I think the problem is they made money on the rumor and that is good enough. Their data seems to good not to allow this the only thing it can be is greed. Same thing for everthing else. I hope my liver lasts untill they get this out. I relasped after 72 week treatment and no detectable virus at end(below 5IU). Maybe it does not work when you have late stage
liver disease and they want to keep it secret. As for drug companies they get alot of funding from goverment directly and indirectly so the comment about cure yourself is inappropriate. Fingers Crossed!!
I'm sorry Mag it was looking promising for a little while there i thought. One of them will break soon and you will get it - just try to hang on, god it's got to be so hard on you but if anybody can do it I know it's you.
deb
Does anybody know how long it takes to get a drug approved by the FDA even if they are trying to fast track?
"As for drug companies they get alot of funding from goverment directly and indirectly so the comment about cure yourself is inappropriate. Fingers Crossed!!
Its the way around my friend,drug compaines fund govts
As someone who is waiting for this tx to be approved I appreciate you posting, I relapsed with Roch 1626, responded by 8th week so I hope this new tx will help me. I am starting to have new extra hepatic symptoms and sure could use the help.
My liver doc said that it would hopefully be out in 2011 and that people might not have to treat as long, could even be 24 weeks, his words. I, myself, after the hell I went through on the last tx, would treat as long as possible to kill this virus and the cryoglobulins I want to get better, like I was before treatment. I felt fine before tx, it has been a year and 5 months since last tx and I am just starting to feel normal. 24 weeks sound nice but as a 1a I know I need to treat longer.
Thank you again
D
I'm sorry to hear this response, Maybe you should try Merck also.
It makes me so angry that these sh!ts are sitting on a drug which is needed desperately to save lives. I think they are using people like you to put pressure on the FDA to get faster approval.
While I feel like cursing them for their ethics / morality, I am going to restrain myself because at the end of the day this drug will improve the cure rate for hepC sufferers and that is a good thing. They never claimed to be Mother Teresa.
Thanks for getting this information for us. Hang in there,
dointime
one of the fastest FDA approvals ever was for peg-interferon - 42 days. of course that was just a new formulation for an approved compound for HCV. Other fast approvals occurred with HIV drugs in the 90's. apparently unmet need is a motivator for the FDA. I think it could go pretty quick if vertex has its act together. certainly by the end of 2011 if vertex gets all the necessary info to the FDA by the end of this year.
Pretty angry to hear this news, why expanded access for HIV and not HEP C ? My consultant has been inferring that EA was quite possible. Guess he was wrong.
Magnum,
I am sorry to hear that your request was denied. At least you tried. Thank you for sharing this with all of us.
All,
I think expanded access is possible. I also think individual patient INDs are possible in spite of what has happened to Magnum. If we are not satisfied with how this plays out in the coming months, then we can submit another 200 individual patient IND applications.
PS
Vertex may prefer to complete the REALIZE clinical trial before releasing telaprevir. REALIZE has about 650 patients – all non-responders. One arm adds an IFN/RBV lead-in phase. Two telaprevir arms include 48 months of INF/RBV, because in PROVE3 this duration got better results. Results from REALIZE will help guide our physicians on how best to administer these drugs. There will be more data on drug resistance and what real risks they might pose. Data should be available in the July-September time period. I know it is hard to wait. I have been waiting for 20 years.
I am glad you are sharing your interaction with Vertex. It is unfortunate that they are not willing to go with compassionate use. I don't understand what they have to lose, except that they may not be in the position right now to manufacture and market.
If I recall, reading from the investor news, Vertex, unlike other R&D companies wants to retain Telaprevir and market it itself. Most R&D companies would be looking for a buyer fairly soon. So I wonder if that factors into their decision not to help relapsers right now.
Hopefully you ( and the rest of us relapsers) will not have too long to wait.
frijole
FRIJOLE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
You just made my day chickie, seeing your name really put a smile on my face! :)
That sukks, I'm sorry they turned you down!
Hugs, Marcia