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

To: Sigmund who wrote (706)	12/18/1997 12:43:00 AM
From: Cisco	Read Replies (1) \| Respond to of 1894

Sigmund, I think there is some confusion on which systems can read ThinPrep. It has been reported on the Motley Fool that Papnet is not designed to read ThinPrep: fool.yahoo.com In a press release last year it was reported that AutoPap could read ThinPrep: businesswire.com Whether something has occured since then that has changed that assumption, I don't know. Kinda funny they haven't mention it since? Also, I am not sure whether an additional FDA approval would be needed for AutoPap to read ThinPrep or not. I would assume it would especially as a Primary Screener. In a recent press release from AccuMed, it has been reported that TracCell can read ThinPrep: accumed.com I believe the reason that all the analyst have gone to a hold recommendation on NPTH is because NPTH is a one product company whose entire stock price depends upon the outcome of Jan. 28, 1998. My gut feeling is that it probably will get panel approval, but there are several on this thread that would strongly disagree with me on that. Many believe that FDA will drag its feet and be slow to approve a Primary Screener. I assume that even if it gets panel approval, it still has to wait for full approval from the FDA. Do you know? You may also be interested in the Proposed Guidlines for Primary Screening Instruments for Gynecologic Cytology: cytopathology.org I would encourage you to take a close look at AccuMed. I believe we will see ACMI selling for at least $5.50 sometime next year. That would be a 283% return. NPTH would have to sell for $41.21 to give you that same percentage return. I believe we will see ACMI at $5.50 long before we will see NPTH at $41.21. I didn't know whether you have seen the above links or not, this may be old news to you. Good luck. Cisco

To: Sigmund who wrote (706)	12/18/1997 1:18:00 AM
From: Frank Buck	Read Replies (2) \| Respond to of 1894

Sigmund, First of all I should state the the information I have regarding the inability of the NeoPath System to read the ThinPrep Mono-layer slide comes from the Motley Fool Article of 11/03/97. Here is the quote; "If the Cytyc thin-prep becomes the standard test for cervical cancer screening, Neuromedical Systems and Neopath may be in trouble. Autocyte's machine can screen the thin-prep specimens; Neuromedical's cannot." fool.com (By the way did you know that AccuMed's system is capable of working with the CYTC ThinPrep Monolayer slides?) Secondly while I agree that they are two mutually exclusive entities, it is my belief that the FDA approval of the CYTC Thin Prep System has turned up the heat for all perspective FDA approval seekers in this sector. The NeoPath system for automated detection of aberrant H.P cells was originally deemed unsafe by the FDA. This second attempt may be suspect due to the considerable amount of data given to the FDA with the consideration for approval of the ThinPrep System. In other words a higher degree of sophistication is implied by the FDA reviewal of the ThinPrep System. The NeoPath machines inability to read the newest slides shouldn't in and by itself preclude the FDA from granting or denying approval to NeoPath. However the above sited "new awareness" coupled with the numerous allegations being thrown about in this sectors court battles may raise eyebrows in an FDA Approval Panel. The fact that the lawsuits are still hanging may compound the safety issue enough to preclude the FDA from giving approval under the auspice that additional data is needed to confirm the safety allegation. The FDA Approval Panel realizes that whatever they do at this point will be closely scrutinized in court. Disected step by step if need be. I am assuming if they are going to make a move, it will be to "error" on the side of waiting for more studies. The safety aspects of an automatic computer assisted microscope system for the detection or absence of a few aberrant cell seems sufficient to warrant the highest level of all available data. Not just data submitted by the company that has a vested interest in the marketing of the product. The trials will bring to light all data from all the players. What has the FDA got to loose by gaining approval right now? What do they have to loose if they don't grant approval? Sorry but I don't think NeoPath is gonna make it in January. Judging from the shorts I am not alone in my perception. Hope this answers your question. Frank