6-11 809/Kalydeco study

[Aboveallislove]

Has been on hold for what seems like forever. Vertex keeps saying they are doing but no updates for over a year. Anyone talking with clinic on this? If not, anyone in Indianapolis, K.C., St. Louis, Salt Lake City, Boston, Birmingham, up for calling the coordinator and seeing when they'll be starting? And maybe get a head start for your little ones to be in the 6-11 study?
Here's the link:
https://clinicaltrials.gov/ct2/show/NCT01897233?term=vx809&rank=6

 

[static]

Have to remember it is still just a study, if they had exciting news we would of probably heard testimonials by now.
Scientifically speaking they go for safety first, then effectiveness. I bet they are even more cautious with children since they are not done developing yet.

 

[Aboveallislove]

Sorry, I wasn't clear. I meant I want to know when they are starting the study/starting recruiting. The 6-11 in US is only for safety. FDA will approve 6-11 based on 12 and over PK results, if safe. I'm not looking for any exciting news, just when they are going to start recruiting and dosing.

 

[static]

Well my post was more in response as to why it may be delayed.

I'd say go straight to the source. Shoot an email to the study coordinators in those areas and they may be able to give you a more accurate timeline

 

[Aboveallislove]

ah, yeah. I didn't think safety was an issue because of it clearing with 12 and older and the purpose being dosing. But I know what you mean.
I don't want to waste the coordinators time since we aren't near enough to participate, but figured if someone who is going to try to participate called it wouldn't waste their time because they'd be able to get the process started for their little ones at the same time (and share any info.) Thanks Static!