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