musclemania70
New member
expected approval date for 661 is 2020
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musclemania70
New member
expected approval date for 661 is 2020
M
moxie1
Guest
2020?????
That is really NOT cool. <img src="i/expressions/face-icon-small-sad.gif" border="0">
That is really NOT cool. <img src="i/expressions/face-icon-small-sad.gif" border="0">
M
moxie1
Guest
2020?????
That is really NOT cool. <img src="i/expressions/face-icon-small-sad.gif" border="0">
That is really NOT cool. <img src="i/expressions/face-icon-small-sad.gif" border="0">
Incomudrox
New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>musclemania70</b></i> expected approval date for 661 is 2020</end quote>
Source?
Source?
Incomudrox
New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>musclemania70</b></i> expected approval date for 661 is 2020</end quote>
Source?
Source?
saveferris2009
New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>chroma7</b></i> most drugs get approved in phase 4. 770 got approved in phase 3. p.</end quote>
No, all drugs are required to go through 3 phases of clinical trials.
From the FDA's website. As you can see, Phase IV is post-marketing study aka, after the drug has been FDA approved and hit the market:
<a class="header2" name="Q19"></a>What are the phases of clinical trials?<span>Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phasel">Phase I trials</a><span>, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phasell">Phase II trials</a><span>, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phaselll">Phase III trials</a><span>, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phaselv">Phase IV trials</a><span>, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
Source:<a href="http://clinicaltrials.gov/ct2/info/understand">http://clinicaltrials.gov/ct2/info/understand</a>
No, all drugs are required to go through 3 phases of clinical trials.
From the FDA's website. As you can see, Phase IV is post-marketing study aka, after the drug has been FDA approved and hit the market:
<a class="header2" name="Q19"></a>What are the phases of clinical trials?<span>Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phasel">Phase I trials</a><span>, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phasell">Phase II trials</a><span>, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phaselll">Phase III trials</a><span>, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phaselv">Phase IV trials</a><span>, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
Source:<a href="http://clinicaltrials.gov/ct2/info/understand">http://clinicaltrials.gov/ct2/info/understand</a>
saveferris2009
New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>chroma7</b></i> most drugs get approved in phase 4. 770 got approved in phase 3. p.</end quote>
No, all drugs are required to go through 3 phases of clinical trials.
From the FDA's website. As you can see, Phase IV is post-marketing study aka, after the drug has been FDA approved and hit the market:
<a class="header2" name="Q19"></a>What are the phases of clinical trials?<span>Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phasel">Phase I trials</a><span>, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phasell">Phase II trials</a><span>, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phaselll">Phase III trials</a><span>, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phaselv">Phase IV trials</a><span>, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
Source:<a href="http://clinicaltrials.gov/ct2/info/understand">http://clinicaltrials.gov/ct2/info/understand</a>
No, all drugs are required to go through 3 phases of clinical trials.
From the FDA's website. As you can see, Phase IV is post-marketing study aka, after the drug has been FDA approved and hit the market:
<a class="header2" name="Q19"></a>What are the phases of clinical trials?<span>Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phasel">Phase I trials</a><span>, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phasell">Phase II trials</a><span>, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phaselll">Phase III trials</a><span>, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.<span>In<a href="http://clinicaltrials.gov/ct2/info/glossary#phaselv">Phase IV trials</a><span>, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
Source:<a href="http://clinicaltrials.gov/ct2/info/understand">http://clinicaltrials.gov/ct2/info/understand</a>
C
cfsucks
Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Incomudrox</b></i> <div class="FTQUOTE"><begin quote><i>Originally posted by: <b>musclemania70</b></i> expected approval date for 661 is 2020</end quote> Source?</end quote>
+1 wondering where you heard this
+1 wondering where you heard this
C
cfsucks
Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>Incomudrox</b></i> <div class="FTQUOTE"><begin quote><i>Originally posted by: <b>musclemania70</b></i> expected approval date for 661 is 2020</end quote> Source?</end quote>
+1 wondering where you heard this
+1 wondering where you heard this
C
cfsucks
Guest
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From the link above<strong>:</strong>
<h6 class="uiStreamMessage" style="text-align: left;" data-ft="{"><span class="messageBody" data-ft="{"><strong class="messageBody" data-ft="{">They gave a timeline- 2014 Ataluren, 2015 add in other mutations that can take Kalydeco - effects 15-20% population, 2016 Combo drug potentiall approved with 50-90% population effected, 2020- work on next generation drugs- like making the previous mentioned better.</strong> They noted now- or in the past- a cf patient by age 30 likely needing lung transplant. NOW - anticipate age 60- doing well with less than 1-2%/yr decrease lung function, with these super drugs- expect to be running road races at age 60 and beyond as if don't have CF! Rambling note but wanted to share.</h6>
<strong></strong>
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<h6 class="uiStreamMessage" style="text-align: left;" data-ft="{"><span class="messageBody" data-ft="{"><strong class="messageBody" data-ft="{"></strong></h6>
From the link above<strong>:</strong>
<h6 class="uiStreamMessage" style="text-align: left;" data-ft="{"><span class="messageBody" data-ft="{"><strong class="messageBody" data-ft="{">They gave a timeline- 2014 Ataluren, 2015 add in other mutations that can take Kalydeco - effects 15-20% population, 2016 Combo drug potentiall approved with 50-90% population effected, 2020- work on next generation drugs- like making the previous mentioned better.</strong> They noted now- or in the past- a cf patient by age 30 likely needing lung transplant. NOW - anticipate age 60- doing well with less than 1-2%/yr decrease lung function, with these super drugs- expect to be running road races at age 60 and beyond as if don't have CF! Rambling note but wanted to share.</h6>
<strong></strong>
C
cfsucks
Guest
<h6 class="uiStreamMessage" style="text-align: left;" data-ft="{"><span class="messageBody" data-ft="{"><strong class="messageBody" data-ft="{"></strong></h6>
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<h6 class="uiStreamMessage" style="text-align: left;" data-ft="{"><span class="messageBody" data-ft="{"><strong class="messageBody" data-ft="{"></strong></h6>
From the link above<strong>:</strong>
<h6 class="uiStreamMessage" style="text-align: left;" data-ft="{"><span class="messageBody" data-ft="{"><strong class="messageBody" data-ft="{">They gave a timeline- 2014 Ataluren, 2015 add in other mutations that can take Kalydeco - effects 15-20% population, 2016 Combo drug potentiall approved with 50-90% population effected, 2020- work on next generation drugs- like making the previous mentioned better.</strong> They noted now- or in the past- a cf patient by age 30 likely needing lung transplant. NOW - anticipate age 60- doing well with less than 1-2%/yr decrease lung function, with these super drugs- expect to be running road races at age 60 and beyond as if don't have CF! Rambling note but wanted to share.</h6>
<strong></strong>
<h6 class="uiStreamMessage" style="text-align: left;" data-ft="{"><span class="messageBody" data-ft="{"><strong class="messageBody" data-ft="{"></strong></h6>
<h6 class="uiStreamMessage" style="text-align: left;" data-ft="{"><span class="messageBody" data-ft="{"><strong class="messageBody" data-ft="{"></strong></h6>
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<h6 class="uiStreamMessage" style="text-align: left;" data-ft="{"><span class="messageBody" data-ft="{"><strong class="messageBody" data-ft="{"></strong></h6>
From the link above<strong>:</strong>
<h6 class="uiStreamMessage" style="text-align: left;" data-ft="{"><span class="messageBody" data-ft="{"><strong class="messageBody" data-ft="{">They gave a timeline- 2014 Ataluren, 2015 add in other mutations that can take Kalydeco - effects 15-20% population, 2016 Combo drug potentiall approved with 50-90% population effected, 2020- work on next generation drugs- like making the previous mentioned better.</strong> They noted now- or in the past- a cf patient by age 30 likely needing lung transplant. NOW - anticipate age 60- doing well with less than 1-2%/yr decrease lung function, with these super drugs- expect to be running road races at age 60 and beyond as if don't have CF! Rambling note but wanted to share.</h6>
<strong></strong>
C
cfsucks
Guest
<div class="FTQUOTE"><begin quote><em>Originally posted by: <strong>mom2JD</strong></em> amazing results here after 2 weeks http://www.cfgirlseyeofthetiger.com/blog/2012/03/20/Halfway-through-.aspx </end quote>
that is amazing- can these drugs not be fast tracked ahah- like put them out now lol! the number of lives that could be saved would be unimaginable!
that is amazing- can these drugs not be fast tracked ahah- like put them out now lol! the number of lives that could be saved would be unimaginable!
C
cfsucks
Guest
<div class="FTQUOTE"><begin quote><em>Originally posted by: <strong>mom2JD</strong></em> amazing results here after 2 weeks http://www.cfgirlseyeofthetiger.com/blog/2012/03/20/Halfway-through-.aspx </end quote>
that is amazing- can these drugs not be fast tracked ahah- like put them out now lol! the number of lives that could be saved would be unimaginable!
that is amazing- can these drugs not be fast tracked ahah- like put them out now lol! the number of lives that could be saved would be unimaginable!