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Biotech / Medical : VICL (Vical Labs)
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To: bob zagorin who wrote (1298)8/3/2000 1:25:01 AM
From: Tagore  Read Replies (1) of 1972
 
Given the death of the young man in the Penn trials, I am assuming that the FDA will require an extremely high hurdle for the viral vectors, especially since they know of the existence of naked gene therapy. Vical has a good relationship with the FDA because of their care in their trials and their safety record. The principal reason that Merck went with Vical was to avoid the complications with the viral vectors which include the possibility of the reactivation of the virus or the body's immune system reacting to the viral vector in ways detrimental to the patient. This is why HGSI, Aventis and Centacor (now J&J went with Vical). This is why many other companies will follow suit. I believe that there will be a place for viral vectors in the future but the FDA will have to have a lot of experience with them first. Moreover, I believe that the FDA will wait and see how the naked gene therapy works before going on to the viral vectors. All of this is just my opinion and more knowledgeable people may have much to add.
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