Bad news from Vertex

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musclemania70

New member
one way or another we won't know more until it is published by Vertex in writing.
We're in the dark until they publicize the data and tell us all what the &8LL is going on.
 
M

musclemania70

New member
one way or another we won't know more until it is published by Vertex in writing.
We're in the dark until they publicize the data and tell us all what the &8LL is going on.
 
H

hmw

New member
I agree!!!! I just wish they would give us a press release- the info has been gathered and examined and turned inside out by now without a doubt.

These 'sources' at CFF and Vertex and even drs at some centers, according to who you ask all around the cf community are leaking all kinds of stuff, and not only is it causing confusion, but depending on who hears it, it can also cause the spread of a fair amount of MISinformation since once something is repeated things get lost in the translation and/or the emotions of the repeaters starts getting mixed in jussssst a bit and no one has anything official to refer to as the real deal.
 
H

hmw

New member
I agree!!!! I just wish they would give us a press release- the info has been gathered and examined and turned inside out by now without a doubt.

These 'sources' at CFF and Vertex and even drs at some centers, according to who you ask all around the cf community are leaking all kinds of stuff, and not only is it causing confusion, but depending on who hears it, it can also cause the spread of a fair amount of MISinformation since once something is repeated things get lost in the translation and/or the emotions of the repeaters starts getting mixed in jussssst a bit and no one has anything official to refer to as the real deal.
 
S

stranger

Guest
It may be comparing apples w oranges when talking time scale of 770 approval v. potential approval dates for 661 (assuming the results pan out). As the FDA themsleves pointed out, Kalydeco is the first to be put into a new bucket now called 'personalized medicine.' So, looks like VRTX has greater experience now then they did in 2008, would we all agree? Check. Looks like the FDA is ready, willing and able to fast-track something that 'looks' like this (ie, there is a precedent). Check. I am of the opinion that there are two areas that need laser focus to bring 661 (pending results) to market prior to 2016; one, those on 770... go back and add up what the insurance outlay was for your care three years prior to going on Kalydeco. Come up with a 'per year' avg. Now, keep track of the same data while being on Kalydeco. Compare.
Second -- WORK WITH FOUNDATION -- BECOME AN ADVOCATE -- DON'T LET ANYONE INTERRUPT HOW THE FDA IS GETTING FUNDED. We now have a function machine (VRTX > FDA > Market) that is 'working;' 'change' to the FDA can have a detrimental effect on how this 'function' machine works.
 
S

stranger

Guest
It may be comparing apples w oranges when talking time scale of 770 approval v. potential approval dates for 661 (assuming the results pan out). As the FDA themsleves pointed out, Kalydeco is the first to be put into a new bucket now called 'personalized medicine.' So, looks like VRTX has greater experience now then they did in 2008, would we all agree? Check. Looks like the FDA is ready, willing and able to fast-track something that 'looks' like this (ie, there is a precedent). Check. I am of the opinion that there are two areas that need laser focus to bring 661 (pending results) to market prior to 2016; one, those on 770... go back and add up what the insurance outlay was for your care three years prior to going on Kalydeco. Come up with a 'per year' avg. Now, keep track of the same data while being on Kalydeco. Compare.
Second -- WORK WITH FOUNDATION -- BECOME AN ADVOCATE -- DON'T LET ANYONE INTERRUPT HOW THE FDA IS GETTING FUNDED. We now have a function machine (VRTX > FDA > Market) that is 'working;' 'change' to the FDA can have a detrimental effect on how this 'function' machine works.
 
S

stranger

Guest
same Stranger - different post...
661 and the way it has been explained to me (also a nobody)...
for both copies of the DF508, imagine there is a quality control agent (for the younger ones in the crowd -- the bouncer outside the door at the hottest club in town...). Ppl with full functioning CFTR's are the hot chicks in the queue who get right in no problem, even though there is a line two hours long (quit bragging - you know who you are!). For those with both copies, the bouncer is not letting us in because we don't 'look' the part; we have money in our wallets and love the hip music, but our shirts aren't tucked in... we showed up in sneakers... they see we have Spandau Ballet on our iPODs, etc. There is no way into the club!
661 taps the bouncer on the shoulder, he looks the other way, so we can get in! some of us, there is a theory, have credit cards with no limits (think of this as the chloride channels working just fine...). If *some* of the folks get past the bouncer (the protein makes it to the top of the cell) and you have no credit on your credit cards (chloride channels not functioning as advertised) then 770 OR SOMETHING LIKE 770 has to quickly call the bank and extend your credit.

For the record, it wasn't explained to me like a night of clubbing and dancing with no worries, but it kinda left my fingertips like that... maybe because i so desperately want this to work so we CAN ALL GO OUT CLUBBING, for real, WITH NO WORRIES, DANCING AND DANCING, with lots of breaths and of course, no Spandau Ballet...

*sorry for those of you who did a search on 'Spandau Ballet' and ended up here; look away; nothing to see here!
 
S

stranger

Guest
same Stranger - different post...
661 and the way it has been explained to me (also a nobody)...
for both copies of the DF508, imagine there is a quality control agent (for the younger ones in the crowd -- the bouncer outside the door at the hottest club in town...). Ppl with full functioning CFTR's are the hot chicks in the queue who get right in no problem, even though there is a line two hours long (quit bragging - you know who you are!). For those with both copies, the bouncer is not letting us in because we don't 'look' the part; we have money in our wallets and love the hip music, but our shirts aren't tucked in... we showed up in sneakers... they see we have Spandau Ballet on our iPODs, etc. There is no way into the club!
661 taps the bouncer on the shoulder, he looks the other way, so we can get in! some of us, there is a theory, have credit cards with no limits (think of this as the chloride channels working just fine...). If *some* of the folks get past the bouncer (the protein makes it to the top of the cell) and you have no credit on your credit cards (chloride channels not functioning as advertised) then 770 OR SOMETHING LIKE 770 has to quickly call the bank and extend your credit.

For the record, it wasn't explained to me like a night of clubbing and dancing with no worries, but it kinda left my fingertips like that... maybe because i so desperately want this to work so we CAN ALL GO OUT CLUBBING, for real, WITH NO WORRIES, DANCING AND DANCING, with lots of breaths and of course, no Spandau Ballet...

*sorry for those of you who did a search on 'Spandau Ballet' and ended up here; look away; nothing to see here!
 
I

inna1977

New member
Here is a blog from someone on 770/661 trial and she is doing amazing.

http://www.cfgirlseyeofthetiger.com/blog/2012/03/20/Halfway-through-.aspx
 
I

inna1977

New member
Here is a blog from someone on 770/661 trial and she is doing amazing.

http://www.cfgirlseyeofthetiger.com/blog/2012/03/20/Halfway-through-.aspx
 
A

Anomie

New member
Ya but that could change here in the near future. Does anybody know if the rumor is true that they changed the vx-809 trial to include DF508 heterozytes because the drug wasn't being successful enough on the double deltas and they wanted to see if it would work on other mutations?
 
A

Anomie

New member
Ya but that could change here in the near future. Does anybody know if the rumor is true that they changed the vx-809 trial to include DF508 heterozytes because the drug wasn't being successful enough on the double deltas and they wanted to see if it would work on other mutations?
 
M

MamatoAlexa

New member
Just wanted to jump in and say I am in Chohort 2 of the 809/770 study, looking at higher doses of 809. I am DDF508. I took 809 or placebo for one month and then added 770 or placebo a month later. I am three weeks into taking the combo. Sadly, next Monday I will take my last dose of meds along with a second very involved 48 hours study visit.
This study is still very much going on and they certainly do not have all of the data collected yet.
 
M

MamatoAlexa

New member
Just wanted to jump in and say I am in Chohort 2 of the 809/770 study, looking at higher doses of 809. I am DDF508. I took 809 or placebo for one month and then added 770 or placebo a month later. I am three weeks into taking the combo. Sadly, next Monday I will take my last dose of meds along with a second very involved 48 hours study visit.
This study is still very much going on and they certainly do not have all of the data collected yet.
 
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