User talk:Bluerasberry: Difference between revisions
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:::I will see if I can compile a Wikipedia article about social activism in the FDA approval process. |
:::I will see if I can compile a Wikipedia article about social activism in the FDA approval process. |
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::: Is there a name for the business model of using a small company to introduce a single drug? I have heard the narrative about 10 years and a billion dollars to bring a drug to market. The part that I wish to know more about is when this kind of investment started coming from small companies with a single drug as their only product. It makes sense that funding would happen in stages in any case, but I still wonder how anyone other than a major pharma company would be able to plan to invest the billion dollars, and when market conditions began to allow small groups of investors to collect money in this way and bring their own drug to market. I wonder what drugs are the product of single-drug companies, and which single-drug companies have investors in common. Also I wonder if there are enough drugs from single-drug companies to generalize traits of them - are drugs from small companies more likely to have safety problems? Do investors in these companies have greater appetite for risk than major pharma companies? Are they more likely to do social campaigns to get their drugs approved? Is there even a name for this kind of development model? Is this common? Is looking at companies like this a topic of research? I am not sure where to begin asking questions but I wonder what if anything has ever been said on this model. It seems so different from big pharma that I wonder if anyone has described this system in a way that could be a Wikipedia article. [[User:Bluerasberry|<span style="background:#cedff2;color:#11e">''' Blue Rasberry '''</span>]][[User talk:Bluerasberry|<span style="background:#cedff2;color:#11e">(talk)</span>]] 18:14, 10 August 2015 (UTC) |
::: Is there a name for the business model of using a small company to introduce a single drug? I have heard the narrative about 10 years and a billion dollars to bring a drug to market. The part that I wish to know more about is when this kind of investment started coming from small companies with a single drug as their only product. It makes sense that funding would happen in stages in any case, but I still wonder how anyone other than a major pharma company would be able to plan to invest the billion dollars, and when market conditions began to allow small groups of investors to collect money in this way and bring their own drug to market. I wonder what drugs are the product of single-drug companies, and which single-drug companies have investors in common. Also I wonder if there are enough drugs from single-drug companies to generalize traits of them - are drugs from small companies more likely to have safety problems? Do investors in these companies have greater appetite for risk than major pharma companies? Are they more likely to do social campaigns to get their drugs approved? Is there even a name for this kind of development model? Is this common? Is looking at companies like this a topic of research? I am not sure where to begin asking questions but I wonder what if anything has ever been said on this model. It seems so different from big pharma that I wonder if anyone has described this system in a way that could be a Wikipedia article. [[User:Bluerasberry|<span style="background:#cedff2;color:#11e">''' Blue Rasberry '''</span>]][[User talk:Bluerasberry|<span style="background:#cedff2;color:#11e">(talk)</span>]] 18:14, 10 August 2015 (UTC) |
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== St. George's University page == |
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Hi Lane, I hope all's going well. I'm with the communications department at SGU. I had made edits to the SGU page, basically just putting a bunch of markety stuff on there because it hadn't been updated in a long time. A lot was deleted, which I'm OK with - I understand there are rules and we can abide by them. Can you point me to the guidelines for a university or an educational institution in general? I looked at the pages for some of our competitors (Ross and AUA for example: https://en.wikipedia.org/wiki/Ross_University_School_of_Medicine; https://en.wikipedia.org/wiki/American_University_of_Antigua). Even Yale (https://en.wikipedia.org/wiki/Yale_School_of_Medicine). I think they're all a cross between what's there now and what I had added, mostly without the figures we had added. Let me know. Thanks! |
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Brett |
Revision as of 18:49, 10 August 2015
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Cardio First Angel - continuation
Hi Bluerasberry, Thanks for your advice. I have use three sources from which I wrote an article. I wasn't sure where to put this article, if in the sandbox or somewhere else. I still find orientation in Wikipedia rather confusing. So, I am sending you my article as part of my message below. I wanted to inclose also a picture of the Cardio First Angel, so people would see how it looks like (my picture), but have no idea where to enclose it. Please let me know the outcome. Thanks Animall
The Article:
The Cardio First Angel
The Cardio First Angel is a medical device which was co-invented by the cardiologist Prof. Dr. Christian Hagl. It has been developed to improve the consistency and quality of manual chest compressions during administration of a heart massage. There was conducted a clinical trial or a Pilot Study of the effect of a Cardio First Angel (CFA) device on CPR. The goal was to find out what was the effect by using a Cardio First Angel on patient survival. The CPRs were randomly performed on various patients using Cardio First Angel. It was concluded that with a Cardio First Angel used by the manufacturer’s guidelines a quality CPR was performed with consistency of the chest compressions. The Pilot Study was provided by Baqiyatallah Medical Sciences University. https://clinicaltrials.gov/ct2/show/study/NCT02394977?view=results
There was a study in Herzchirurgische Klinik des Universitätsklinikums München, Department of Medical Informatics, Biometry and Epidemiology (IBE) where 205 people performed CPR. Firstly they performed CPR just with their knowledge using their hands only. The second time they were using the Cardio First Angel for resuscitation without any instruction how to use it. 38% achieved improvement with compression depth and 33.3% of these people had visible improvement in compression rate when used the Cardio First Angel. 66.2% of people said that they would be happy to use it again, because they didn’t need to be in a physical contact with the patient and because Cardio First Angel was very easy to use even without any prior knowledge. 100% of people placed Cardio First Angel in its correct position.
Christian Heinrich wrote an article in Spiegel Online about Cardio First Angel (CFA) expressing a view that this medical device is a great help in saving people’s lives after a heart attack. The main reasons being that it not only eliminates laymen worry in regard where to place hands or how strong should be a chest compression, but that there is no need of a contact with a patient. The Cardio First Angel consists of combination of springs, when correct pressure is delivered audio feedback by “klick” is heard. When the springs are released, another sound “klack” is heard. The bottom of CFA is from foam surface. On the top is a large red button on which lay rescuer applies pressure by hands. This device is purely mechanical and no batteries or electricity is present. This means that Cardio First Angel is always ready to use. Mr. Christian Heinrich believes that the Cardio First Angel should be placed in the public places, businesses, homes as well as in cars due to its small size and easy transportation. http://www.spiegel.de/gesundheit/diagnose/reanimation-cardio-first-angel-fuer-bessere-wiederbelebung-a-992407.html
Nomination of Victoria Taylor for deletion
A discussion is taking place as to whether the article Victoria Taylor is suitable for inclusion in Wikipedia according to Wikipedia's policies and guidelines or whether it should be deleted.
The article will be discussed at Wikipedia:Articles for deletion/Victoria Taylor (2nd nomination) until a consensus is reached, and anyone is welcome to contribute to the discussion. The nomination will explain the policies and guidelines which are of concern. The discussion focuses on high-quality evidence and our policies and guidelines.
Users may edit the article during the discussion, including to improve the article to address concerns raised in the discussion. However, do not remove the article-for-deletion notice from the top of the article. -- Callinus (talk) 01:19, 13 July 2015 (UTC)
Wikimedia LGBT+ User Group
Hello,
Thank you for expressing interest in our proposed presentation on the Wikimedia LGBT+ User Group. Unfortunately, this proposal was not accepted by the Programme Committee and therefore will not be presented this year. However, you are still welcome to visit our stand in the Community Village and to attend the LGBT Meetup. For more information, please review the Wikimedia LGBT+ User Group at Wikimania 2015 page. I hope you enjoy Wikimania! Kind regards, CT Cooper · talk 06:43, 14 July 2015 (UTC)
Canada and United States affiliates meetup invite
Hi, Bluerasberry! Even though you obviously already know about this, I thought that I would give you a chance to see the banner that I have been posting on various Wikimedia projects. The code is at wm2015::Template:Canada and United States affiliates meetup invite, although I have been only using it as a template on wm2015 itself & otherwise have been posting the table/wikimarkup itself on other projects. Peaceray (talk) 19:28, 14 July 2015 (UTC)
Wikipedia:Miscellany for deletion/Draft:Nalini Prava Deka
You are invited to join the discussion at Wikipedia:Miscellany for deletion/Draft:Nalini Prava Deka. You've previously reviewed this draft. Thanks. APerson (talk!) 12:15, 16 July 2015 (UTC)Template:Z48
My RfA
Thank for !voting at my recent RfA. You voted Support so you get a whopping three cookies, fresh from the oven! |
Please comment on Talk:Microsoft Surface
The feedback request service is asking for participation in this request for comment on Talk:Microsoft Surface. Legobot (talk) 00:03, 24 July 2015 (UTC)
Sunday August 2: WikNYC Picnic
Sunday August 2, 1-7pm: WikNYC Picnic | |
---|---|
You are invited to join us the "picnic anyone can edit" in Brooklyn's Prospect Park, as part of the Great American Wiknic celebrations being held across the USA. Remember it's a wiki-picnic, which means potluck.
We hope to see you there! --Pharos (talk) 03:31, 24 July 2015 (UTC) (Bonus event: WikiWednesday Salon @ Babycastles - Wednedsay, August 19) |
(You can subscribe/unsubscribe from future notifications for NYC-area events by adding or removing your name from this list.)
Meetup to revitalize & prioritize WikiProject Seattle
- Yours, Peaceray
- To unsubscribe from future messages from Wikipedia:Meetup/Seattle, please remove your name from this list. -MediaWiki message delivery (talk) 05:35, 24 July 2015 (UTC)
Article deletions
Hello.
Hope you recall our meeting at Wikimania.
As discussed, please find the link to at least two deleted articles on AIDS Control Societies in India in this section of En:WP admin's talk page.
Can you ensure restoration or an explanation as to why deletion was so desperately needed? --Muzammil (talk) 09:06, 25 July 2015 (UTC)
- Hindustanilanguage I had this article restored to User:Bluerasberry/Lakshadweep. I presume it was deleted because of the sources cited. There are three here. One is a dead link, the other is an audit which was commissioned by the organization (so self published), and the other is by the government office which funds this organization which is also self-published.
- Right now Wikipedia does not make articles for every government office. With an annual budget of 30 lakhs, this is not even a very large organization.
- Still - I would like regional health offices to be listed somehow. Without more sources, it would be difficult to include this into Wikipedia. It could be listed in Wikidata more easily, or maybe we could think more about this. Blue Rasberry (talk) 16:29, 29 July 2015 (UTC)
- If there is RfD, probably I or somebody else could have added more links. NACO is something like NIH of USA - if NIH can be referred on WP, why not NACO? What about Tamil Nadu State AIDS Control Society? This way it ensures that AIDS Control Agencies in India are not showcased on English Wikipedia at all!! --Muzammil (talk) 10:33, 31 July 2015 (UTC)
A kitten for you!
Thanks for all your help! I was wondering if you knew how to embed YouTube videos in a Wikipedia article? I drafted an article for Choosing Wisely Canada, and it recently got approved! Looking forward to the class on Wednesday!
Adl265 (talk) 18:11, 27 July 2015 (UTC)
Absolutely Amazing eBooks
Continued from User_talk:Bluerasberry/Archive_27#references_are_still_not_doing_the_trick Blue Rasberry (talk) 13:21, 30 July 2015 (UTC)
Hello again. I am not giving up. I think this page should be on Wikipedia. I am sending you these references and I hope they will do the trick I know the first reference is OK as it was approved already. Please let me know I am not sure what to do now Still love that picture of your hamster
Interview about Absolutely Amazing eBooks on Good Morning Florida Keys with Jenna Stauffer (https://www.youtube.com/watch?v=yq_oWM0QYCQ). Interview with Shirrel Rhoades in Florida Keys Weekly (http://www.absolutelyamazingebooks.com/images/newsaboutaaeb/Keys%20Weekly%20Sept%2022%202012.pdf). Longtime Washingtonian Magazine editor jack Limbert wrote a column about Absolutely Amazing eBooks (http://jacklimpert.com/2014/05/writing-well-still-plausible-way-make-living/).
Ebooks
yes? what do I do next to get this page up and approved? Please help. Keywestbookworm (talk) 16:15, 18 July 2015 (UTC)
- Keywestbookworm Can you reply to my comment at Draft:Absolutely_Amazing_ebooks? Some of the sources you provided do not meet WP:RS. 2-3 sources have to be identified and this is not done yet. Blue Rasberry (talk) 16:18, 18 July 2015 (UTC)
Hello again Dear Bluerasberry: The three sources I gave you last time around were about AAeB and published by Florida Keys Weekly Newspaper, an online blog, and Channel 19.
Interview about Absolutely Amazing eBooks on Good Morning Florida Keys with Jenna Stauffer (https://www.youtube.com/watch?v=yq_oWM0QYCQ). Interview in Florida Keys Weekly (http://www.absolutelyamazingebooks.com/images/newsaboutaaeb/Keys%20Weekly%20Sept%2022%202012.pdf). Longtime Washingtonian Magazine editor jack Limbert wrote a column that talks about Absolutely Amazing eBooks (http://jacklimpert.com/2014/05/writing-well-still-plausible-way-make-living/).
That was exactly what you asked to send and I am very frustrated and confused as to what is needed. I have looked at the rules and as far as I can tell the these three fit the requirements. You have said I need three sources and have approved the Channel 19 source so why doesn't the Florida Keys Weekly Newspaper source and the online blog source count?
I am sorry to be going on about this but I think this page should be included in Wikipedia so I am going to keep trying and I just want to get it right. Please help and thanks Keywestbookworm (talk) 12:11, 30 July 2015 (UTC)
- Keywestbookworm Good job finding the Florida Keys Weekly source! That and the Good Morning Florida Keys source makes two sources, and this meets Wikipedia's minimal criteria. If you put those two sources in your draft, and the article's information only comes from what is found in those two sources, then the draft can go live.
- The subject of the Jack Limbert source is an author, not the publisher, so that source does not meet Wikipedia's criteria. If you wish to prevent any doubt in creating the article, find a third source which features the publisher as the subject. Otherwise - you have met the minimal criteria and can resubmit the article if you like. Blue Rasberry (talk) 13:28, 30 July 2015 (UTC)
Hey, thought you might be interested to know that Medicine.wiki is now active, in case you and/or other Wiki Project Med participants want to contribute in some way. ---Another Believer (Talk) 19:31, 30 July 2015 (UTC)
A barnstar for you!
The Half Barnstar | |
This is half a barnstar as I'm hoping that you will pass the other half onto the artist of the wonderful image appearing at Jashodaben Narendrabhai Modi. Thanks for doing the work to transfer the copyright - do pass on our best wishes. Victuallers (talk) 10:16, 31 July 2015 (UTC) |
ArbCom case "Editor conduct in e-cigs articles" has now been opened
You recently offered a statement in a request for arbitration. The Arbitration Committee has accepted that request for arbitration and an arbitration case has been opened at Wikipedia:Arbitration/Requests/Case/Editor conduct in e-cigs articles. Evidence that you wish the arbitrators to consider should be added to the evidence subpage, at Wikipedia:Arbitration/Requests/Case/Editor conduct in e-cigs articles/Evidence. Please add your evidence by August 18, 2015, which is when the evidence phase closes. You can also contribute to the case workshop subpage, Wikipedia:Arbitration/Requests/Case/Editor conduct in e-cigs articles/Workshop. For a guide to the arbitration process, see Wikipedia:Arbitration/Guide to arbitration. For the Arbitration Committee, Lankiveil (speak to me) 11:24, 4 August 2015 (UTC)
Need your support
Hi, I hope you are doing fine.
We recently had a discussion on the State of New York University page about merging the board of trustees page with the university page.
I wanted to let you know that the page of one of the trustees Joseph Belluck has been nominated for deletion. I would really appreciate it if you could support the page so that it is not deleted: https://en.wikipedia.org/wiki/Wikipedia:Articles_for_deletion/Joseph_Warren_Belluck
Thank you very much Nwerner1 (talk) 13:34, 7 August 2015 (UTC)
Hi Bluerasberry. There is an RFC here that hasn't attracted any comments as of yet through the normal RFC process (only editors I've pinged). I noticed that you were one of the most active editors at WikiProject medicine and you're probably the only editor I know that is active on medical topics anyway, besides @Anthonyhcole:, who I already pinged about this page back in January. It is a pretty high-investment discussion where you'd have to read through some of the discussion and the article-content and maybe that's scared off a few folks. Getting the medical literature down is the only thing that's really still needed to get this GAN-ready.
BTW - I've actually been working on Acupuncture on a volunteer basis, mostly focusing on the non-medical stuff (History, Adoption, etc.) and rather enjoyed it. It's obviously (IMO) not a real treatment, but it's interesting seeing how they myth has spread and evolved over time.
PS - were you the one that told me that the "Intro" section where a study's author summarizes the literature was a MEDRS-compliant secondary source? @Doc James: said you couldn't use any portion of a source where original experimental results are introduced and that made the body of source material much more manageable. CorporateM (Talk) 05:33, 8 August 2015 (UTC)
- User:CorporateM you are allowed to notify an entire project to request further input on an issue. Going to one specific editor and making them aware that you want their input is generally not kosher. Doc James (talk · contribs · email) 06:03, 8 August 2015 (UTC)
One of WikiProject Food and Drink's articles has been selected for improvement!
Hello, |
Bananasoldier (talk) 02:22, 10 August 2015 (UTC)
Sex, drugs, and money
(catchy header, right?) About this. As you know, I work with early stage biomedical stuff, and am very aware of how much work has to be done, to develop a medical product, from an early stage idea. And there is a high chance of failure. That work requires money. In a capitalist system, that money comes from the private sector, which has lots and lots of investment opportunities, all the time. So why would any sane person, invest their money in an early stage biomedical product? Their money will be tied up for years, and there is a high chance all their money will be lost. This is why patents are so important in the biomedical space. After development is done, if (and it is a big if) it is successful, there will be a few years left on the patent, during which the investors can get their money back (and then some - they were investors, after all). Then the patents expire, competition will come in, and prices will fall. That is how it works.
The story with flibanserin is that Boehringer gave up on it, and yes, a startup was formed to get investment to try another time to do trials and see if they could show it worked and get it to market. There is nothing "fishy" about that per se, in my view. Do you see what I mean?
With regard to the medicalization of sex... I am not sure what you are struggling with there. Apparently a bunch of guys had a hard time getting erections, and now with viagra etc they can. I don't see that as a bad thing. Sprout is trying to do the same for women whose bodies don't respond sexually as they would like.... and I don't see that as a bad thing either. It is isn't clear to me what you are objecting to with the "medicalization of sex" thing. I think there are important questions about where our health care dollars go, as a society, and for sure about making sure there is fair access for everybody (e.g. reimbursement for contraception).... but I don't understand where you are coming from on that, and would be interested to hear more.
If you don't want to discuss, I would understand that too. Jytdog (talk) 13:51, 10 August 2015 (UTC)
- Jytdog Where I can I read more about the drug development model in which small companies bring drugs to market? How long has this been a thing? Is this a way of divesting liability of medical harm, and not just about divesting financial liability?
- With Flibanserin, the accusation that I heard is that the drug has failed FDA approval in the past. In response, re-submission for review came with funding to community organizers to develop a public campaign that framed the FDA rejection as discriminatory. Viagra, for example, might have been just as risky, but since that was for men it passed, whereas Flibanserin was rejected even though it is similar. I have not examined these arguments but with articles like this one on NPR, I wish that social campaigning was not a compelling factor in deciding that drugs come to market. I might also ask how long social campaigning has been a factor in granting FDA approval - with HIV it was, but I am not sure if cases are documented before or after that.
- I might like to see Wikipedia articles for "one-drug company" and "Social campaigning for FDA approval". I have not even begun to search for whether these things exist on wiki or in the literature. I do not feel strongly about this - I am just curious. Blue Rasberry (talk) 14:25, 10 August 2015 (UTC)
- in what i wrote above, what i focused on, was the work required to try again with the FDA - Sprout conducted another clinical trial, I think. You are raising a good point, with the social marketing campaign that they did. Drug companies have a function that they call "market access" in which people who do regulatory, reimbursement, and marketing work. (all the things you need to address, to actually get the drug into people's hands). For drug companies, patient advocacy groups are great for two reasons - the first is recruitment for clinical trials, and the second is getting the word out, for whatever is needed. Yes, if a drug company is having trouble at the FDA, they may try to mobilize advocacy groups. I understand that Sprout went even further and set up an astroturf one. Definite financial COI going on there. Whether their actual message has caught on with some women who have had problems, and want the opportunity to see if this drug will help them, I don't know. There is huge tension around the role of the FDA in all this stuff. On the one hand you have the Abigail Alliance which basically wants the FDA to get the hell out of the way of patient's access to drugs, and on other hand you have people really angry with the FDA for ever letting drugs like Avandia and Vioxx ever get to market. The FDA needs to be in the middle but they are always attacked by extremists on both sides. Hard.
- The whole thing about the time and money it takes to bring a medical product to market is not about liability, but about the actual money you need. It is.... what it is, whether an established company like Pfizer is starting down that road or whether it is a startup. If you do every single step of discovery and development perfectly (hitting the bulls eye early on at each step) it takes something like $200M and eight years to go from start to finish. If things work out normally where there is a lot of trial and error, it is more like $1B and 12 years. That is how hard the science is. Pfizer will use its own money, and a startup has to raise it, but the time and risk are the same. The real problem a startup has, is that it can only raise money in small chunks. (Pfizer has huge bank accounts, and once it starts something there is no doubt it can finish.) Most startups fail because they run out of money - they can't raise their next round of funding or do the deal (like a partnership deal with a bigger company) that will take them their next step. A lot of companies deserve to die b/c their idea didn't work, but a lot of cool ideas have been shipwrecked by bad captaining. Which is tragic.... sometimes the thing can be relaunched (erbitux was in the hands of two companies before Imclone got it) but not always.
- It is not surprising to me that Sprout was able to get funding, since so much work had already been done and there are no competing drugs at this time. It is true that it had failed at the FDA before - that is why Boeheringer gave up on it (boeheringer first developed it as antidepressant than shifted to the hypoarousal indication). But some folks wanted to try again. All the time people see flaws in clinical trials other people did, and think that if they do it different, they might get a better outcome. So they raised money and launched Sprout to try again. (see here and here - for example - Sprout tried to raise $5M in 2012 and took $20M b/c interest from investors was so strong. I need to read more on how much they raised when they launched in 2010 and what they actually did with all the money they raised - what trials they did and how they were different from B-I's trials) But the outcomes that Sprout got from their trials were clearly not as good as what they hoped for - they have "gone for it" anyway. So we have this messy current situation. hm. happy to talk more and send you stuff to read on any of that, if you like. Jytdog (talk) 14:56, 10 August 2015 (UTC)
- Jytdog
- I will see if I can compile a Wikipedia article about social activism in the FDA approval process.
- Is there a name for the business model of using a small company to introduce a single drug? I have heard the narrative about 10 years and a billion dollars to bring a drug to market. The part that I wish to know more about is when this kind of investment started coming from small companies with a single drug as their only product. It makes sense that funding would happen in stages in any case, but I still wonder how anyone other than a major pharma company would be able to plan to invest the billion dollars, and when market conditions began to allow small groups of investors to collect money in this way and bring their own drug to market. I wonder what drugs are the product of single-drug companies, and which single-drug companies have investors in common. Also I wonder if there are enough drugs from single-drug companies to generalize traits of them - are drugs from small companies more likely to have safety problems? Do investors in these companies have greater appetite for risk than major pharma companies? Are they more likely to do social campaigns to get their drugs approved? Is there even a name for this kind of development model? Is this common? Is looking at companies like this a topic of research? I am not sure where to begin asking questions but I wonder what if anything has ever been said on this model. It seems so different from big pharma that I wonder if anyone has described this system in a way that could be a Wikipedia article. Blue Rasberry (talk) 18:14, 10 August 2015 (UTC)
St. George's University page
Hi Lane, I hope all's going well. I'm with the communications department at SGU. I had made edits to the SGU page, basically just putting a bunch of markety stuff on there because it hadn't been updated in a long time. A lot was deleted, which I'm OK with - I understand there are rules and we can abide by them. Can you point me to the guidelines for a university or an educational institution in general? I looked at the pages for some of our competitors (Ross and AUA for example: https://en.wikipedia.org/wiki/Ross_University_School_of_Medicine; https://en.wikipedia.org/wiki/American_University_of_Antigua). Even Yale (https://en.wikipedia.org/wiki/Yale_School_of_Medicine). I think they're all a cross between what's there now and what I had added, mostly without the figures we had added. Let me know. Thanks!
Brett