I keep a notebook titled " FDA Blocks Life saving Drug ". You may already do the same. helps me to jot down chronological delays due to FDA , and includes the other " players " in this System, including Genentech , Partners IRB , Congress, Media, Doctors, Big Advocacy , etc. Focus on This FDA, who talks with you , who refuses to ( the decision-makers ), etc. For a future reckoning, perhaps via Sen Hagan , others.
Most importantly , we went through a similar crazy few weeks in 2010 , thankfully our doc was completely in our corner, ( once she saw we wrer comitted enough to go Va. just for enrollment ) giving low dose adria, considered tyk too, checking labs like white count , LFT's etc. every week, to get Lorraines counts up to standards, right up to the 2 week washout that exp access required . be assertive , politely question EVERYTHING , i. e. what is their expected washout time frame ? , etc. I personally would think it mimics exp access , 2 weeks. Be the " squeaky wheel ". e-mail me at
pmccartinjr@comcast.net , if you want. we can talk.