Comments for Salty and Sweet http://saltyandsweet.org Daily life fighting Cystic Fibrosis and Cystic Fibrosis Related Diabetes. Wed, 10 Mar 2010 19:21:14 +0000 http://wordpress.org/?v=2.9.2 hourly 1 Comment on GREAT News!!! by Chris Allen http://saltyandsweet.org/2010/02/23/great-news/comment-page-1/#comment-670 Chris Allen Wed, 10 Mar 2010 19:21:14 +0000 http://saltyandsweet.org/?p=506#comment-670 Thank you for this information. I hope it helps more than just me. Have a great day!!! Chris Kitchen Scales Thank you for this information. I hope it helps more than just me. Have a great day!!!

Chris
Kitchen Scales

]]> Comment on GREAT News!!! by Stephanie Jewett, RN http://saltyandsweet.org/2010/02/23/great-news/comment-page-1/#comment-657 Stephanie Jewett, RN Mon, 01 Mar 2010 16:42:49 +0000 http://saltyandsweet.org/?p=506#comment-657 Great news and interesting blog! Stephanie Great news and interesting blog! Stephanie

]]> Comment on Back in the saddle again by Kristin http://saltyandsweet.org/2010/01/12/back-in-the-saddle-again/comment-page-1/#comment-649 Kristin Tue, 02 Feb 2010 19:47:46 +0000 http://saltyandsweet.org/?p=499#comment-649 Glad to hear that you recovered! Hope that you are feeling stronger these days! Glad to hear that you recovered! Hope that you are feeling stronger these days!

]]> Comment on Back in the saddle again by Kevin http://saltyandsweet.org/2010/01/12/back-in-the-saddle-again/comment-page-1/#comment-640 Kevin Wed, 13 Jan 2010 02:30:24 +0000 http://saltyandsweet.org/?p=499#comment-640 Glad you are starting to feel better. I haven't spoken to you in quite some time. Take care. Glad you are starting to feel better. I haven’t spoken to you in quite some time. Take care.

]]> Comment on oink oink by Corey http://saltyandsweet.org/2009/09/22/oink-oink/comment-page-1/#comment-639 Corey Fri, 08 Jan 2010 23:41:26 +0000 http://saltyandsweet.org/2009/09/22/oink-oink/#comment-639 I keep checking back to see if you have posted since September.. I hope that all is well with you and that you can update soon!! I keep checking back to see if you have posted since September.. I hope that all is well with you and that you can update soon!!

]]> Comment on oink oink by Paolo http://saltyandsweet.org/2009/09/22/oink-oink/comment-page-1/#comment-638 Paolo Sun, 06 Dec 2009 20:42:53 +0000 http://saltyandsweet.org/2009/09/22/oink-oink/#comment-638 I hope you get well soon. The flu isn't dangerous if treated properly. just keep an eye on hygiene. I hope you get well soon. The flu isn’t dangerous if treated properly. just keep an eye on hygiene.

]]> Comment on oink oink by Nathan http://saltyandsweet.org/2009/09/22/oink-oink/comment-page-1/#comment-637 Nathan Sun, 15 Nov 2009 13:29:48 +0000 http://saltyandsweet.org/2009/09/22/oink-oink/#comment-637 Yes, I hope you are doing okay as well - it's been a long time since your last post. Yes, I hope you are doing okay as well – it’s been a long time since your last post.

]]> Comment on oink oink by john http://saltyandsweet.org/2009/09/22/oink-oink/comment-page-1/#comment-636 john Tue, 27 Oct 2009 02:53:11 +0000 http://saltyandsweet.org/2009/09/22/oink-oink/#comment-636 Just stopped buy for the first time in a while. I hope you're doing well and got over the flu! I've been fighting it for almost 3 weeks now (oink oink!) Best wishes and prayers for you! Just stopped buy for the first time in a while. I hope you’re doing well and got over the flu! I’ve been fighting it for almost 3 weeks now (oink oink!)

Best wishes and prayers for you!

]]> Comment on Seriously?! – Dear FDA,… comment reply by Dan http://saltyandsweet.org/2009/08/16/seriously-dear-fda-comment-reply/comment-page-1/#comment-597 Dan Thu, 10 Sep 2009 03:59:00 +0000 http://saltyandsweet.org/?p=489#comment-597 I couldn't agree with you more. In the past the FDA has approved drugs that were harmful and or fatal (vioxx). So I would assume that they are hesitant to approve any drugs, as they approved less than 69 new drugs in 2007, 26% fewer than in 2006. I too have expanded access to Aztreonam, and during my last visit understood that Aztreonam Inhaled was already available in many, many other countries. Giliad was hoping to combine the evidence from the studies done in other countries with the new data from the US head to head, Aztreonam vs.Tobi six month study which will soon close enrollment by the end of the year. I would have done that study, but I have been off of Tobi for too long (as it no longer worked). So like in everything else, the USA is falling farther behind, not being any safer and becoming more and more a large ineffective bureaucracy. Look at how poorly they are in food safety these days. I think they are in need of a reorganization /overhaul more than ever. I couldn’t agree with you more. In the past the FDA has approved drugs that were harmful and or fatal (vioxx). So I would assume that they are hesitant to approve any drugs, as they approved less than 69 new drugs in 2007, 26% fewer than in 2006. I too have expanded access to Aztreonam, and during my last visit understood that Aztreonam Inhaled was already available in many, many other countries. Giliad was hoping to combine the evidence from the studies done in other countries with the new data from the US head to head, Aztreonam vs.Tobi six month study which will soon close enrollment by the end of the year. I would have done that study, but I have been off of Tobi for too long (as it no longer worked). So like in everything else, the USA is falling farther behind, not being any safer and becoming more and more a large ineffective bureaucracy. Look at how poorly they are in food safety these days. I think they are in need of a reorganization /overhaul more than ever.

]]> Comment on What in the world? by Nathan http://saltyandsweet.org/2009/08/24/what-in-the-world/comment-page-1/#comment-549 Nathan Thu, 27 Aug 2009 12:28:51 +0000 http://saltyandsweet.org/?p=494#comment-549 Well, not so great news on Miglustat. I've been checking for updates on the Miglustat clinical trial, and noticed this morning that the Bio-IT World story has changed. When the story was first posted July 22nd, the story said that the study had concluded and that Actelion was "currently reviewing the results". Now the story says, "After reviewing the results of the Phase IIa study, Actelion decided not to continue clinical development for the time being. But in light of the French team's results (the study of Miglustat in CF respiratory cells), Actelion has decided to conduct further preclinical evaluation of the drug in CF before making any final decisions". This is both disappointing and frustrating. There is no mention in the Bio-IT World story of an update to the original posting. After digging around more on the Actelion website, I found in the press release, "Actelion announces Half Year financial results 2009" the same line, "The recently concluded Phase IIa proof-of-concept study does not support further clinical development at this time...". This seems to be the only information they give. They do not include any information about the clinical trial data that leads them to this decision. I will look into this more and send along any interesting information I find. I apologize for getting anyone's hopes up over this trial. As someone with CF, I was very hopeful myself that this would be a new and revolutionary treatment option. I am still hopeful that someone (maybe Vertex, maybe someone else) will develop a successful CFTR corrector that will be that next big step in CF treatment. Well, not so great news on Miglustat. I’ve been checking for updates on the Miglustat clinical trial, and noticed this morning that the Bio-IT World story has changed. When the story was first posted July 22nd, the story said that the study had concluded and that Actelion was “currently reviewing the results”. Now the story says, “After reviewing the results of the Phase IIa study, Actelion decided not to continue clinical development for the time being. But in light of the French team’s results (the study of Miglustat in CF respiratory cells), Actelion has decided to conduct further preclinical evaluation of the drug in CF before making any final decisions”.

This is both disappointing and frustrating. There is no mention in the Bio-IT World story of an update to the original posting. After digging around more on the Actelion website, I found in the press release, “Actelion announces Half Year financial results 2009″ the same line, “The recently concluded Phase IIa proof-of-concept study does not support further clinical development at this time…”. This seems to be the only information they give. They do not include any information about the clinical trial data that leads them to this decision. I will look into this more and send along any interesting information I find.

I apologize for getting anyone’s hopes up over this trial. As someone with CF, I was very hopeful myself that this would be a new and revolutionary treatment option. I am still hopeful that someone (maybe Vertex, maybe someone else) will develop a successful CFTR corrector that will be that next big step in CF treatment.

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