PDA

View Full Version : Aztreonam Update...kinda



MCGrad2006
10-11-2008, 01:09 PM
So I had my clinic visit the other day and got another month of Aztreonam since it has not been approved. I asked the study coordinator what the hell was going on (not really like that tho, lol). All the study coordinator told me was that they submitted the data on Sept 15 and it was rejected on the 16 (yes one day later). It was a matter of efficacy, which is efficiency. I think it basically means they cant decide what the recomended dose will be, i.e. two or three times a day. It is NOT a safety issue and they are still unsure of whether they will need a whole new study or not. I will try to keep you all posted on that in case anyone wants to get in on it, if there is a new study.

I wish I had more info for you all, but they really dont know much yet. Keep praying that it gets approved soon and more people can have access to it.

MCGrad2006
10-11-2008, 01:09 PM
So I had my clinic visit the other day and got another month of Aztreonam since it has not been approved. I asked the study coordinator what the hell was going on (not really like that tho, lol). All the study coordinator told me was that they submitted the data on Sept 15 and it was rejected on the 16 (yes one day later). It was a matter of efficacy, which is efficiency. I think it basically means they cant decide what the recomended dose will be, i.e. two or three times a day. It is NOT a safety issue and they are still unsure of whether they will need a whole new study or not. I will try to keep you all posted on that in case anyone wants to get in on it, if there is a new study.

I wish I had more info for you all, but they really dont know much yet. Keep praying that it gets approved soon and more people can have access to it.

MCGrad2006
10-11-2008, 01:09 PM
So I had my clinic visit the other day and got another month of Aztreonam since it has not been approved. I asked the study coordinator what the hell was going on (not really like that tho, lol). All the study coordinator told me was that they submitted the data on Sept 15 and it was rejected on the 16 (yes one day later). It was a matter of efficacy, which is efficiency. I think it basically means they cant decide what the recomended dose will be, i.e. two or three times a day. It is NOT a safety issue and they are still unsure of whether they will need a whole new study or not. I will try to keep you all posted on that in case anyone wants to get in on it, if there is a new study.

I wish I had more info for you all, but they really dont know much yet. Keep praying that it gets approved soon and more people can have access to it.

MCGrad2006
10-11-2008, 01:09 PM
So I had my clinic visit the other day and got another month of Aztreonam since it has not been approved. I asked the study coordinator what the hell was going on (not really like that tho, lol). All the study coordinator told me was that they submitted the data on Sept 15 and it was rejected on the 16 (yes one day later). It was a matter of efficacy, which is efficiency. I think it basically means they cant decide what the recomended dose will be, i.e. two or three times a day. It is NOT a safety issue and they are still unsure of whether they will need a whole new study or not. I will try to keep you all posted on that in case anyone wants to get in on it, if there is a new study.

I wish I had more info for you all, but they really dont know much yet. Keep praying that it gets approved soon and more people can have access to it.

MCGrad2006
10-11-2008, 01:09 PM
So I had my clinic visit the other day and got another month of Aztreonam since it has not been approved. I asked the study coordinator what the hell was going on (not really like that tho, lol). All the study coordinator told me was that they submitted the data on Sept 15 and it was rejected on the 16 (yes one day later). It was a matter of efficacy, which is efficiency. I think it basically means they cant decide what the recomended dose will be, i.e. two or three times a day. It is NOT a safety issue and they are still unsure of whether they will need a whole new study or not. I will try to keep you all posted on that in case anyone wants to get in on it, if there is a new study.
<br />
<br />I wish I had more info for you all, but they really dont know much yet. Keep praying that it gets approved soon and more people can have access to it.
<br />

Diane
10-11-2008, 05:00 PM
My Dr. mentioned he will,be going to Fla. in 2 weeks for a cf conference and this was going to be one of the topics. I hope they get moving on this medicine, it will probably help a lot of us.

Diane
10-11-2008, 05:00 PM
My Dr. mentioned he will,be going to Fla. in 2 weeks for a cf conference and this was going to be one of the topics. I hope they get moving on this medicine, it will probably help a lot of us.

Diane
10-11-2008, 05:00 PM
My Dr. mentioned he will,be going to Fla. in 2 weeks for a cf conference and this was going to be one of the topics. I hope they get moving on this medicine, it will probably help a lot of us.

Diane
10-11-2008, 05:00 PM
My Dr. mentioned he will,be going to Fla. in 2 weeks for a cf conference and this was going to be one of the topics. I hope they get moving on this medicine, it will probably help a lot of us.

Diane
10-11-2008, 05:00 PM
My Dr. mentioned he will,be going to Fla. in 2 weeks for a cf conference and this was going to be one of the topics. I hope they get moving on this medicine, it will probably help a lot of us.

ladybug
10-11-2008, 08:12 PM
Thanks for the info. Caitlin.... Please do keep us posted if you can. I'd love to get in on the trials this time around (if they do have to do ANOTHER study... gulp) since I wasn't told about the last one by my center at the time.

Thanks,

ladybug
10-11-2008, 08:12 PM
Thanks for the info. Caitlin.... Please do keep us posted if you can. I'd love to get in on the trials this time around (if they do have to do ANOTHER study... gulp) since I wasn't told about the last one by my center at the time.

Thanks,

ladybug
10-11-2008, 08:12 PM
Thanks for the info. Caitlin.... Please do keep us posted if you can. I'd love to get in on the trials this time around (if they do have to do ANOTHER study... gulp) since I wasn't told about the last one by my center at the time.

Thanks,

ladybug
10-11-2008, 08:12 PM
Thanks for the info. Caitlin.... Please do keep us posted if you can. I'd love to get in on the trials this time around (if they do have to do ANOTHER study... gulp) since I wasn't told about the last one by my center at the time.

Thanks,

ladybug
10-11-2008, 08:12 PM
Thanks for the info. Caitlin.... Please do keep us posted if you can. I'd love to get in on the trials this time around (if they do have to do ANOTHER study... gulp) since I wasn't told about the last one by my center at the time.
<br />
<br />Thanks,

mabusincarnate
10-13-2008, 04:44 PM
can anyone get a copy of the statistics report on the trials? i'd like to look at the details.

mabusincarnate
10-13-2008, 04:44 PM
can anyone get a copy of the statistics report on the trials? i'd like to look at the details.

mabusincarnate
10-13-2008, 04:44 PM
can anyone get a copy of the statistics report on the trials? i'd like to look at the details.

mabusincarnate
10-13-2008, 04:44 PM
can anyone get a copy of the statistics report on the trials? i'd like to look at the details.

mabusincarnate
10-13-2008, 04:44 PM
can anyone get a copy of the statistics report on the trials? i'd like to look at the details.

MCGrad2006
10-13-2008, 07:32 PM
<div class="FTQUOTE"><begin quote>can anyone get a copy of the statistics report on the trials? i'd like to look at the details. </end quote></div>

I am not sure that is public information...especially since the FDA and Gilead is still looking at it.

MCGrad2006
10-13-2008, 07:32 PM
<div class="FTQUOTE"><begin quote>can anyone get a copy of the statistics report on the trials? i'd like to look at the details. </end quote></div>

I am not sure that is public information...especially since the FDA and Gilead is still looking at it.

MCGrad2006
10-13-2008, 07:32 PM
<div class="FTQUOTE"><begin quote>can anyone get a copy of the statistics report on the trials? i'd like to look at the details. </end quote></div>

I am not sure that is public information...especially since the FDA and Gilead is still looking at it.

MCGrad2006
10-13-2008, 07:32 PM
<div class="FTQUOTE"><begin quote>can anyone get a copy of the statistics report on the trials? i'd like to look at the details. </end quote>

I am not sure that is public information...especially since the FDA and Gilead is still looking at it.

MCGrad2006
10-13-2008, 07:32 PM
<div class="FTQUOTE"><begin quote>can anyone get a copy of the statistics report on the trials? i'd like to look at the details. </end quote>
<br />
<br />I am not sure that is public information...especially since the FDA and Gilead is still looking at it.

mabusincarnate
10-14-2008, 09:16 PM
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>MCGrad2006</b></i>

<div class="FTQUOTE"><begin quote>can anyone get a copy of the statistics report on the trials? i'd like to look at the details. </end quote></div>



I am not sure that is public information...especially since the FDA and Gilead is still looking at it.</end quote></div>

yea, that's not really what i asked though. ;-P

mabusincarnate
10-14-2008, 09:16 PM
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>MCGrad2006</b></i>

<div class="FTQUOTE"><begin quote>can anyone get a copy of the statistics report on the trials? i'd like to look at the details. </end quote></div>



I am not sure that is public information...especially since the FDA and Gilead is still looking at it.</end quote></div>

yea, that's not really what i asked though. ;-P

mabusincarnate
10-14-2008, 09:16 PM
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>MCGrad2006</b></i>

<div class="FTQUOTE"><begin quote>can anyone get a copy of the statistics report on the trials? i'd like to look at the details. </end quote></div>



I am not sure that is public information...especially since the FDA and Gilead is still looking at it.</end quote></div>

yea, that's not really what i asked though. ;-P

mabusincarnate
10-14-2008, 09:16 PM
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>MCGrad2006</b></i>

<div class="FTQUOTE"><begin quote>can anyone get a copy of the statistics report on the trials? i'd like to look at the details. </end quote>



I am not sure that is public information...especially since the FDA and Gilead is still looking at it.</end quote>

yea, that's not really what i asked though. ;-P

mabusincarnate
10-14-2008, 09:16 PM
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>MCGrad2006</b></i>
<br />
<br /><div class="FTQUOTE"><begin quote>can anyone get a copy of the statistics report on the trials? i'd like to look at the details. </end quote>
<br />
<br />
<br />
<br />I am not sure that is public information...especially since the FDA and Gilead is still looking at it.</end quote>
<br />
<br />yea, that's not really what i asked though. ;-P

MCGrad2006
10-14-2008, 11:39 PM
then what exactly are you looking for?

MCGrad2006
10-14-2008, 11:39 PM
then what exactly are you looking for?

MCGrad2006
10-14-2008, 11:39 PM
then what exactly are you looking for?

MCGrad2006
10-14-2008, 11:39 PM
then what exactly are you looking for?

MCGrad2006
10-14-2008, 11:39 PM
then what exactly are you looking for?