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Biotech / Medical : PLC Systems -- Ignore unavailable to you. Want to Upgrade?

To: Tokyo VD who wrote (603)	4/8/1998 1:51:00 AM
From: Steve H.	Read Replies (1) \| Respond to of 1202

What's your source, Tokyo? Although I don't have a source to back up my conclusion, I believe JF Dowd is correct. It is not incumbent upon the company to demonstrate the device's action, only prove that the benefits outweigh the risks. I point out that a lot of pharmaceutical compounds are on the market with only theories about their action - no direct evidence. The fact is that they work and they carry acceptable side effects. The FDA has approved them. Why would it be any different for PLC's device? As for the reason for non-approval the first time through, my broker (who is a market maker) told me that the reason was because the detail of the double blind clinical trials was not complete. PLC later announced that they did indeed have the data but did not include it in the application. Why? I don't know. This is their first product and the first time they are working with the FDA - it may just be lack of experience. That's what I'm counting on. FTR, I am long on PLC.