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Biotech / Medical : ACMI - Accumed Inc.
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To: Cisco who wrote (708)12/18/1997 1:16:00 AM
From: Sigmund  Read Replies (1) of 1894
 
I believe that the advisory panel will make its recommendation and the FDA can then accept or reject this recommendation. This means that a final decision will not come on Jan 28 but the recommendation of the advisory panel will most likely be accepted. That is what happened the last time around.

I believe that there was a test of the AutoPap system with ThinPrep and that it was very encouraging, but I also think that NeoPath needs to do more work to make this an operational (rather than a test) arrangement. I would assume that additional approvals would be required probably requiring a similar test as was submitted with this request for approval as a primary screening device.

But all of the above is just my understanding of the situation and I am not an expert on this. So please seek independent confirmation if it is important to you.

I agree that the upside potential for Accumed is significant. I don't fully understand why the stock has been beaten down so much but the entire sector outside of Cytec has been under pressure. I would think that approval for NeoPath might turn out to be positive for Accumed. Certainly if the FDA is not willing to take some risks and approve a change in the way labs operate, that would be very negative for all companies in this sector.

If the FDA opts for careful introduction of new technology, the medical marketplace can then determine which approaches have the most merit. As pointed out on this thread, it may well be that certain combinations of approaches using technology from multiple companies makes the most sense from a medical and economic point of view. This can not happen if capital is not available for development, and capital will not be available if companies are unable to get their products approved for use.

In this regard and also with respect to improving the reimbursement situation, I would think that more of a precompetitive spirit of cooperation is more in the interests of the investors, medical profession and general public than intense internecine warfare.
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