North American Vaccine Message Board

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Biotech / Medical : North American Vaccine

NVX 1.110

-0.9%

Jan 23 9:30 AM EST

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To: Don W Stone who wrote (234)	1/23/1998 5:52:00 PM
From: Don W Stone	Read Replies (1) of 507

The Company press release of Jan 9, 1998. THIS WAS A VERY CAREFULLY THOUGHT OUT NEWS RELEASE. Well worth reading and rereading I was told by a Company spokesmen that the wording had the approval of the FDA lawyers. The company spokesmen said that he considered it very positive. Since than i have found most whom I talk to consider it positive. ( of course they are all long the stock) Here are the significant statements: 1)"NVX announced today that it has been advised by the FDA that CERTIVA is on ther final track for completing the final steps for licensure." 2)"This information was conveyed to the Company at a meeting held with FDA officials this week." 3) " At that meeting the FDA expressed its objective of promply completing the review process for CERTIVA." 4)"Towards this end, the FDA has requested additional information which the Company intends to submit shortly." and 5) "Based on its meeting with the FDA, the Company anticipates that the regulatory review process could be completed during the first quarter of 1998 or shortly thereafter." My comment: This is the FDA advising NVX of the status of their obtaining licensure for CERTIVA and expressing their objective to promply complete the process. The FDA asked for the information they need to finish up promply. NVX says they will submit the information shortly. A Company spokesmen told me that would all happen within 2 weeks. So when will we see approval? The same press release says it is dependent on a) providing the information requested in a timely manner. b) the acceptability of the information, and c) the time it takes the FDA to complete the review process. NVX also stresses that the regulatory review of a vaccine product is an ongoing, interactive process. Right now i am assuming that the information has been submitted, and some interaction is going on,that is about it. If on first pass it is acceptable than who knows: Certainly if we hadn't had our hopes set for end of the year this would be all POSITIVE. The FDA is saying CERTIVA is "ON TRACK FOR LICENSURE" No way would the FDA make that statement if they thought there was a chance that they would not approve CERTIVA. NOW THAT LATTER STATEMENT IS MY INTERPRETATION. PATIENCE. "

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