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Official Adderall XR Timeline 8/2004-12/2009
08.12.2004 US Food & Drug Administration (FDA) approves ADDERALL XR® to treat adults:
http://www.shire.com/shire/NewsAndMe...n=3&m1=8&m2=20 02.22.2005 ADDERALL XR™recall has highlighted a critical problem for Health Canada: http://www.shire.com/shire/NewsAndMe...n=3&m1=8&m2=20 Health Canada appears to have ignored a number of issues or neglected to take them into consideration.. ...The FDA in the United States has had access to the same data but has had a very different interpretation and response to Health Canada. In the confusion over the interpretation of the data and Health Canada's response to it, Canadian parents are left with a suspicion of all medications. Late January through June,Impax and Barr have been filing letters for generic rights. 08.24.2005 Shire Pharmaceuticals announces reinstatement of ADDERALL XR® in Canada: http://www.shire.com/shire/NewsAndMe...n=3&m1=8&m2=20 10.13.2005 Shire submits Citizen Petition with the Food and Drug Administration: http://www.shire.com/shire/NewsAndMe...n=3&m1=8&m2=20 Shire filed a Citizen Petition with the FDA to require more rigorous bioequivalence testing or additional clinical testing for generic or follow-on drug products that reference ADDERALL XR before they can be approved. Compliance with these requested criteria will ensure that generic formulations of ADDERALL XR will be clinically effective and safe. 10.20.2005 Shire Files Legal Suit against Barr Laboratories and Impax Laboratories for Infringement of XR- U.S. Patent No. 6,913,768: http://www.shire.com/shire/NewsAndMe...n=3&m1=8&m2=20 01.19.2006 Shire and Impax settle all pending litigation concerning XR: Nothing changed in the Impax formula,but now Shire isn't worried about the health concerns noted in their petition. It was dropped. Impax will be permitted to market generic versions of ADDERALL XR in the United States no later than January 1, 2010 and will pay Shire a royalty from those sales. In certain situations, such as the launch of another generic version of ADDERALL XR, Impax may be permitted to enter the market as Shire’s authorized generic. No payments to Impax are involved in the settlement agreement. 04.10.2006 ADDERALL XR® The Court Sets October 30, 2006 Bench Trial: http://www.shire.com/shire/NewsAndMe...n=3&m1=8&m2=20 ..pending New York litigation between Shire and Barr Laboratories, Inc. involving alleged infringement of U.S. Patent Nos. 6,322,819 and 6,605,300, the Court in a pretrial conference scheduled the bench trial to commence on October 30, 2006. Note what happens before 10.30.06,below. 04.20.2006 Shire Receives Interim Response From FDA on ADDERALL XR® Citizen Petition: http://www.shire.com/shire/NewsAndMe...n=3&m1=8&m2=20 Bad news for investors. FDA has not yet resolved the issues raised in Shire’s pending ADDERALL XR Citizen Petition. The FDA states that due to the complex issues raised requiring extensive review and analysis by the FDA’s officials, a decision cannot be reached at this time. The FDA’s interim response is in accordance with FDA regulations concerning Citizen Petitions. 08.14.2006 Shire and Barr Settle All Pending Litigation Concerning XR: http://www.shire.com/shire/NewsAndMe...n=3&m1=8&m2=20 Nothing changed in the Barr formula,but now Shire isn't worried about the health concerns noted in their petition. It was dropped. Barr will not be permitted to market a generic version of ADDERALL XR in the United States until April 1, 2009, except for certain limited circumstances, such as the launch of another party’s generic version of ADDERALL XR. As announced earlier this year, Shire’s settlement with Impax Laboratories allows Impax to market a generic version of ADDERALL XR 181 days following Barr’s launch. No payments to Barr are involved in the settlement agreement. They had to settle. The Bench trial was scheduled for Oct 30th...76 days away. Shire kept their patents. Patent #6,913,768 - "Sustained release delivery of amphetamine salts"-2005 http://www.wikipatents.com/6913768.html (Great Charts,BTW) Patent # 6,605,300 "Oral Pulsed Dose Drug Delivery System" -2003 http://www.wikipatents.com/6605300.html Patent #6322819 "Oral Pulsed Dose Drug Delivery System" -2001 http://www.wikipatents.com/6322819.html 11.29.2006 Sandoz files papers to mfg generic XR: (see link to pdf file below) 01.25.07 Shire files against Sandoz for Patent Infringement: http://patentdocs.typepad.com/patent...e_v_sandoz.pdf This is a pdf file of court documents.For some reason,this wasn't released to the shareholders through normal channels. Patents that Shire is defending: (same as above) Patent # 6,322,819 "Oral Pulsed Dose Drug Delivery System" 2001 Patent # 6,605,300 "Oral Pulsed Dose Drug Delivery System" 2003 03.21.2007 Shire Files Suit against Colony Pharmaceuticals for XR patent infringement: http://www.shire.com/shire/NewsAndMe...n=3&m1=8&m2=20 09.03.2007 Stock Price: Hi $81.0000 Vol.1,862,155 06.20.2008 Shire feels heat of impending patent expiration: http://www.smartmoney.com/investing/...r-Shire-23325/ If the FDA opens the gates to XR generics and Vyvanse can't defend the franchise, then Shire wouldn't merit its 25% premium to the 12 times multiple carried by most pharmaceutical stocks. An industry multiple would pull Shire shares down to a level equivalent to about 40 on the depositary shares. Shire executives and admirers think investors are unduly worried about the XR patent expiration. Some 60% of Shire revenues come from other products, notes Mike Cola, president of its specialty pharma business. He's confident that Vyvanse will become the best-seller for ADHD. And Adderall XR could end up thriving beyond next year, if the FDA concurs with Shire's petition and raises testing hurdles for XR generics. 10.27.2008 Stock Price: Hi $40.5300 Vol.5,527,685 http://www.nasdaq.com/aspx/dynamic_c...selected=SHPGY ~04.01.2009 Barr Markets Adderall: From Shire: “We are bottling them and labeling them and shipping them to Teva and Impax respectively, and then they distribute them through their channels through wholesalers and pharmacies,” Cabrey said. “The difference is that it isn’t a true generic because none of the other pharmaceutical companies have gone through the exercise of clinical trials to demonstrate that they can produce the same exact molecule with the same exact efficacy and safety profile as the original.” 10.13.09 Shire and Sandoz Settle All Pending Litigation Concerning ADDERALL XR®: Nothing changed in Sandoz formula,but now Shire isn't worried about the health concerns noted in their petition. It was dropped. http://pharmexec.findpharma.com/phar.../detail/634102 The settlement also gives Sandoz license to market a generic version of Adderall XR if and when FDA approves it. That said the chance that Sandoz would pursue the application with two existing patents in play is doubtful. “Sandoz is welcome to initiate and authorized generic once they get approval from the FDA,” Shire’s Director of Communications Matt Cabrey said. As of right now, there are only two authorized generics approved and available to patients and both are manufactured by Shire—one for Teva and one for IMPAX Labs. “We are bottling them and labeling them and shipping them to Teva and Impax respectively, and then they distribute them through their channels through wholesalers and pharmacies,” Cabrey said. “The difference is that it isn’t a true generic because none of the other pharmaceutical companies have gone through the exercise of clinical trials to demonstrate that they can produce the same exact molecule with the same exact efficacy and safety profile as the original.” Shortly after Adderall XR was approved, five companies challenged Shire’s patent. From an investment perspective Shire was stuck in the notion that if it lost patent that the company would be in dire straits. In 2006, the executive team at Shire agreed to partner with Teva and IMPAX to mitigate concern. “It helped to reassure investors that Shire had a plan in place to position our portfolio of drugs, and we knew we could put into place efforts around commercializing the new ADHD treatment Vivance,” Cabrey said.“That allowed us to concentrate on maximizing our investment in Vivance, which we purchased in 2007.” http://www.shire.com/shire/NewsAndMe...n=3&m1=8&m2=20 Shire, on Tuesday, publically stated that it had come to an agreement with Sandoz to forgo any litigation involving Adderall XR. In exchange, Sandoz admitted it had infringed on two Shire patents. Shire kept its patents. 12.02.09 Shire and Teva Settle Litigation Concerning Supply of ADDERALL XR Authorized Generic: Shire claimed DEA restricted amphetamines,and couldn't supply Teva. http://www.shire.com/shire/NewsAndMe...n=3&m1=8&m2=20 Shire’s ability to supply the product had been limited by restrictions that the US Drug Enforcement Administration (“DEA”) places on amphetamine, which is the product’s active ingredient. Teva filed suit claiming that Shire was in breach of its supply contract. After the lawsuit was filed, DEA granted Shire additional quota for 2009, allowing Shire to supply Teva with additional product. Shire kept its patents. 12.10.09 Sandoz still not FDA approved: The settlement also provides Sandoz with a license to market it own generic versions of ADDERALL XR® in the United States beginning upon approval of its own generic products by the FDA Before 01.01.10 Impax allowed to market XR: Impax will be permitted to market generic versions of ADDERALL XR in the United States no later than January 1, 2010 ++++++++++++++++++++++++++++++++++ Earlier related thread:http://www.addforums.com/forums/showthread.php?t=75190 Shire XR 2007 Ingredients:http://www.fda.gov/downloads/Drugs/D.../ucm085819.pdf
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CptNemo |
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Re: Official Adderall XR Timeline 8/2004-12/2009
Would like to add/update timeline:
10.06.2009 Impax Labs commences shipment of generic Adderall XR capsules: http://www.pharmabiz.com/article/det...994§ionid= =================================== It seems very obvious to me,and a very indisputable conclusion. There is an absolute difference between Brand XR,and every other generic XR. The delivery system is the key difference. Shire maintained its patents on all the delivery systems,and it can be seen that they put those patents above all else,when legal action was taking place,in regards to competing generics. They just threw the safety and mental health of all the patients,out the window.It is clear that money alone is their primary concern. It doesn't surprise me ,really. What drives people like us, is not what drives the financial world,and our plight is of no consequence. The timeline shows that in all its sad glory. Those patents are their most prized possession. They are the key to their Brand's success,and the FDA just wandered around with their fingers up their buttes,and let money decide the fate of health,instead of morals and principals. Mr. President,good luck with your goals for the US health system. Except for the few lines in this color and font,all that info is taken directly from the listed sources next to the text. My goal was to present a chronological list of facts,without clouding them with personal perception,or influence.Well,almost. As you can see,most of the listed sources are Shire itself,pulled from five years of their 'press releases'. What does everyone think? Am I misreading the facts? (I've been known to do that. )PS: I know its long.I tried to make it so a person could just read the bolded lines,and get the gist of it. Not sure if that worked.
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CptNemo |
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#3
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Re: Official Adderall XR Timeline 8/2004-12/2009
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Why do you expect otherwise? Shire's main problem is that their heavy specialization sets them up to take a hit every time they lose a patent. Shire primarily involves itself in ADHD medications and genetic drugs. They don't have a rapid enough or large enough pipeline to replace their exclusive brands quicker than they lose them. Adderall XR has been the best in the market for a long time, and amusingly, Shire is faced with the task of beating its own drug in the market. Regardless, though, the fact of the matter is that Shire is a pharmaceutical company, not a doctor or a clinic. The only obligation it has to patients is to provide quality medications that help people - and the only reason it has that obligation is because that is the vehicle by which the company serves its only real purpose: to return a profit to the shareholders.
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Counting stars by candlelight, all are dim but one is bright: the spiral light of Venus, rising first and shining best, oh, from the Northwest corner of a brand new crescent moon. Crickets and cicadas sing a rare and different tune: Terrapin Station! In the shadow of the moon. Terrapin Station! And I know we'll be there soon. |
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Re: Official Adderall XR Timeline 8/2004-12/2009
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I have gotten the impression though,that many members seem to ignore that fact. Some people have a misplaced trust in their government,which until recently,I did too. Why do you think so many people can't accept that all generics are the same as the originals? Thats what we are told,by the govt(FDA). I also don't expect people to stop stealing credit card information. As you say,they too exist to turn a profit. I am of the opinion that is bad. Not just long term to the financial powers that run our government. Please don't explain to me how theft promotes capitalism by creating a new market for software security companies! I ,whether naively or not,believe that this country has a commitment to its citizens. Liberty is out the window,but I expect our leaders to still maintain the illusion of life,and the pursuit of happiness just a little bit better. ![]() I thought others might feel the same way. The President even told me as much. ![]() I understand the nature of the beast,but I feel the govt should try to stop serial killers,for reasons other than capitalistic concerns. This is closer to my concern: Quote:
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I don't have a solution.Too much red tape,and I have no idea how to fix the situation. My biggest concern,is public awareness of this situation. As I smoke my cigarette,I am not as concerned about the whole 'killing me' thing,but I would be pretty pi$$ed if I wasn't made aware of a health concern regarding it. Obviously I don't care enough about myself,but I do for others. The public never would never have been made aware of this,if the govt didn't step in. I'd like them to do it again,please. Life is not 'fair'. I get that. Even with this knowledge,I can't afford the best. The generics are much better than going without. I concede. I'm glad I have that option,that many don't. If I had a kid with adhd though,and knew what I do now,I would sure as he^^ sell my Plasma to get him another 6 months of the best meds,if he wasn't responding well to a generic I knew was different. Quote:
Luckily for them,they found the best solution to their problem. 01.01.2010: Original Shire formulas for IR and XR to disappear forever: http://www.prescriptiondrug-info.com...002541&ad=true Quote:
They leveraged themselves legally,formed an agreement with competitors,and are getting large royalties to take what is arguably the best medicine in the history of ADHD,and bury it forever. As you say,they need to turn a profit.I agree. Seems the govt should give them some more options,that's all.
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Re: Official Adderall XR Timeline 8/2004-12/2009
Did you seriously compare the profitability of a publicly traded company to credit card theft and serial murder just then? I don't even see how that makes sense.
I don't see how the government factors into this at all, except as red tape which keeps companies from being as profitable as they could be (for better or for worse, this is necessary to ensure companies behave ethically). I don't see how the Hatch-Waxman Act is relevant here except as a process that the generic manufacturers have to go through. Pharmaceutical companies behave pseudo-altruistically all the time, by providing drugs at reduced costs to people with limited incomes (with the return of future sales and improved public image). They do help consumers, and they do provide a service in developing the future of medical care. But those aren't their purpose: their purpose is to make the investors happy.
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Counting stars by candlelight, all are dim but one is bright: the spiral light of Venus, rising first and shining best, oh, from the Northwest corner of a brand new crescent moon. Crickets and cicadas sing a rare and different tune: Terrapin Station! In the shadow of the moon. Terrapin Station! And I know we'll be there soon. |
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Re: Official Adderall XR Timeline 8/2004-12/2009
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I feel those two analogies you can't make sense of are examples of why the govt needs to take responsibility for the general public. I.E. Laws. Those two examples are entities,yet they share actions that may benefit themselves,but not the public as a whole. I'm not sure if you disagree with my view,or my analogies. I notice you didn't use my tobacco companies analogy. If you prefer an apples to apples comparison,just use the one with tobacco companies. Do you feel 'big tobacco' should be left unregulated? There is some pretty damning science based evidence that their product might not be good for people. The FDA stepped in. If you think that's wrong,you should let them know. Quote:
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![]() I'm just expressing my opinion,which is that I just don't think either of those purposes should be held in the same regard by the govt.
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Re: Official Adderall XR Timeline 8/2004-12/2009
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But in fact this is not an apples to apples comparison. A better comparison would be some other form of patented product. The pharmaceutical industry is the only industry where market exclusivity is lost. Coca Cola will always be allowed to keep their exact recipe a secret. The seven herbs and spices will forever be a trade secret. Pharmaceutical companies have a very narrow window to make enough returns to make the drug profitable after R&D costs. These companies spend millions of dollars just developing the drug, then marketing and manufacturing, there is a lot of overhead that goes into pharmaceuticals. Can you blame a company for trying to turn a profit on its intellectual property? Should musicians lose the rights to their music 10 years after they perform it? If companies are not free to make a profit on their products, then there is no incentive to develop new products. If a drug company is not allowed to profit from its drug, then why would they continue to spend millions, or in the case of companies like Pfizer, billions of dollars researching? Surely you don't believe companies should be compelled to behave altruistically? Quote:
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Counting stars by candlelight, all are dim but one is bright: the spiral light of Venus, rising first and shining best, oh, from the Northwest corner of a brand new crescent moon. Crickets and cicadas sing a rare and different tune: Terrapin Station! In the shadow of the moon. Terrapin Station! And I know we'll be there soon. |
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Re: Official Adderall XR Timeline 8/2004-12/2009
Those are very interesting points.
Frankly,I really don't know to respond. ![]() Quote:
I almost feel guilty,but: I can recommend a book for you. "The Jungle",by Upton Sinclair. 1905 He's the socialist that started this whole mess. He,and people like him,have tainted my views. ![]()
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CptNemo |
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Re: Official Adderall XR Timeline 8/2004-12/2009
I'm familiar with The Jungle. It was extremely relevant in the early 1900s.
I would like to recommend a book of my own. You may have heard of it, it's called The Wealth of Nations. Quote:
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Where would we be without them? But they are in the end corporations whose purpose is to return a profit to their shareholders. You can criticize them for looking out for their own self interest, but I feel it's untoward to place a higher moral standard on pharmaceutical companies than on other companies solely because of the market they are in. Nobody demands General Motors provide free cars, or KFC to provide free meals, but yet people deride pharmaceutical companies for charging so much for their drugs or doing things to remain profitable in what is ultimately a hostile marketplace. Shire has every right to look out for its patents, and in fact it benefits their shareholders to do so. It would be a delinquent company if it did not - there would be no investor confidence. Publicly traded corporations exist due to their shareholders: sale of stock is how they raise the capital necessary to operate. If Shire did not protect its patents, nobody would want to invest in Shire, Shire's value would plummet, and Shire would no longer be able to operate. Edit: And with Shire unable to operate, the research into future ADHD drugs (and genetic drugs - Shire has specialized but diverse interests) is lost, and current medications like Vyvanse can't be distributed. In this way, in fact, it is beneficial to everyone for Shire to protect its patents and remain profitable.
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Counting stars by candlelight, all are dim but one is bright: the spiral light of Venus, rising first and shining best, oh, from the Northwest corner of a brand new crescent moon. Crickets and cicadas sing a rare and different tune: Terrapin Station! In the shadow of the moon. Terrapin Station! And I know we'll be there soon. Last edited by KMiller; 12-12-09 at 01:36 AM.. |
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Re: Official Adderall XR Timeline 8/2004-12/2009
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I even went as far as to add "(good)" and "(bad)" to one of those statements,to be sure you understood. Its ironic(again ) that you suggest that you want to stay "vaguely on topic",when you seem to be unclear of what the topic is.Yes,that book by the socialist Upton Sinclair *was* important to people in the early 1900's. It ultimately led to the FDA. The FDA was established to keep the public safe from negative consequences resulting from capitalism. Do you think Enron should have just had the 'invisible hand' lead them,instead of the govt? Same with tobacco companies? To use your style of argument: Do you hate all babies,or just American babies? ![]()
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CptNemo |
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Re: Official Adderall XR Timeline 8/2004-12/2009
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Also, I've missed key parts of points. I apologize, I've been working 40 hours as well as taking two courses this week, my brain is cooked. What led me to the impression that you were arguing that it was bad that these companies are doing these things were lines like Quote:
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And actually, I made it clear that I didn't understand why you brought it up or what you were on about. Quote:
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Edit: like, legitimately angry. I know I don't use fallacy in argument, do I come across like I do somehow? I could see how you could think I've been attacking a straw man, but I legitimately have not apprehended the point you're trying to make.
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Counting stars by candlelight, all are dim but one is bright: the spiral light of Venus, rising first and shining best, oh, from the Northwest corner of a brand new crescent moon. Crickets and cicadas sing a rare and different tune: Terrapin Station! In the shadow of the moon. Terrapin Station! And I know we'll be there soon. |
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Re: Official Adderall XR Timeline 8/2004-12/2009
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You did me a service,by getting me away from my ethical stance,regarding corporations. I can't comprehend how the decision makers of big business can live with their conscience sometimes. I stated my feelings on that,and it clouded my more important point: I think the govt needs to change/create laws that allow the corps to thrive in a more ethical manner. I realize how my naivety has nothing to do with their true goals,as you have pointed out. I would never succeed in this environment,obviously. I don't think you would,either. I mean that as a compliment. I'm sure you could use your brainpower to create a lot more wealth for yourself than your current direction is leading you. I can't help but think/hope that we are similar in our motivating factors. Quote:
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To that,I suggest their decisions not only negatively impacted the greater whole of capitalism,but perhaps themselves. I will leave morality out of it do to relevance here,to Enron's concerns. I feel that exposing their methods,and the need to create new laws based from this experience,is an important necessity of our govt. Furthermore,I would suggest that the govt needs to interject not only for economic concerns,but moral ones as well. I feel this is their duty. Perhaps the degree of importance of morals;or perhaps the fact that the govts motives are really never as altruistic as they appear,or abused,are your complaints about their intervention. Maybe the extent,or mishandling of their influence is bad. Quote:
I am suggesting that the discovery of 'Big Tobacco' willfully hiding proof of the highly addictive nature of nicotine is morally wrong. Health concerns being acknowledged by the Attorney General is necessary for public safety,and trumps capitalistic concerns. Advertising aimed at children,for a product known to be highly addictive and carcinogenic,should be banned for similar reasons. I am not debating whether govt influence is not overzealous or misdirected,nor suggesting that cigarettes be made illegal. Quote:
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Actually,I thought it was an amusing conclusion,and thought that was your intent. ![]() That's why I put the symbol in that baby statement.Please take no offense. I have no doubt that you like babies and have high moral integrity. I think this thread has now been officially sidetracked. ![]()
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CptNemo |
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