To: Oblivious who wrote (816 ) 4/30/1998 1:16:00 PM From: Oblivious Respond to of 1202
Interesting post from Yahoo. Dave infocom14 Apr 30 1998 11:55AM EDT Relevant points from yesterdays call 1. FDA approval mid to late summer with medicare reimbursment after. 2. Japan is progressing well. Have 60 patients and are collecting data. Will be a minumum of 6 months before they have collected data for the approval, although they hope to use the FDA data once it is approved. Rest of world looks towards US and FDA for confirmation. 3. Because they are in the FDA approval phase now they cannot hype the product or try to sell it (although they can take unsolicited calls...which they have.) This explains some of the cautiousness, they don't want to mess anything up, although they can be excited and educate people. 4. THE STATISTICS: They are working hard to finish. Don't see any problems. Importantly, their endpoints are Angina and Profusion, while the competitors are using Angina and Exercise tolerance (the company believes). Their feedback from FDA has been Exercise Tolerance is too subjective. Not a good endpoint even if they get approved, clinicians will like the angina profusion results, less subjective 5. Their laser drills the hole in one shot and is synchronized with the heart beat, less arrhythmia 6. Meeting in Boston for Thoracic surgeouns: A doctor form India, who has done 300 TMR PLC operations, will present on the benefits of using TMR in conjunction with bypass. Management is redoubling their efforts on their study in hopes of ultimately expanding what TMR can be used for. 6. Smith Barney, No mention of the upgrade, but 3 of them asked questions. The convertible debts strike price is 19+ 7. LEAD ON COMPETITION: NONE OF COMP HAS FILED. Takes at least 6 months to get a hearing. Once PLC gets approval everyone else loses fast track, although if they are in the stack they won't get pushed down. Therefore, a minimum 6 month lead. 8. Peer Journals. Looked upon by FDA and clinicians favorably, PLC has had 15+; competition 1. ...Just some Facts to help out. I am long, and nervous based on recent events (and all the crap on this board). First call estimate was -.23 and management expects similiar numbers for 2 more quarters. Good Luck.