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* Gilead seeking approval for aztreonam
- Thread starter Brad
- Start date
saveferris2009
New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>bkc3</b></i>
The latest posting from Gilead seems fairly promising. I think sometimes when a company is trying to hurry things along, they don't do a very good job of organizing, designing and performing their studies. When this happens, it seems like more time is taken trying to recover and do things the "right" way. It sounds like this will be another weapon in our arsenal soon.</end quote></div>
Quite the contrary.
When you perform clinical trials to enable drug approval, there is open dialogue with the FDA. Study designs are reviewed, # of patients recruited is reviewed, etc.
Gilead is no exception.
The FDA went back on their word about Gilead's aztreonam study design, which caused Gilead to have to back track.
The latest posting from Gilead seems fairly promising. I think sometimes when a company is trying to hurry things along, they don't do a very good job of organizing, designing and performing their studies. When this happens, it seems like more time is taken trying to recover and do things the "right" way. It sounds like this will be another weapon in our arsenal soon.</end quote></div>
Quite the contrary.
When you perform clinical trials to enable drug approval, there is open dialogue with the FDA. Study designs are reviewed, # of patients recruited is reviewed, etc.
Gilead is no exception.
The FDA went back on their word about Gilead's aztreonam study design, which caused Gilead to have to back track.
saveferris2009
New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>bkc3</b></i>
The latest posting from Gilead seems fairly promising. I think sometimes when a company is trying to hurry things along, they don't do a very good job of organizing, designing and performing their studies. When this happens, it seems like more time is taken trying to recover and do things the "right" way. It sounds like this will be another weapon in our arsenal soon.</end quote></div>
Quite the contrary.
When you perform clinical trials to enable drug approval, there is open dialogue with the FDA. Study designs are reviewed, # of patients recruited is reviewed, etc.
Gilead is no exception.
The FDA went back on their word about Gilead's aztreonam study design, which caused Gilead to have to back track.
The latest posting from Gilead seems fairly promising. I think sometimes when a company is trying to hurry things along, they don't do a very good job of organizing, designing and performing their studies. When this happens, it seems like more time is taken trying to recover and do things the "right" way. It sounds like this will be another weapon in our arsenal soon.</end quote></div>
Quite the contrary.
When you perform clinical trials to enable drug approval, there is open dialogue with the FDA. Study designs are reviewed, # of patients recruited is reviewed, etc.
Gilead is no exception.
The FDA went back on their word about Gilead's aztreonam study design, which caused Gilead to have to back track.
saveferris2009
New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>bkc3</b></i>
The latest posting from Gilead seems fairly promising. I think sometimes when a company is trying to hurry things along, they don't do a very good job of organizing, designing and performing their studies. When this happens, it seems like more time is taken trying to recover and do things the "right" way. It sounds like this will be another weapon in our arsenal soon.</end quote></div>
Quite the contrary.
When you perform clinical trials to enable drug approval, there is open dialogue with the FDA. Study designs are reviewed, # of patients recruited is reviewed, etc.
Gilead is no exception.
The FDA went back on their word about Gilead's aztreonam study design, which caused Gilead to have to back track.
The latest posting from Gilead seems fairly promising. I think sometimes when a company is trying to hurry things along, they don't do a very good job of organizing, designing and performing their studies. When this happens, it seems like more time is taken trying to recover and do things the "right" way. It sounds like this will be another weapon in our arsenal soon.</end quote></div>
Quite the contrary.
When you perform clinical trials to enable drug approval, there is open dialogue with the FDA. Study designs are reviewed, # of patients recruited is reviewed, etc.
Gilead is no exception.
The FDA went back on their word about Gilead's aztreonam study design, which caused Gilead to have to back track.
saveferris2009
New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>bkc3</b></i>
The latest posting from Gilead seems fairly promising. I think sometimes when a company is trying to hurry things along, they don't do a very good job of organizing, designing and performing their studies. When this happens, it seems like more time is taken trying to recover and do things the "right" way. It sounds like this will be another weapon in our arsenal soon.</end quote>
Quite the contrary.
When you perform clinical trials to enable drug approval, there is open dialogue with the FDA. Study designs are reviewed, # of patients recruited is reviewed, etc.
Gilead is no exception.
The FDA went back on their word about Gilead's aztreonam study design, which caused Gilead to have to back track.
The latest posting from Gilead seems fairly promising. I think sometimes when a company is trying to hurry things along, they don't do a very good job of organizing, designing and performing their studies. When this happens, it seems like more time is taken trying to recover and do things the "right" way. It sounds like this will be another weapon in our arsenal soon.</end quote>
Quite the contrary.
When you perform clinical trials to enable drug approval, there is open dialogue with the FDA. Study designs are reviewed, # of patients recruited is reviewed, etc.
Gilead is no exception.
The FDA went back on their word about Gilead's aztreonam study design, which caused Gilead to have to back track.
saveferris2009
New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>bkc3</b></i>
<br />
<br />The latest posting from Gilead seems fairly promising. I think sometimes when a company is trying to hurry things along, they don't do a very good job of organizing, designing and performing their studies. When this happens, it seems like more time is taken trying to recover and do things the "right" way. It sounds like this will be another weapon in our arsenal soon.</end quote>
<br />
<br />
<br />Quite the contrary.
<br />
<br />When you perform clinical trials to enable drug approval, there is open dialogue with the FDA. Study designs are reviewed, # of patients recruited is reviewed, etc.
<br />
<br />Gilead is no exception.
<br />
<br />The FDA went back on their word about Gilead's aztreonam study design, which caused Gilead to have to back track.
<br />
<br />The latest posting from Gilead seems fairly promising. I think sometimes when a company is trying to hurry things along, they don't do a very good job of organizing, designing and performing their studies. When this happens, it seems like more time is taken trying to recover and do things the "right" way. It sounds like this will be another weapon in our arsenal soon.</end quote>
<br />
<br />
<br />Quite the contrary.
<br />
<br />When you perform clinical trials to enable drug approval, there is open dialogue with the FDA. Study designs are reviewed, # of patients recruited is reviewed, etc.
<br />
<br />Gilead is no exception.
<br />
<br />The FDA went back on their word about Gilead's aztreonam study design, which caused Gilead to have to back track.
The doctor who was reviewing the initial drug study was an EYE doctor... He led the reviewing committee into believing that 7% increase in PFts wasn't important or impressive.... Why? Because he knew nothing about or disease. It sucks, but the deal is, there are a lot of ding-dongs reviewing the studies in the FDA <img src="i/expressions/face-icon-small-wink.gif" border="0">
The doctor who was reviewing the initial drug study was an EYE doctor... He led the reviewing committee into believing that 7% increase in PFts wasn't important or impressive.... Why? Because he knew nothing about or disease. It sucks, but the deal is, there are a lot of ding-dongs reviewing the studies in the FDA <img src="i/expressions/face-icon-small-wink.gif" border="0">
The doctor who was reviewing the initial drug study was an EYE doctor... He led the reviewing committee into believing that 7% increase in PFts wasn't important or impressive.... Why? Because he knew nothing about or disease. It sucks, but the deal is, there are a lot of ding-dongs reviewing the studies in the FDA <img src="i/expressions/face-icon-small-wink.gif" border="0">
The doctor who was reviewing the initial drug study was an EYE doctor... He led the reviewing committee into believing that 7% increase in PFts wasn't important or impressive.... Why? Because he knew nothing about or disease. It sucks, but the deal is, there are a lot of ding-dongs reviewing the studies in the FDA <img src="i/expressions/face-icon-small-wink.gif" border="0">
The doctor who was reviewing the initial drug study was an EYE doctor... He led the reviewing committee into believing that 7% increase in PFts wasn't important or impressive.... Why? Because he knew nothing about or disease. It sucks, but the deal is, there are a lot of ding-dongs reviewing the studies in the FDA <img src="i/expressions/face-icon-small-wink.gif" border="0">
saveferris2009
New member
Well creating a 28 day study and submitting it to the FDA is pretty poor study design - so a 7% increase in FEV1 is only part of the story.
It's tough to assess safety in just 28 days.
But Gilead is sticking to it's story and I know some people inside who say that the FDA told them 28 days was sufficient.
But I agree.... FDA is full of idiots and you can quote me on that.
It's tough to assess safety in just 28 days.
But Gilead is sticking to it's story and I know some people inside who say that the FDA told them 28 days was sufficient.
But I agree.... FDA is full of idiots and you can quote me on that.
saveferris2009
New member
Well creating a 28 day study and submitting it to the FDA is pretty poor study design - so a 7% increase in FEV1 is only part of the story.
It's tough to assess safety in just 28 days.
But Gilead is sticking to it's story and I know some people inside who say that the FDA told them 28 days was sufficient.
But I agree.... FDA is full of idiots and you can quote me on that.
It's tough to assess safety in just 28 days.
But Gilead is sticking to it's story and I know some people inside who say that the FDA told them 28 days was sufficient.
But I agree.... FDA is full of idiots and you can quote me on that.
saveferris2009
New member
Well creating a 28 day study and submitting it to the FDA is pretty poor study design - so a 7% increase in FEV1 is only part of the story.
It's tough to assess safety in just 28 days.
But Gilead is sticking to it's story and I know some people inside who say that the FDA told them 28 days was sufficient.
But I agree.... FDA is full of idiots and you can quote me on that.
It's tough to assess safety in just 28 days.
But Gilead is sticking to it's story and I know some people inside who say that the FDA told them 28 days was sufficient.
But I agree.... FDA is full of idiots and you can quote me on that.
saveferris2009
New member
Well creating a 28 day study and submitting it to the FDA is pretty poor study design - so a 7% increase in FEV1 is only part of the story.
It's tough to assess safety in just 28 days.
But Gilead is sticking to it's story and I know some people inside who say that the FDA told them 28 days was sufficient.
But I agree.... FDA is full of idiots and you can quote me on that.
It's tough to assess safety in just 28 days.
But Gilead is sticking to it's story and I know some people inside who say that the FDA told them 28 days was sufficient.
But I agree.... FDA is full of idiots and you can quote me on that.
saveferris2009
New member
Well creating a 28 day study and submitting it to the FDA is pretty poor study design - so a 7% increase in FEV1 is only part of the story.
<br />
<br />It's tough to assess safety in just 28 days.
<br />
<br />But Gilead is sticking to it's story and I know some people inside who say that the FDA told them 28 days was sufficient.
<br />
<br />But I agree.... FDA is full of idiots and you can quote me on that.
<br />
<br />It's tough to assess safety in just 28 days.
<br />
<br />But Gilead is sticking to it's story and I know some people inside who say that the FDA told them 28 days was sufficient.
<br />
<br />But I agree.... FDA is full of idiots and you can quote me on that.