[MOL] Re: orphan diseases [02812] Medicine On Line


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[MOL] Re: orphan diseases



      I have sent, to date, two other messages concerning this same subject to
your agency, although not to your office, without reply.
            To whom it may concern: I have several questions regarding
exceptions to
regular procedures at your agency. 1: are any of the many forms of cancer
covered by the orphan disease protocol?; 2: can a patient AND his doctor apply
directly to the FDA for treatment with a drug or treatment under the orphan
disease protocol?; 3: can a patient AND his doctor apply for legal access to a
treatment[herceptin] when the patient cannot qualify for the trials currently
being conducted and has exhausted all other treatment options?
      These same questions were posed to you agency approximately one week ago
and I have not yet recieved a reply. You attention is appreciated.

      Sincerely
      William C. Van Buskirk[WmCVB@aol.com] 
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