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To: Joe Krupa who wrote (10553)8/14/2002 9:27:08 AM
From: Montana Wildhack  Read Replies (2) | Respond to of 14101
 
I was talking to my mom yesterday. She doesn't like
the markets and was pushing for me to put my money into
more practical things to cover my bases.

So I went out yesterday and got a bottle of LaFitte
Rothschild and a body bag.



To: Joe Krupa who wrote (10553)8/14/2002 11:36:49 AM
From: twentyfirstcenturyfox  Respond to of 14101
 
Joe, I have to say, those are very valid assumptions. So now - what do I tell mywifeisgonnakillme? I have just finished explaining to her that we have this special financing here, and that, as a result, the stock price has been weaker than it would otherwise be. Acqua is one in five, you say? How about: there's these 15 Amigos, see....
just kidding. Wolf, you're a sick puppy. Best of the day. Ta. Fox.



To: Joe Krupa who wrote (10553)8/15/2002 3:30:21 PM
From: Joe Krupa  Read Replies (1) | Respond to of 14101
 
FDA Drug Review Steps

Here they are again from another FDA document:

Drug Review Steps
1. Pre-clinical (animal) testing.
2. An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
3. Phase 1 studies (typically involve 20 to 80 people).
4. Phase 2 studies (typically involve a few dozen to about 300 people).
5. Phase 3 studies (typically involve several hundred to about 3,000 people).
6. The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
7. Submission of a new drug application is the formal step asking the FDA to consider a drug for marketing approval.
8. After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
9. If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
10. The FDA reviews information that goes on a drug's professional labeling, guidance on how to use the drug.
11. The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
12. FDA reviewers will approve the drug or find it either "approvable" or "not approvable."


fda.gov