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News
02/06/01 - LAG
Coordinators to Ramona Dubose, GlaxoSmithKline
The Lotronex Action Group
Ramona Dubose, Manager, Production Communications
GlaxoSmithKline
Room D-320
Five Moore Drive
Research Triangle Park, N.C. 27709
February 6, 2001
Dear Ramona Dubose:
The Lotronex Action Group (LAG), comprised of several hundred former users of Lotronex who have benefited significantly from the medicine, is hereby
requesting GlaxoSmithKline allow the LAG coordinators to participate in negotiations between GSK and the FDA involving the return of Lotronex to the
marketplace. As both GSK and the LAG share the same ultimate goal for continued
marketing of Lotronex with the least restrictions possible, we feel the LAG can be helpful in demonstrating to the FDA that the medicine provides substantial
benefit.
The LAG also has a variety of concerns which we would like to address directly
with both parties as we are the users of the medicine. Moreover, we are concerned that the user base has not been contacted by the FDA or GSK to
determine if the user's knew of the risks of adverse side affects prior to taking the medicine, what dosages the medicine is being taken in and how the
medicine has benefited men.
The Lotronex Action Group feels we can be of great assistance to
GlaxoSmithKline in working expeditiously with the FDA to find an
acceptable agreement on how the medicine can be dispensed. Moreover, we would appreciate your cooperation in allowing our participation as
we are an independent group with no agenda other than the return of the medicine to the market.
Sincerely,
The Lotronex Action Group
Tom Bell, Coordinator
Richard Fireman, Coordinator
Corey Miller, Coordinator
In Partnership with the IBSGroup
Jeffrey Roberts, President
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