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29837 tn?1414538248

Just Spoke To Vertex

I have a contact at Vertex. We spoke at length about Telepravir and the "compassionate" use. That means use now (without placebo) for Cirrhotic victims. While he couldn't give me a definite time line for the compassionate release, he did say that telepravir being in Phase III, they are seeking approval by the FDA in the second half of 2010, and making it available through prescription instead of the current clinical trials.

Interestingly, he added a comment that we could hopefully expedite the "compassionate" use approval by the FDA if we write them an email stating the urgency for those who need this NOW.

Here is a direct link, with phone number to the FDA: http://www.fda.gov/comments.html

Write to them and continue to bombard them with emails until they give in. This is a battle to be sure, but if the government sees that we are desperately seeking a compassionate release of Telepravir, they could rethink this whole matter. Write an email now...

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74 Responses
Avatar universal
Consider it done, and we should do it daily.
29837 tn?1414538248

Here is a direct link to the email page...

http://www.fda.gov/cder/comment.htm

Magnum
Avatar universal
thats a great idea.
my first email is going out today
96938 tn?1189803458
Real letters could be more impactful, copying a federal legislator.  Ask for a letter back in reply.  Then follow-up with phone calls to the person who writes back.  Then, repeat...and repeat
29837 tn?1414538248
Here is the email I just sent:

Regarding the Vertex drug Telepravir (VX-950) for the treatment of Hepatitis C patients, I want to add that many of us are in Cirrhosis and need this new drug NOW!

You MUST release it for “compassionate” use to us who are dying, and not force us to attend clinical trials and possibly get placebos. This is our last hope. The alternative? To burden the Medicare system with the high cost of liver transplants.

The Telepravir drug is now in phase 3 (the final phase) and has shown remarkable abilities to clear this virus and allow the liver to regenerate.

We are willing to risk it even though phase 3 has not completed. As for all the literature and clinical trials results, the risk seems non-existent for toxicity . We are the people, and as Lincoln stated in the Gettysburg address, "and the government of the people, by the people, for the people, shall not perish from the earth".

Please listen to us people and rethink this as soon as possible. Many lives could be saved NOW...
Avatar universal
Well, my letter was no where near eloquently stated as yours, but I sent one.  I also requested a reply.

I think FI guy has a good point about real letters and will write one of those also.
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