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FDA turned them down. The FDA wants more data. GSK is responding by moving forward in the EU, and possibly Canada, only, rather than providing the FDA with what they want.
I'm so glad we have a government agency that will defend our right to die of a terminal disease so vehemently.
And yet I can still eat BPA in my food with no complaints from them at all...
That is what is so surprising. The FDA has already approved the trial for the non-ambulatory boys and that trial is already enrolling participants. GSK has said NOTHING other than the ambulatory trial with the same drug will not happen this year. Since the FDA has approved the one trial, it seems to make sense that they are waiting on that data before giving final approval to GSK for the Phase III we are all waiting for. The FDA is VERY wary about approving trial on humans. The FDA has neither approved or flatly denied anything yet - other than this non ambulatory trial. That is a start. We all know Canada and Europe are far more lax in their requirements for new drugs. The US healthcare is primarily run by the greedy pharmaceutical companies and they want to make money. How much do they stand to make on this new drug???
Mindy said:FDA turned them down. The FDA wants more data. GSK is responding by moving forward in the EU, and possibly Canada, only, rather than providing the FDA with what they want.
I'm so glad we have a government agency that will defend our right to die of a terminal disease so vehemently.
And yet I can still eat BPA in my food with no complaints from them at all...
Avii is our best chance right now but folks seem to fixated on GSK
irishgirl said:That is what is so surprising. The FDA has already approved the trial for the non-ambulatory boys and that trial is already enrolling participants. GSK has said NOTHING other than the ambulatory trial with the same drug will not happen this year. Since the FDA has approved the one trial, it seems to make sense that they are waiting on that data before giving final approval to GSK for the Phase III we are all waiting for. The FDA is VERY wary about approving trial on humans. The FDA has neither approved or flatly denied anything yet - other than this non ambulatory trial. That is a start. We all know Canada and Europe are far more lax in their requirements for new drugs. The US healthcare is primarily run by the greedy pharmaceutical companies and they want to make money. How much do they stand to make on this new drug???
Mindy said:FDA turned them down. The FDA wants more data. GSK is responding by moving forward in the EU, and possibly Canada, only, rather than providing the FDA with what they want.
I'm so glad we have a government agency that will defend our right to die of a terminal disease so vehemently.
And yet I can still eat BPA in my food with no complaints from them at all...
Isn't this just disgusting? I wasn't this upset in a LONG time. I'm looking into moving out of this country. I am now convinced that any DMD medication will be approved here years after EU or Canada which should not be allowed! Why the h@#%^% doesn't my son have the same right to live as any other boy in other countries?
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