Gilead

[TwistedTanya]

That's so stupid! At least I am still in the study and the AZLI is wonderful! I feel like crap when I'm off it and get sick. When I'm on it, I feel sooooo much better and have more energy. I don't understand why there is such a problem getting it approved when it works so well!

 

[TwistedTanya]

That's so stupid! At least I am still in the study and the AZLI is wonderful! I feel like crap when I'm off it and get sick. When I'm on it, I feel sooooo much better and have more energy. I don't understand why there is such a problem getting it approved when it works so well!

 

[TwistedTanya]

That's so stupid! At least I am still in the study and the AZLI is wonderful! I feel like crap when I'm off it and get sick. When I'm on it, I feel sooooo much better and have more energy. I don't understand why there is such a problem getting it approved when it works so well!

 

[TwistedTanya]

That's so stupid! At least I am still in the study and the AZLI is wonderful! I feel like crap when I'm off it and get sick. When I'm on it, I feel sooooo much better and have more energy. I don't understand why there is such a problem getting it approved when it works so well!

 

[TwistedTanya]

That's so stupid! At least I am still in the study and the AZLI is wonderful! I feel like crap when I'm off it and get sick. When I'm on it, I feel sooooo much better and have more energy. I don't understand why there is such a problem getting it approved when it works so well!

 

[saveferris2009]

So what they gave to the FDA was a 28 day placebo controlled study and an extended open label study.

This is very different from what Chiron gave to the FDA for TOBI - they gave 2, 24 week placebo controlled studies.... much more data than what Gilead has provided.

28 days simply isn't enough data for the FDA... looks like Gilead will have to go back and do at least one more placebo controlled study for much longer than just 1 month.

 

[saveferris2009]

So what they gave to the FDA was a 28 day placebo controlled study and an extended open label study.

This is very different from what Chiron gave to the FDA for TOBI - they gave 2, 24 week placebo controlled studies.... much more data than what Gilead has provided.

28 days simply isn't enough data for the FDA... looks like Gilead will have to go back and do at least one more placebo controlled study for much longer than just 1 month.

 

[saveferris2009]

So what they gave to the FDA was a 28 day placebo controlled study and an extended open label study.

This is very different from what Chiron gave to the FDA for TOBI - they gave 2, 24 week placebo controlled studies.... much more data than what Gilead has provided.

28 days simply isn't enough data for the FDA... looks like Gilead will have to go back and do at least one more placebo controlled study for much longer than just 1 month.

 

[saveferris2009]

So what they gave to the FDA was a 28 day placebo controlled study and an extended open label study.

This is very different from what Chiron gave to the FDA for TOBI - they gave 2, 24 week placebo controlled studies.... much more data than what Gilead has provided.

28 days simply isn't enough data for the FDA... looks like Gilead will have to go back and do at least one more placebo controlled study for much longer than just 1 month.

 

[saveferris2009]

So what they gave to the FDA was a 28 day placebo controlled study and an extended open label study.
<br />
<br />This is very different from what Chiron gave to the FDA for TOBI - they gave 2, 24 week placebo controlled studies.... much more data than what Gilead has provided.
<br />
<br />28 days simply isn't enough data for the FDA... looks like Gilead will have to go back and do at least one more placebo controlled study for much longer than just 1 month.
<br />