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: Don W Stone who wrote (18)	1/11/1998 9:33:00 AM
From: Don W Stone	of 21

Discard EMOTIONS, THINK POSITIVE Thank goodness this press release came out on friday at the close. Emotions are beginning to be replaced with thought. What was negative news on friday is now appearing to be interpreted for what it should be. "One big step forward". For those that would like to see it that way maybe this will help. I was so disappointed when I got the news on friday that I viewed it as all bad. Now I recognize that if I had no expectations of FDA approval being imminent I would have interpreted the news for what it really was. A POSITIVE event. This is the first status report we have had on the FDA approval process for CERTIVA. I spoke to the Company on friday and was told that the wording of this press release was agreed to by the FDA before it was sent out on friday. Now here is the Headline; " North American Vaccine Advised by the FDA that CERTIVA is on Track for Completing Final Steps for Licenture". HOw can that be interpreted as anything but extremely POSITIVE. The answer is it can't unless one overlays it with what they were expecting which was APPROVAL and then it is a disappointment to them at this time. NOw disappointment doesn't make it negative news. The other point that seems to be taken as negative news is the FDA requesting additional information. Here I'll admit such request can be negative. How negative depends on what is being requested. 1) If it is for information that one can't provide and that is why it hasn't already been provides that is negative. If the information that the FDA request can't be provided odds are you aren't going to get approval.:-{ 2)If the request will reguire a clinical trial or activity that will take considerable time to respond properly too, that is negative . How negative will be determined by the impact of the delay which with clinical trials could be years. and 3)or the request could be a relatively minor one, such as is indicated in the NVX press release involving submittal of information that the company already has in their posession. So now should this specific request invoving NVX's CERTIVA be considered negative? I don't think so. What comes out at approval time will make it all go away. Being the optimist that I am i think there is some churning going on here between NVX and the FDA that will pay big dividends later on. We'll see. :-}

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