A new drug application for bronchitol (dry-powder mannitol) was submitted to the FDA this summer (May) and Pharmaxisis projecting approval by March 2013 (http://202.66.146.82/listco/au/pharmaxis/interim/2012/int4qrep.pdf). With this being the case I'm wondering if there are or will be soon means to get this drug early on compassionate grounds (as was the case with Kalydeco). I'm not exactly sure how that sort of thing works so hence why I'm asking.
If not, I was also thinking, now that the drug is available in other countries, would it be possible to get the drug from over seas (of course assuming one would have to pay for the drug themselves). If this drug works as well as they say (see media release: http://member.afraccess.com/media?id=CMN://2A681756&filename=20120608/PXS_01304169.pdf), those who are really sick shouldnt have to wait another year for it. (I've been thinking about this as I've seen individuals in other countries taking the initiative to get Kalydeco, when it will not be approved for a long time there).
Also anyone who has been on this drug or is now getting it in europe, please post your thoughts about the drug and etc.
Thanks so much!!!
If not, I was also thinking, now that the drug is available in other countries, would it be possible to get the drug from over seas (of course assuming one would have to pay for the drug themselves). If this drug works as well as they say (see media release: http://member.afraccess.com/media?id=CMN://2A681756&filename=20120608/PXS_01304169.pdf), those who are really sick shouldnt have to wait another year for it. (I've been thinking about this as I've seen individuals in other countries taking the initiative to get Kalydeco, when it will not be approved for a long time there).
Also anyone who has been on this drug or is now getting it in europe, please post your thoughts about the drug and etc.
Thanks so much!!!