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Biotech / Medical : ACMI - Accumed Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Sigmund who wrote (958)	1/6/1998 12:30:00 PM
From: Frank Buck	Read Replies (3) \| Respond to of 1894

Sigmund, Something doesn't sound right! You are saying that a U.S. based medical diagnostic Company (NeoPath) went for FDA approval (on a newly emerging fully-automated technology) with the hopes of receiving approval from having a key (ringer) board proponent and insufficient data? The safety aspect of the primary-screening technology is obviously of considerable importance. Especially in light of the 70-75% of the slides being ear-marked for further review manually. The scenario you describe would really make me question the competency of NeoPath's management and assessment of their own technology. Even accepting your premise that NeoPath's submittal team were noviate in their first submittal, anyone with an eye for governmental processes should realize that less is not more when dealing with public health safety. Granted that my recent talks with NeoPath-IR corroborate your depiction; Doesn't the whole thing sound like the initial application was done on the fly? The flip-side is that NeoPath IR said they were "armed to their teeth" (my term) this time with reams of new data. The two articles that Cisco re-linked in his early morning post, throws a "shadow" on the integrity of "some companies" compiled data. Staymates statement of:<<Statements become facts in two ways: first if they are proven correct, and second, if they are never challenged.>> seems to be at the heart of this second attempt. I believe the preliminary board-(first hurdle)on Jan. 28 may "pass" to the primary FDA, and then the numbers will be really poured-over. I don't see your logic in the assumption that if NeoPath doesn't receive preliminary-board approval in January, that AccuMed's Kirby-Bauer apparatus will suffer the same fate. Your tit-for-tat conclusion is easily rebuked by virtue of the FDA originally turning down NeoPath and granting AccuMed's TracCell approval in August. Frank