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Biotech / Medical : North American Vaccine
NVX 0.988-5.4%3:59 PM EST
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To: Paul Lee who wrote (198)1/9/1998 8:56:00 PM
From: Don W Stone  Read Replies (1) of 507
 
Paul Lee: Very well said. It is a giant step closer.
Here is my interpretation:

That the FDA is saying that NVX/CERTIVA is on track for completing final steps for licensure and that the
FDA's objective is to promptly complete the process is certainly VERY POSITIVE.
It says at what stage in the approval process NVX is at. " final stages for licenture".

The FDA has requested additional information. The Company says they will provide it shortly.
That says to me that whatever it is it is readily available. We are not talking here about another trial. We are
talking about compiling some information that NVX has in a usable form for the FDA reviewers.
The Company makes a statement that they anticipate that the reveiw process could be completed during the
first quarter of '98 , or shortly thereafter. I interpret this as saying sometime no earlier than perhaps mid
Feb but before May 1st.
To the long term investor this news can only be interpreted as positive. CERTIVA is on track for approval.
What has to happen to get approval is defined. It is indeed a giant step forward.
:-}. Hang in there, its really happening. NVX will get the full FDA approval that they deserve.
It is only our expectations, however they are derived, that make us want things to be different now.
It is only our expectations that make good news a short term disappointment.

:-}, :-}, :-}
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