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29837 tn?1414534648

FDA Answers

As you may know, I'm relentless in my effort to get the PI's out ASAP. Today I got not one but two calls from the FDA, so apparently my persistence is paying off. They are going to do whatever the pharmaceutical companies suggest, especially since there are no other alternative drugs except Interferon and Ribavirin.

My contact at Vertex, who I just spoke to, is going to look once more into the IND application (Compassionate Use), and see if there's been any changes in their (Vertex) policy for allowing it. If some of you recall, about 2 years ago, my doctor applied for the IND and was refused by Vertex. Now? That's what my contact will find out. The compassionate use if for those who can't wait and who's doctor (such as in my case), suggests immediate treatment so as not to allow the disease to progress.

I will receive an answer from Vertex today or Monday and will pass on the information. My point here is that the pressure on the FDA is working because of the returned phone calls. I will keep up the pressure with both the FDA and Vertex. I can't fight this alone, so I can use all the help I can in the pressure department...

Magnum
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Avatar universal
I'm praying for your success.  And I'll find the numbers you've posted and add my voice.  
For good measure, my fingers are crossed.

Carol
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Avatar universal
I think it's our responsibility to help our friends who have very seriously advanced disease by calling whoever they ask us to call in the fda or drug companies. We could be the ones who are in the same situation soon also.

I remember when when people were dropping so quickly from aids what an uproar occured in the infected community, and how politically motivated they became and how much pressure was put on the government to act. They got results finally from their actions.

The hiv community was very cohesive, and because a lot of the people were gay (of course I realize not nearly all) who were getting the disease early on there was already a common emotional and political bond with the infected that helped them to act as one.

i wish we had that same cohesiveness and ability to apply pressure to the right people. It's not that difficult to make a phone call or send an email.

- Dave

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29837 tn?1414534648
I just got a call from my contact at Merck. Unfortunately, the company is refusing to bend on the "compassionate use" issue. This means we have to keep working on the FDA to make sure they put these PI drugs on a fast-track.

I have yet another contact to call and put some pressure on to make sure they (FDA) don't forget our plight. If your life is worth saving, I can use all the help in pushing this issue so the drugs will be released the first half of 2011 not the end of 2011 or in 2012.
Magnum
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