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Gold/Mining/Energy : Nuvo Research Inc
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To: VAUGHN who wrote (8475)1/22/2002 11:35:45 AM
From: Cal Gary  Read Replies (1) of 14101
 
Hi Vaughn

Wolf and Mark could probably answer your questions best on this thread. But they're out right now, probably shopping for party clothes in anticipation of FDA <G>.

I'll give it a shot.

1. What can possibly be taking so long to get HC & FDA approval? It seems we have been waiting for more than 9 months. Can someone explain the holdup to me? Anyone in the know?

Biotech and Pharma operate in a highly regulated environment.

IMHO, FDA is on schedule. I got April 1999 start date for final 'final' FDA submission. That's 34 months ago. Normal expected baking time is 36 months. Sept 11 may have set us back a few months.

April 1999 FDA submission ... imply completion of Phase III
May 1999 signed lockup shutup agreement with JnJ for US market
Sept 1999 Phase III presented
Nov 1999 Phase III presented at another venue
Dec 18/19 2001 FDA Plant inspection
Waiting for:
- FDA Plant Inspection Report due anytime between Feb 1 to Feb 15.
- depending upon a plant inspection approval, then expect FDA Approvable Letter within a month thereafter.
- Sign marketing agreement with JnJ McNeil Health Care upon successful FDA Plant Inspection report.

IMHO, HC is in overtime mode. Many here and at SH have expressed their reasons, mostly negative. HC sets the rules and they breaks them too. So major uncertainty. HC track record is to approve after FDA approves. Looking for a surprise.

Gotta run, may look a you second question later.
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