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Biotech / Medical : IVAX Insider Trading
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To: John McCarthy who wrote (70)9/27/1997 8:53:00 PM
From: flickerful   of 756
 
>>>accordingly, we are not attempting
to obtain approval of Paxene(TM) as a generic version of
paclitaxel, but rather have undertaken extensive clinical studies
and have submitted a full New Drug Application for Paxene(TM). Our
studies independently demonstrate the activity of Paxene(TM) for
Kaposi's sarcoma, and support the benefits of dosing schedules
which differ from those approved for TAXOL(R) -- in short, I am
very excited about the clinical results we have obtained. I am
hopeful that, like other non- controversial cancer and AIDS-related
medications, Paxene(TM) will similarly receive an expeditious
review at FDA."


were ivax to apply for generic approval, that date would
have applied. but, from your post, it appears they are
trying to stay on a fast track...applying for a full new
drug designation, relying on an intent to administer paxene
quite differently than taxol.

randy
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