Dear Dr. Woodcock: Since we have now surpassed five months since Lotronex has been removed from the market, our frustration with this issue has increased exponentially. The only affective medicine for many of us is not available and, thus, the lack of availability has caused severe, undue hardship. To date, the Lotronex Action Group has yet to receive data from the FDA showing Lotronex causes adverse side affects more frequently than the average prescription medicine, when properly prescribed and taken. Therefore, it is questionable whether the medicine was removed purely because of data or from perception that the related illness is not severe enough to warrant the potential for adverse side affects. As the FDA and GlaxoSmithKline have stated that they understand the severity of the illness and that talks are currently ongoing, once again, we respectfully request Lotronex be made available as soon as possible. It has been five months. That is five months that thousands of people have needlessly suffered from abdominal pain, severe diarrhea, depression, social anxiety and a variety of other related symptoms. The Lotronex Action Group has submitted a formal petition to the head of the FDA and, as of yet, has not heard a response. It is our hope the FDA and GSK are working diligently on the resolution of this issue. The LAG requests that a schedule be developed, if not already, with milestone dates established to nsure progress on the resolution of the issue. The LAG also requests that this issue be fast tracked and resolved in the immediate future (ie...one or two months). We will be contacting GSK and requesting the same. Moreover, it is our hope that if and/ or when the medicine is brought back to the market, it is accessible to those previously taking it without excessive burden. As by now, we all know more about this medicine than we ever wanted to. Sincerely, The Lotronex Action Group Tom Bell, Coordinator Richard Fireman, Coordinator Corey Miller, Coordinator In Partnership with the IBSGroup Jeffrey Roberts, President