Tiffany-
They are saying not until first quarter of 2010..but, to be honest, if enough people KNOW about how much the drug is helping and we MAKE a STINK, it is likely that we can put pressure on them to get it passed more quickly.
This happened with AZT and AIDS. The patients and doctors knew it was helping but FDA would not pass it more quickly. The patients were DYING and would not take no for an answer....so, they gt it passed much more quickly because they put pressure on the FDA.
Having said that, there is also a 2 year same species carcinogen trial that needs to happen first as well. That should be over at the end of 2008. With this study done, the drug could conceivably be passed in early 2009....
It is a wait and see game unfortunately. The good news is it truly is a miracle drug.....correcting the the problem at a cellular level is all we want anyway....you don't need gene therapy if the problem is addressed.
The reason they are doing it on such healthy cfers is so the drug can get approved...there are very few side effects in healthy cfers.. Once the drug is approved anyone can try it..and it might even help.
It is just my humble opinion, but I believe that one of the reasons that cfers that have more damage have more side effects with this drug are two-fold. The first is there is obvious damage. The second is....once the channel opens up the efflux of fluid is over-whelming. Most cfers with damge have low gsh and critical antioxidant levels (intracellular and extracellular)...when the flood gates open there is nothing to aid as an anti-inflammatory. You have fluid and nothing to battle oxidative injury...or bacteria for that matter.
When people start glutathione who are older, they are suppose to work up to a maintenance dose to give the body a chance to react to the influx of antioxidant. My guess is that with denufosol it will be the type of thig older or more damaged lungs have to work up to....this was actually observed in the phase II part of the trial. Damaged lungs could handle the 20, 40 dose just had trouble with 60....
Have faith!!! some people will poo-poo it, but it is an amazing drug. A family member of mine recently spoke to the Pres and CEO of the CF Therapeutic division and he told my family person that it is a very exciting drug they expect will change the way cf is viewed forever....THAT IS A BIG STATEMENT!!!!
They are saying not until first quarter of 2010..but, to be honest, if enough people KNOW about how much the drug is helping and we MAKE a STINK, it is likely that we can put pressure on them to get it passed more quickly.
This happened with AZT and AIDS. The patients and doctors knew it was helping but FDA would not pass it more quickly. The patients were DYING and would not take no for an answer....so, they gt it passed much more quickly because they put pressure on the FDA.
Having said that, there is also a 2 year same species carcinogen trial that needs to happen first as well. That should be over at the end of 2008. With this study done, the drug could conceivably be passed in early 2009....
It is a wait and see game unfortunately. The good news is it truly is a miracle drug.....correcting the the problem at a cellular level is all we want anyway....you don't need gene therapy if the problem is addressed.
The reason they are doing it on such healthy cfers is so the drug can get approved...there are very few side effects in healthy cfers.. Once the drug is approved anyone can try it..and it might even help.
It is just my humble opinion, but I believe that one of the reasons that cfers that have more damage have more side effects with this drug are two-fold. The first is there is obvious damage. The second is....once the channel opens up the efflux of fluid is over-whelming. Most cfers with damge have low gsh and critical antioxidant levels (intracellular and extracellular)...when the flood gates open there is nothing to aid as an anti-inflammatory. You have fluid and nothing to battle oxidative injury...or bacteria for that matter.
When people start glutathione who are older, they are suppose to work up to a maintenance dose to give the body a chance to react to the influx of antioxidant. My guess is that with denufosol it will be the type of thig older or more damaged lungs have to work up to....this was actually observed in the phase II part of the trial. Damaged lungs could handle the 20, 40 dose just had trouble with 60....
Have faith!!! some people will poo-poo it, but it is an amazing drug. A family member of mine recently spoke to the Pres and CEO of the CF Therapeutic division and he told my family person that it is a very exciting drug they expect will change the way cf is viewed forever....THAT IS A BIG STATEMENT!!!!