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You raise some good points. NFLD started enrollment for Phase III in Sept. of '97, and it's possible they could complete the trial this year...which, with a 12 month FDA review time, could lead to an OK to market in 1999. I don't know the status of the trial, however. My info on product launch was taken from their 10-K. As to "where are they going to get the money and expertise to build an FDA approved facility"...they've already shown the expertise in building their pilot facility, and written in their 10-K, "The company believes its existing manufacturing process can be used without substantial modifications to produce commercial quantities of PolyHeme in larger facilities." While NFLD has said they plan to manufacture PolyHeme themselves, they've also indicated that a partnership could be considered. With about $50mm in cash, and an historical burn rate of just over $7mm (although with the larger trial costs, it's almost certain to be greater) the company isn't in dire straits regarding money, and should be in a strong position if they were to seek a manufacturing partner, IMHO. As to Biopure...sure they have an approved facility to manufacture their vet product, but is it OK'd for Hemopure? Does it have sufficient capacity? And as I recall, Hemopure just recently entered Phase II trials...which puts it substantially behind NFLD on the trials trail. Please don't consider my dissent as disparagement, as I do appreciate your comments...looking through another's eyes broadens ones perspective. Best regards, Merritt |
