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

To: Tokyo VD who wrote (605)	4/8/1998 9:25:00 AM
From: Mark J Trudeau	Read Replies (2) \| Respond to of 1202

Press Release at 9:00am: newsalert.com Yea!!!!!!!

To: Tokyo VD who wrote (605)	4/12/1998 6:08:00 AM
From: Steve H.	Read Replies (1) \| Respond to of 1202

So What's your source, Tokyo? Is it the FDA review, 'cause I'd like to know where I can go and take a look at it. Got a URL? Let me share something I found (and I'll quote my source so that you can judge the validity of the information --see the value?) From the most recent 10-K file by PLC (use EDGAR www.sec.gov): " Since the Company's last annual report on Form 10-K, the following significant events and accomplishments have taken place: Review of PMA by FDA Circulatory System Devices Advisory Panel. In July 1997, the circulatory systems devices panel of the FDA convened to review the Company's PMA application for TMR using the Heart Laser System. In a nine to two vote, the panel recommended that the PMA application not be recommended for approval pending further patient data. In September 1997, the Company received a letter from the FDA, which agreed with the panel's recommendation of non-approval and completion of the follow-up data. Included in this letter were 12 requests for further information relating to follow-up data, which when answered, would place the PMA application in "approvable form." PLC Systems Completes Data Submission to the FDA for The Heart Laser System. In December 1997, the Company submitted all of the requested data on TMR using The Heart Laser System to the FDA. The submission was in response to the list of 12 requests received from the FDA following the July 1997 panel meeting. The 12 month data from the controlled randomized study of TMR versus medical management suggests that patients with end-stage or chronic coronary artery disease who undergo TMR using the CO(2) Heart Laser System fare significantly better than patients on medical management. In addition to the 12 month data on the controlled randomized study, the Company also submitted favorable long-term, three year angina data on more than 60 TMR patients from its earlier studies. " So, PLC is saying that the FDA made 12 requests for follow up patient data. Furthermore, the FDA indicated that if this information were to be made available then the product would probably be approved. PLC complied. Sorry, Tokyo, I'm missing something. It's pretty significant if you are saying that the FDA wants and explanation of the mechanism of action and then PLC doesn't disclose it in their 10K. In fact, the company is quite consistent in mentioning in all of it's press releases that it still doesn't know what the mechanism of action is. Do you see the breakdown in logic here? 1) FDA makes 12 requests for information 2) FDA states that the data is follow up and patient related 3) PLC satisfies the requests. 4) PLC continues to assert that it doesn't know the mechanism of action. If "mechanism" is as important as you claim, then surely it's explanation would be at least one of the 12 items requested by the FDA. So: How can PLC satisfy all of the FDA requests and still assert that it doesn't know the mechanism of action if explaining the mechanism of action is one of the FDA requests? For your statement to be true, Tokyo, then PLC must be lying in it's 10K. Is that what you are asserting? So, back to my original question, Tokyo. What's your source? FTR, I am long PLC (obviously)