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Biotech / Medical : VD's Model Portfolio & Discussion Thread
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To: Andrew H who wrote (1909)8/5/1997 11:59:00 AM
From: Richard Belanger   of 9719
 
Andy - FWIW, I don't follow CYTO but noted the concern in the letter regarding radioisotope licenses. I don't know the history or details of this issue, but I do know something about licenses. I would guess that the majority of facilities that would use this product already have a radioactive material license. They would, however, have to amend the license to specifically authorize the product. If time and patient care is of the essence, usually the applicant can work with the regulatory agency (either State or Nuclear Regulatory Commission, depending on home state) to get an expedited review/approval. I have obtained such amendments in a matter of a few days (in California). On the other hand, if the facility does not have an existing radioactive materials license, 8 weeks is a real pipedream for first-time application/review/approval. Hope this helps.

Rich
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