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Biotech / Medical : Aviron -- Ignore unavailable to you. Want to Upgrade?

To: mauser96 who wrote (354)	9/2/1998 5:07:00 PM
From: Arthur Radley	Read Replies (1) \| Respond to of 645

Excellent description of the issue at hand. With this novel delivery system, I guess we should have expected that the FDA would make sure of the purity of the manufacturing process. Again, and if I'm wrong please correct me, the current plant manufacturing this drug for AVIR is located in Europe. Not to say that Europeans would not have safety concerns, it behooves the FDA to make sure that any drug with this much potential of use, would be extra cautious in the manufacturing approval process that is part of any NDA application. Normally I would say this is a once in a life time buying opportunity for a new drug with great potential, but the overall market conditions give me pause. Hard to believe that AVIR is down nearly 2/3rds in the past few weeks.

To: mauser96 who wrote (354)	9/3/1998 1:50:00 AM
From: Mel Kaplan	Read Replies (1) \| Respond to of 645

Lucius, You may be aware that the plan for the nasal instillation is to use live attenuated virus vaccine for the children population and heat-killed virus vaccine for aged populations, Presumably, this represents a concern for the higher incidence of relatively immunodeficient individuals among the elderly, and the risk of clinical infection using live virus, even if attenuated, in this population. In the original article in the NEJM, it was reported that in a few children, a transient fever occurred in the week after nasal instillation. This was considered inconsequential though unexplained. All of the above is to emphasize the importance of careful quality control of the vaccine mixtures used and of clinical monitoring for reactions or infection. As you point out, children may exhibit immunodeficient states on a genetic or physiologic basis. Appreciated your note. Mel