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Biotech / Medical : North American Vaccine (NVX)
NVX 1.035-5.5%Dec 30 3:59 PM EST
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To: kech who wrote (15)1/21/1997 1:10:00 PM
From: Don W Stone   of 35
 
Tom; This should interest you.
I made quite a few phone calls this morning re what was the lastest thinking on FDA approval.
First i will say there is just no such thing as a date when the FDA will announce anything so few even venture a guess that they want to put their signature on. It truly comes down to any day now with most really looking for something within a few weeks but that can slip as it seems to more often than not.
That just goes with the territory . You buy a stock that is up for FDA approval and plan to throw away not just your clock but your calendar.:-}

Second, Everyone feels it not a question of IF, but WHEN will the FDA approval come. I buy that thinking 100%.
What I am hearing is that the FDA has everything they need, to include the label request, to grant the approval. When I say this I am really making a statement about the clinical data. That is what that FDA Avisory Committee meeting 3 months back was about. " Is the clinical data adaquate to support the findings, etc.?" The answer in NVX case by the FDA is; YES. :-}
If it isn't acceptable/adequate the FDA informs the applicant and that often means going back to conducting more clinical trials and generating more data; that can be a very expensive and time consuming process. Such is not the case with NVX.

ALL THAT IS REQUIRED NOW BY NVX AND ITS INVESTORS IS PATIENCE, PATIENCE, PATIENCE. :-}
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