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Biotech / Medical : Northfield Lab(NFLD) -- Ignore unavailable to you. Want to Upgrade?


To: Merritt who wrote (64)7/7/1998 12:28:00 PM
From: Vector1  Read Replies (1) | Respond to of 148
 
NFLD has no chance of a product launch in 99. They have not finished their phase III and it is unlikely they will be done in 98. The earliest they could file a PLA would be mid 99 with approval in 2000. Moreover they only have a pilot facility. How are they going to produce the product. Where are they going to get the money and expertise to build an FDA approved facility. I think you are looking at a 2001 product launch.

Biopure is a private company. It is much more difficult to tell when they will be in a position to get approval and launch. However, from the vet approval we know that they have a FDA approved manufacturing facility that is producing the vet product in commercial quantities.

In sum, I think NFLD has a quality product. With Baxter back to the drawing board the issue is not competition but having the resources to get approval and move into commercial production. The market is clearly large enough for multiple competitors. However, without a partner I don't think NFLD will make it.
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