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Biotech / Medical : Lidak Pharm. [LDAKA]
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To: MCorbley who wrote (602)9/12/1997 2:31:00 PM
From: James Silverman   of 1115
 
Mike, etc.,
Here are some figures for you all:
Via SEPR quarterly report that I received today: "The levalbuterol NDA contains 168 volumes and is approximately 45,000 pages long, which is about one half the size of a typical NDA document."

You can simplify the filing and review process all you want, but it isn't as easy as file it and magically approve it in a couple of months unless the drug in question is of some sort of critical breakthrough. I would estimate, that once filed, it will take the FDA 2-3 months just to acknowledge that Lidakol is filed and the application appears to be in good order.

Michael-your whole premise is very simplified. I would be concerned about the many references to subset analysis and statistical significance or lack there of that was mentioned in the preliminary PH III press release. When trials need to be broken down to subsets, it is usually not a strong signal that efficacy is as clear cut as desired.
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