed twice per day, while Revatio is dosed three times per day.
"The hardest part will be putting together the business agreement," between Gilead and Lilly, said Bischofberger. "From a clinical perspective, a combination of ambrisentan and tadalafil is fairly straightforward."
Before that happens, Bischofberger believes that ambrisentan will be able to replace Tracleer in patients who are now taking a combination of Tracleer and Revatio. Bischofberger believes doctors will be inclined to make this switch because Tracleer decreases the efficacy of Revatio, while ambrisentan does not.
Gilead shares closed Monday down 32 cents to $82.70.
-------------
g' day Mates,
Aussie
Mugur...Not that you need another assistant for the board; however, if you want one, I'd be glad to have my name added.
Just a thought.
G' day Mate,
Aussie
Reasons Why Stock Splits Increase Profits For Investors
>> The stock split announcement draws attention to a company's success. This results in increased buying and higher prices.
>> Companies will often report high earnings and raise dividends at the same time they announce a stock split. The synergy of these events can drives the price of the stock up even more.
>> The reduced price per share after companies split a stock attracts many smaller investors.
>> With so many news and information services reporting stock splits, the announcements themselves have become a market-moving force.
Stages Of A Stock Split
Studies at RightLine show that the "typical" life cycle of a splitting stock can be dissected into six major categories:
PRE-ANNOUNCEMENT
* The RightLine Report High potential stock splits in every issue.
Stocks usually enter this stage quietly and without fanfare after a long period of healthy growth. However, in some cases emergence into the Pre-Announcement stage occurs quickly, as a unexpected windfall causes a rapid increase in the stock price. This stage of a stock split is often associated with significant appreciation in share price.. The key to profiting from this stage is being able to determine which stocks are the most likely to split and when.
ANNOUNCEMENT The upbeat atmosphere of a stock split often pulls in a large number of new buyers. This influx of traders and investors can lift the stock price higher, giving exceptional gains for those positioned in the stock prior to the split stock announcement. For those who are not in the stock before the split announcement, this stage usually offers low-risk setups for timing short-term trading entries.
DORMANCY There is generally a return to normal price behavior in the weeks following a split announcement as the initial interest subsides. The shorter the time between the announcement and the split date, the less subdued this stage will be.
PRE-SPLIT RUN For many stocks this is the most powerful phase of the split cycle as investors dramatically bid up the price of the limited supply of shares.
THE SPLIT The day of the stock split provides more investor awareness of the already well publicized stock split. Many investors who watched the stock rise at the announcement and again during the pre-split run will now buy shares at the lower split prices. These final buyers can push prices even higher.
POST-SPLIT After the last buyers are in, investor excitement for the split stock can begin to fade. Prices will often retreat for a while as shares are sold to lock in profits. This stage of a stock split can deliver excellent shorting prospects. While some split stocks will pullback and consolidate for a while, strong performers often dip, quickly rebound and then continue to fly higher.
-------------------
Hope this helps any one who isn't familiar with splits or, those that may need a brush up.
G' day Mates,
Aussie
mugur/verylong...What do you think about this play. GTW Jan08 5 calls at $.05? Gateway has done horrible but everything I read says they could stage a come back of sorts. May not hit their previous status but, it's not unrealistic to think they could go to $5 or a little higher.
Buy 20 calls and all you can lose is $100. Seems like it might be worth the risk.
G' day Mates,
Aussie
Ronnies...Here's the html referred to in the prior post. You have to sign up to listen to it.
http://www.cnbc.com/id/15840232?video=323498863
G' day Mate,
Aussie
Ronnies...Found this on a AVN board that is not posted on too frequently.
By: thor95678
19 May 2007, 05:43 PM EDT
Msg. 35594 of 35595
(This msg. is a reply to 35593 by gd2aussie3.)
Jump to msg. #
News leak????
I found this interesting...
News Leak at Avanir Pharma?
by Thomas C.
May 18, 2007 04:44 PM EDT tags: money, ant and sons
email to a friend print this article
digg it del.icio.us
CNBC biotech/pharma reporter Mike Huckman had an interesting story this morning on how confidential data from pharmaceutical and biotech companies may be hitting the Street before the information is public. He mentioned that leaks are coming from biotech and pharmaceutical conferences. Click here to watch the video.
Shares of biotech and pharma stocks are always on the move, and Avanir Pharma (NASDAQ: AVNR) which is currently focused on the late-stage clinical development of drug candidate Zenvia, is no exception. The company recently reported top-line results of a Phase III study for Zenvia in diabetic peripheral neuropathic pain (DPN) where the primary endpoint was met. These data have been accepted for presentation at the International Congress on Neuropathic Pain in Berlin on June 8, 2007. Avanir has also requested a meeting with the U.S. Food and Drug Administration to discuss the next study for Zenvia for the treatment of DPN pain.
But after watching the video and witnessing today's run up as result of no significant publicly available news, it makes you have to wonder why the stock is substantially higher and trading so actively. Avanir shares are finishing the day higher by $.38, or11.91%, to$3.57 on very heavy trading of 12.2 million shares, more than double the daily average volume of 5.4 million shares. The stock has tacked on nearly 27% in the past two sessions.
------------------
G' day Mate,
Aussie
Ronnies...I had GILD and did good on it. Currently have some options of it. They are, as you know, also up for FDA approval with ENCY. GILD being the better established company and more used to fighting with the FDA has a slight edge in the process. However, to me it doesn't matter. If ENCY gets approval and GILD has a head start, there is more than enough room for the both of them to make millions. It's that fact that makes ENCY an attractive buy. ENCY I also have options on.
Right now, since the no earnings news on the 8th of this month by ENCY, it has been a little weak. Its 7 & 18 day SMAs are slightly below its 30 day SMA, which is not bad. If they were heading in a straight downward direction, that would be bad.
I not only have AVNR, but also PRX.
G' day Mate,
Aussie
Here was a good call but, I might have pulled the trigger a little too quick. NOK Jul30 calls I bought at $.05. Sold today at $.20.
G' day Mates,
Aussie
G' day ronnies! AVNR lately has been exactly that -- one funny acting stock. No information out there I could find to say otherwise. If anything is found, believe me, the members get it and post it on one board or another and then we post it.
G' day Mate,
Aussie
FMX up $2.63 so far today.
G' day Mates,
Aussie
FMX forward split of three-for-one -- will take place on May 30, 2007, to holders of record as of May 25, 2007. could be a good options play. Also, note the quick timing for this. Not much time for the stock to go on a dip as splits tend to do right before the split. Then after the split they up a bit.
G' day Mate,
Aussie
DoubleK...A bit sensitive over a little humor aren't you? No need to try insults. No offense was intended to you. If it was taken, then I apologize.
G' day Mate,
Aussie
DoubleK...Yes it was and, look what it has flourished into today. Know a little of your Aussie history - g' show. Australia however is well respected and a very peaceful, loving country.
Avnr is down a tad right now. Needs a bit a news to perk it up some.
G' day Mate,
Aussie
LOL. Looks like CI is playing the same game today. It has been up as much as $1.99 this morning. End of the day should prove interesting.
G' day Mates,
Aussie
DoubleK...You mean Zenvia™ for IEED right? Or, do you know about a new product for Avanir? LOL.
G' day Mate,
Aussie
Karizmat...Hope you're right. Unfortunately, I don't see anything out there that points along those lines.
G' day Mate,
Aussie
What a wicked turn around for the day so far. CI which I reported earlier was blazing through the morning. Then shareholders ate their lunch and their indigestion took over. The stock so far today has gone from a high of $167.20 to $164.38, where it opened at today. Who knows where it will finish up today. What a market.
G' day Mates,
Aussie
Here seems to be a really good call. Post #142 on 4/25 told of the impending 3-for-1 forward split of CI. At the time, CI was going for about $153.95. Today it has so far reached $166.06. and the split isn't due to occur until June 12th for those shareholders of record as of May 21. Can't wait until the split to see how it does.
G' day Mates,
Aussie
3Saints...No problem. I understand the deletion. You can post any comments in reference to that stock on that board and it will be responded to.
G' day Mate,
Aussie
Avanir is up $.60 and those puts are in danger. What amazes me is Avanir is up on absolutely no news at all.
G' day Mates,
Aussie
May 14 /PRNewswire-FirstCall/ -- Questar Corp.'s (NYSE: STR) board of directors today declared a two-for-one stock split. The stock split will be distributed June 18, 2007, to shareholders of record on June 4, 2007.
AND, they have options.
2-for-1, 3-for-1 and 4-for-1 forward splits of good companies make good call plays.
G' day Mates,
Aussie
Original...Appears I was, as you chaps wanted something extremely simple such as "My WAG June 21, 2007 - 2:00pm Aussie."
So, let that be my WAG.
G' day Mate,
Aussie
Original..Found the post on the wag. It appearded "Date: 5/11/2007 3:21:12 PM" as number 7640.
Now for me to get much needed sleep.
G' nite Mate.
Aussie
Same time. I won't be in Australia until June 14, 2007. I have residency here in the States in New Jersey.
G' day Mate,
Aussie
Original...Yes, thank you. To bad you didn't say that in your first response. I could be sleeping by now. LOL.
G' night Mate,
Aussie
Original...Thank you and I can agree with that only one time slot per poster. I guess if my scenario of the three posters at the precisely the exact same second in time were to post, then each would be given a different time slot, regardless of the one they picked. It just seems mathematically it could happen and it was sort of playing on my min. With Len, I was trying to make sense out of it by imagining three posters picking the exact same time slots at the exact same second. That's what imagination does to one late at night. Time for me to go to bed.
By the way, I checked the time slot I thought I posted the WAG and it's not there, the post does appear on IHUB Posting Milestones (milestone). So, obviously, I did something incorrect. Try again tomorrow.
G' day Mate,
Aussie
Len...Good show.
My scenario thought you could have three people in three different areas do the following posts.
10:05 Mary
10:05 Harry
10:05 Leroy
All three hit the send button at precisely the exact second in time and all were recorded at 10:05. Are you saying this is impossible?
If yes, end of discussion and, I'll just have to accept it. Not believe it though.
G' day Mate,
Aussie
Original...Will do and thanks.
G' day Mate,
Aussie
Len...I read and do understand the rules. It just seems like a possibility the same as your two tie does.
If, as you say, "NO TWO PEOPLE CAN HAVE THE SAME TIMES." then, how is it possible for two way tie.
But, using your scenario, if it is possible for a " two way tie because the exact time to the second COULD happen (theoretically) exactly between any two people.' then, why can it not happen for three?
G' day Mate,
Aussie
Original...I thought I did? Seems I can't find it or, I have lloked in the wrong place for it.
G' day Mate,
Aussie
Len...Which is it? You state it can't happen then, give a scenario where it can happen at the exact same second for two posters. I say if it can happen for two as you say, then it can happen for three as I say or, unimaginable as it seems, for even more. Who knows?
G' day Mate,
Aussie
Usually speaking, a "WAG" is a wild ass guess, so here's mine. There will be a three way tie at the end. The three will have to split the $750 to get $250 apiece, while the next two suspects will also get $250 for being the next two posting closest to the "WAG" time.
G' day, Mates,
Aussie
Mugur...One presumes you're talking about Avnr? How much could you gain in puts by it only dropping fro$2.60 to $2.50.
Personally, I'd leave it alone and start looking for the next call opportunity.
G' day Mate,
Aussie
I'd use the money to buy a membership. :)
G' day Mates,
Aussie
Avanir 2Q Loss Narrows on FazaClo
http://money.aol.com/news/articles/_a/avanir-2q-loss-narrows-on-fazaclo/n20070509103309990027
----------------------------
G' day Mates,
Aussie
What and miss the reports coming from overseas?
DoubleK how do you feel about this post, "OT: DNDN down $10. in premarket...Biotechs can be brutal as
AVNR shareholders know too well....ouch !!"
I believe DNDN is down now by $10.84 to $6.87. Now there's a real ouch. Glad I stayed away from it.
G' day Mate,
Aussie
Griff..there are days I hate being right. But, that's what studying and knowing a company is all about.
G' day Mate,
Aussie
Gilead Approves 2-For-1 Stock Split
AP
FOSTER CITY, Calif. (AP) - Biotech company Gilead Sciences Inc. on Tuesday said its board approved a two-for-one stock split.
Stockholders of record on May 24 will receive a dividend of one additional share for every one they own. Gilead's stock will begin trading at the post-split price on June 25.
----------------------
IMO, this is a good call play as forward splits of a good company usually go up for a couple weeks after the announcement. Then they level off or drop a little. After the split they go up a bit more than level off again and that's when you sell them.
G' day Mates,
Aussie
mugur...What for sale without reading today's quarterly results? It's posted on the AVNR board. Those puts might still be good as it's another losing quarter.
G' day Mate,
Aussie