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Biotech / Medical : Neopath (NPTH)
NPTH 0.0006000.0%Mar 7 3:00 PM EST
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To: Gerry Pince who wrote (60)10/26/1997 12:43:00 AM
From: Sigmund  Read Replies (1) of 178
 
Nothing in his background suggests to me that he would be a good manager. What am I missing? What did you see there re low level managerial experience let alone senior management competence?

Nor does his experience profile suggest that he understands the FDA. NeoPath has been talking about a 45 day approval period for the acceptance of their primary screening PMA but then were told that no such approval period applies because this is an admendment to a previously submitted PMA not a new PMA. Is it too much to have expected the company to know this? If Nelson didn't know this, as their leader he should have made sure there was someone on the staff or an outside consultant that really understood the FDA process. They got blindsided the first time around and now I know why. The company just doesn't understand the regulatory process in the industry in which they compete. That is a terrible indictment on Nelson's leadership.

The upside is this PMA amendment will probably be approved much faster than they anticipate, perhaps in the coming weeks. But it makes me nervous that the company is novice to say the least in dealing with the FDA. I would be much more comfortable if professional management were brought in.
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