NORTH AMERICAN VACCINE (NVX) Message Board

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Biotech / Medical : NORTH AMERICAN VACCINE (NVX)

NVX 1.510

-3.8%

Oct 31 9:30 AM EST

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To: James Baker who wrote (17)	1/10/1998 7:45:00 AM
From: Don W Stone	Read Replies (2) of 21

James Baker: This is ONE BIG STEP FORWARD. Although your reaction is not surprising. The news doesn't fit our expectations. Ug! We all wanted and were expecting FDA approval now. What we got was a status report which is very POSITIVE. This licensure process is an interactive one. The Company and the FDA go back and forth. I do think the Company does want a lot more than just an FDA approval. After all it is this process that ends out dictating what a comapany can say about their product in any promotion or marketing effort. To NVX this i would think is high priority. They have submitted plenty of data on clinical trials and post martketing studies to show that they have the safest vaccine. The only one thatcan say that. Now I would think they want to be able to broadcast that to the world. If it takes a little more convincing on their part , like submit more information that they have but hasn't been requested to this point, I'd say go for it. Now that is conjecture on my part but that is the only thing that makes sence to me. This is what I have been saying in many of my earlier post. I think you are aware of how the FDA tracks what Companies say or advertise about their products. They are the watchdog. If a company is saying more than what was decided to be the " LABEL" the FDA will site them. I am sure you have seen incidents of this in the news. When Lederle and Connaught went up for approval to use their existing DTaP vaccine for infants what they got for "Labeling" wasn't going to make alot of difference. I don't think anyone here could tell the difference in those two vaccines. Now bring up CERTIVA. There is a difference. A BIG DIFFERENCE. I would say that the competition and NVX can all say that they are SAFER than the old wholecell pertussis vaccines with rare occurences of serious adverse events. Big deal. NVX should be able to say that there have been no occurence of serious adverse events associated with CERTIVA. Well I am going ahead on that assumption ad if I am right the reward will just be that much bigger. THIS NEWS JUST COULD BE ONE BIG LEAP FORWARD. :-}, :-}

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