Phase III Combo 809/770

[Bobo]

Hello everybody,

do you know how long phase III of the combo 809/770 is supposed to last? I can't find the answer anywhere. Sorry...

Thanks a lot,

Best regards,
Bobo

 

[Aboveallislove]

It hasn't been announced. It will depend on what the FDA requires. It could be as little as six months or as long as a year. I would guess a year, but have read changes to FDA approval could bring to six months.

 

[Bobo]

Hey Aboveallislove,

thank you for your answer,
wow, i thought it would last over years - that's very good news !

 

[Aboveallislove]

To clarify...individuals would take the drug six months to a year...but it might take longer for everyone in the study to have completed the six month year time...folks start at different time...recruitment takes time. And then they need to analyze results. They'll likely have some continue on for longer term research like they did with kalydeco

 

[Bobo]

As far as i know, recruitment phase is done (as they will start the trial in early 2013..)
do we know if person with urgent need will get it "earlier" ->early program? Has something been said about this?

 

[bigstar]

Im keeping my fingers crossed that this whole thing wont last more than one year and a half. I hope FDA allows a six month phase!