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I see you are well versed in sophomore debating skills. If you can't respond in substance attack the man.
You can not refute what I said and I couldn't care less what you think of me. The FDA's Colman committed a first-year med student error by combining malignant and benign tumors and then claiming there was cancer risk at all doses. WHAT? I don't know whether he's incompetent or corrupt, although my inclination is to think he fits the second description.
Then, if he was planning to bring up this misrepresented risk why was the panel stacked with unqualified people wrt that issue. It can not be accidental that the main thrust of Colman's attack fell on people who were not ready to evaluate its merit.
The company also never disclosed the rats' names, their birthdays, the precise times of their dosing, how many relatives they had the trials, or any of several million other trial details not considered material. Please read my previous post for why rat cancer was a non-issue.
The rat cancers occurred in statistically significant numbers only at an extremely high dose, higher than the FDA's safety margin of 25x. They should not have been a concern and the company stated that they and the FDA considered the rat tumors not a concern for humans. The benign mammary tumors the female rate grew at elevated doses are normal for rats. They get benign mammary tumors from too much water. They are highly sensitive to changes in their bodies and grow tumors from any disturbance. The mechanism is generally considered not translating to humans.
So nobody missed anything. The FDA torpedoed the panel discussion with a non-issue by combining benign and cancerous tumor numbers and only then getting numbers that were statistically significant, and to ensure that the torpedo would explode they stacked the panel with NO EXPERTS who could speak to the rat cancer non-issue with scientific credentials.
Great analogy. The unqualified panel voting on substance out of its purview and the unplumber who doesn't make any money complaining about taxes on the rich, two caricatures.
What I find more curious is how Audit Integrity, using their forensic accounting model which they claim to be 72% accurate at predicting bankruptcy up to two years before the event by signaling "aggressive accounting," has Arena rated at 27, where low is bad and high is good! What? Arena is a bio R&D about to jump to being an adult pharma co, and I have never once heard any objection to their accounting methods. This looks like short crap to me.
As further evidence of the suspect nature of this list, Sequenom is ranked 8! Again, after a long past accounting scandal and the not yet forgotten T21 scandal that company has something to prove, but after the management housecleaning and obvious progress in the past year I don't see how they can be predicted to fail looking forward and I have heard no objection to their accounting methods since then.
What both companies share is a very large and angry short interest and a lot of analysts supporting the shorts with amazing timing of their hit pieces. A lot of the shorts seem to be funds that lost heavily in earlier bets on these companies and now their investment strategy seems to be driven by a need for revenge and vindication. That is, revenge gets their money back and if they can contribute to squeezing their enemies into failure by any yellow method then they are proven right in calling the companies losers.
I have utter contempt for the pump and dump scamsters that mostly use newsletters to snare less sophisticated investors, and I think these frauds should all be in prison, but I favor public evisceration for the short-selling fraud industry. I do not suggest that all shorts are frauds any more than all longs are frauds, just that the majority of major short players seem to have media in their pockets and use it effectively as a weapon, truth be damned. Media sometimes does a great service exposing genuine scams that should collapse, but I see mostly weaponized reporting and very little genuine investigative reporting.
Why post news that's three business days (Wed morning to Fri evening) old? That kind of announcement has an effective life of no more than a day or two.
"Please correct me if I am wrong"
Ok, you are wrong, but I trust you would prefer to be wrong. The not-yet-completed BloomDM trial will have no bearing whatsoever on the panel discussion and vote. There is no such gorilla and that's just another FUD card tossed in by the bashers who are desperate to slow this train by any means, facts be damned.
The lorcaserin NDA is complete and missing no data. It is a lengthy presentation (3 million pages) detailing the extensive trials that tested the drug for an obesity indication on over 8000 patients, many over two years a,d all with extensive safety monitoring, and with a well-controlled placebo arm and well-controlled diet and exercise counseling.
What was not a part of the trials was a diabetes indication. Jack Lief has stated on several occasions that the diabetes indication would be part of a supplemental drug application later, following approval of lorcaserin as a single-agent obesity drug with improved risk biomarkers. It would be completely out of place for a panel discussion to wonder what indications might be taken up later. The issue at hand will be the safety and efficacy of lorcaserin for an obesity indication.
I have watched many a slam down on biotech plays and quite familiar with the averages when it comes to binary events. And I have a habit of playing multiple option positions over many months or longer, on a single company, pulling out my cost basis or more before binary events. BUT, while there is no sure thing in biotechland I haven't see as strong a play as ARNA is a long time. The only way they will get a negative vote imo is if a majority of the panel members are selected from or paid off by competing interests.
I hope you do some dd on the other stocks about which you might have an opinion, because you seem to have done less than none about lorcaserin and the FDA guidelines for obesity drugs. There are two benchmarks the FDA has established, with an EITHER qualifier, for an obesity drug application. Lorcaserin beat one of these and is therefore fully qualified on the efficacy front. And it's not just 'more safe" (your grudging concession) than Qnexa, it is essentially as safe as placebo with over 8000 patients tested, half of them over two years, and all with extensive safety analysis over the course of the trials.
I hope you were fudging with your position disclosure and that you are in fact short up to the hilt waiting for your $3 bonanza.
Right, and all that verbiage seems intended to state that there were no insidious motives, no omissions, no disagreements, no restatements coming, and that it was just a change of public accountants and the appropriate disclosure filing.
"The FDA can decide it wants a REMS plan at any time up to the final decision on the NDA."
I agree, but to date there hasn't been a safety signal about which to build a REMS program. The company has stated that it has discussed the matter on multiple occasions with the FDA and will prepare whatever educational materials are required. They can certainly remain alert to any issue that could arise, but a more specific program is difficult to visualize when the safety profile has been pretty pretty much an overlay to placebo.
That would be available from the same pusher who is selling GHB. The faux-lorcaserin will be in yellow bags with a blue L on both sides and will be marketed on the street as Nomofat, The GHB-ubetcha will be in 55 gallon drums and marketed as Knockyerselfout. Be sure to watch out for DEA surveillance cameras.
The first mention I know of was during the Q3 o9 Earnings CC:
http://seekingalpha.com/article/172573-arena-pharmaceuticals-inc-q3-2009-earnings-call-transcript?part=qanda
"Craig Gordon - Cohen & Co.
A couple questions, in the NDA Submission, do you guys plan on submitting proposals both for Phase IV commitments as well as a REMS program?
Bill Shanahan
We specifically discussed this issue with the FDA at our pre-NDA meeting and this will be a review issue, but at the present time we don’t see a safety signal to pursue, so we are going to continue to down evaluate our data filed with the NDA and then have discussions with the FDA after that."
Then in the q2 10 call the question and answer were both more specific. I can't locate a free transcript but if you listen to the webcast about 75% of the way in there is a good discussion about REMS and educational materials. http://www.shareholder.com/visitors/event/build2/mediapresentation.cfm?companyid=ARNA&mediaid=42978&mediauserid=4676807&TID=794935353:085ae12801c9b09268074ca763fc5852&popupcheck=0&shexp=201008260108&shkey=4d89e83e26320046479a86f5a1daf71f&player=1
MATTHEW HERPER is a tool, in my not very humble opinion.
1. Qnexa'a panel rejected it soundly because of the known risk factors of the component drugs, each dangerous in its own right. Vivus had put forth a nebulous premise that two two components somehow [magically?] mitigated each other's negatives. No science was put forth to support this strange argument and no REMS was going to be sufficient to overcome the known risks associated with topiramate without broader and longer studies.
2. Fenfluramine was solely responsible, and it has been demmonstrated scientifically, for the valvulopathy effect that took Fen-Phen down. Phentermine has been in limited use for a very very long time and has serious cv risk associated with it, but never has it been associated with valvulopathy. It was not the combination of fenfluramine and phentermine that torpedoed Fen-Phen and Herper has to know that.
3. Lorcaserin revealed no risks during trials that might warrant a REMS, and Arena has publicly stated that they were ready to launch a REMS should the FDA require one but that the FDA had in their many discussions advised that it would not be required.
4. Lorcaserin is a single agent, not a combo agent. The FDA "suggested" to Arena not to trial it with phentermine and Arena followed their advice (publicly stated by Arena CEO). I find preposterous the proposition put forward by some analyst [Wei, another tool imo] that the FDA should now require test data for a combo that will be cautioned against on the label.
Duh! Wamu and the operations indicated by those contact details is the retail banking segment that was taken over by JPM. You did NOT speak to anyone at the holding company.
Trader-B, you might want to consider looking for singles and bunts and not waiting for home runs, most especially with otc stocks but with major exchange stacks as well. Also, set some hard rules about walking away. Do not accept ever-shrinking portfolio values. If 10% is your loss limit then SELL if the share price breaks that. I use 4-6%. NEVER worry about this one or that one getting away without you because that thinking will induce you to break these rules. "The market is an endless stream of opportunities," and if you miss one or lose on one do not look back. Look ahead to the next one.
Looking for singles and not home runs means selling when a run fades, taking whatever profit it gives you, no matter how small. And if it goes the other way you jump off and look for a better horse. I know it's late to do that here, but if you think this one is just a shell game then get out now with whatever you have left and look for a better horse. 25% is more than you might have if this one goes the way of most bb stocks.
I thought CYOE looked compelling too, but baled March 7th after it broke its recent low, selling at $3.10. Even if I thought the story was still good that was a sell signal and I could always buy again if it reversed and started going up on volume. It touched 3.10 only once after that and for the most part just went down down down. In the past I too have held dogs was past their sell signals, but no more. Buy something you can be glad you own without waiting for the pot of gold that rarely if ever comes.
Seems like there's always a reason why the shareholders get screwed here. Does anyone have any hope left that they will file the delinquent report this year, or that they won't earn the third strike by being late again next time? This company is one letdown after another.
I cut my loss on this garbage at .098, except for a worthless little handful stuck in an IRA.
Good science has been damned by incompetent leadership. What a disappointing waste of potential!
That was clearly a bad trade - a typo. The trade should have been busted as they say, and corrected to +1.00. I just used my software to remove the lowest trade and it fell off my chart, so I can't see if it has been reversed/corrected yet.
I don't think insurance is a consideration in the context of that article. It was talking about poor countries. Insurance? Poor people will choose food every time. When medical care may mean a trip to the next town where there is a practitioner of some sort a simple, fast, ultra-low-cost procedure is a working alternative to no care at all. Would local governments in such places fund the nominal cost of such pre-screening. We can only hope they would.
Unfortunately for logic, that is correct. While it goes against logic to skip over zero and have the difference between -1 and +1 be only 1 and not 2, that is what we are stuck with in what is known as the common era.
extracted from http://en.wikipedia.org/wiki/Year_zero
"Third millennium
The 3rd millennium of the Gregorian calendar began on 1 January 2001 (rather than the popularly-celebrated 1 January 2000). This is a direct consequence of the absence of a year zero in the Common Era. Had there been a year zero, which might be considered part of the first millennium, then 1 January 2000 would indeed mark 2000 years since the year numbering datum and be the start of the third millennium."
See also http://en.wikipedia.org/wiki/Common_Era
The Chinese don't bother with that "I'm in my 47th year" stuff. On my wife's 46th birthday she started saying she was 47, and there was nothing I could say to convince her otherwise, common conventions be damned.
But the 21st century still began an 1-1-2000 and the next decade will begin 1-1-2010.
I agree with this poster from the Yahoo MB:
"Re: ACTC News 21-Feb-08 02:03 pm zombietom3
CD's and heavily discounted private placements, which generally include long-term warrants with cheap strike prices are usually the only significant methods that development-stage companies have to raise the money they need to do the R&D it takes to discover something important and useful, and to develop this intellectual property to a stage where it can be sold or partnered for product development. Of course the common shareholders also have a stake in the company and all hope to profit down the road, but they have to bear the pain of continued dilution as these financial instruments are converted to shares and sold. Frequently the share price is depressed as soon as a CD is sold, because the buyers will protect their investment by shorting the company's common. In effect, these large investors have little invested and little risk, since they get their investment back quickly from their short sales. Who really funds the company? The common shareholder, because the large investor takes his money back at the expense of the share price.
Still, common shareholders continue to buy and hold and many will indeed prosper in the end. Many will lose if their patience or time-frame for capital liquidation runs out before the tide rises, or if the tide never rises.
That's the way I see it, as just a common shareholder. "
Yes, it should not be a surprise, and many more such dilutions should not be a surprise. It is the unfortunate burden that all development-stage companies bear, the ongoing need for funding to advance the science and/or get a product to the marketable stage or to set the company up for partnership/merger. The early investor has the advantage of buying at low prices and has to bear the pain of repeated dilutive offerings, CD's, etc.
He said he doesn't like Cytocore, so that gives him the right to trash it. It's not his problem if people expect something that looks like a published article to be even-handed. Somebody was indirectly right when he first posted (on Yahoo board) that the article looks like a lot of short-seller rag articles, timing and content designed to support the shorts, facts be damned or at least be tinted as required for the purpose at hand.
Hi Heels, Would you be willing and so kind as to send a copy of that email to me zombietom3@yahoo.com. If you can I thank you in advance. I use that alias on Yahoo only.
Strange action. I would still be extremely caution before entering a position here, based on liquidity alone, without looking at any fundamental issues. Nevertheless I think today the mm took the bid/ask up just so he could make a buy of 15.5k look like a sell by trading at the bid instead of above the ask, which would have been reasonable considering the absence of volume to support any trades. Or it could have been a limit sell at 2.10 and he wanted the shares enough to walk it up. In either case it looks like the mm is playing a concealing game in a stock with nothing going on at all. Yesterday's news did not impress the market a bit. Results will impress the market.
That sounds like very sound strategy with any stock in a downtrend. Keep an alert set at a price that would only be hit if the share price reverses significantly. If the price continues to erode then you can lower the alert price to remind you to look again when there is a reason. I would also set a volume alert on this one. Right now there is zero interest in this company. In addition to showing the money it needs to show the interest. Right now the lack of liquidity in this stock will turn any position into a lodestone.
To an ordnary investor warrants usually offer much longer time frames before expiration, allowing more time for the share price to exceed the exercise price and bring the instrument (warrant or option) into intrinsic value. This can make warrants less risky, But I can't see much difference in grants of one or the other to company insiders, since grants generally have long time frames in any case.
To your second point, yes, it looks to me too like reduced expectations, or from another viewpoint, the lowered horizon was necessary to keep the insiders on board.
They are light on more than results. How about communications? There is less than zero investment interest in this company. Those in are stuck in and those out see no way in and a bell trap if they do enter. It's a good thing there are no planned sales - who would buy the offfered shares?