Is AVI going to have trouble getting what I hope is an exon 50 skipping trial going in the US? Is the FDA going to hold that up? I know you said they had hoped to start that in 2010. This is of high inerest for me because it would potentially benefit my son.
Ofelia - so, was there an actual request for a trial in the US by AVI that was put on hold by the FDA? I know you're really up to speed on research and trials - where can I look that kind of stuff up - specifically things that have applied for a trial? I would really like to learn more about this - especially about other potential therapies.
what particular research are you referring to?
I just spoke with Dr. Hoffman, and he is working like crazy to negotiate with AVI on their US exon skipping trials plans. They are also continuously testing promising compounds on their mice, although I'm not sure which ones they're currently working on.
I talked to the ombudsman at the FDA, and she said that the FDA can't share the reasons behind the clinical hold because it's proprietary information. But it's got to be a demand for either additional toxicology or additional efficacy studies...
That's a very good news,but I'm wondering after the FDA approval to begin trails,are we going to start from zerro or we'll continue from where the UK get to? since they already start the trails.