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Biotech / Medical : Lidak Pharm. [LDAKA]
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To: luis a. garcia who wrote (612)9/12/1997 2:43:00 PM
From: James Silverman   of 1115
 
Luis,
All new chemical entities need to go through carcinogenic testing. This type of testing would have been a part of the initial NDA of a few years back and naturally would not have to be done again.

Any drug company works with the FDA on their filing and for guidance as to how to run their trials, this is commonplace and simple logic. The bottom line with the FDA is still the same, you need to show statistical significance to get approval. Have you not noticed how many drugs have been slammed at the FDA in the past few months?
They didn't show this the first time around and it is still not clear-cut that this has changed. The problem with herpes is that there is a huge placebo effect for a condition that is largely psychological-ie stress can cause outbreaks.

Are you merely a subscriber to Bud's letter or are you
a worshipper? :-)
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