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Biotech / Medical : SRDX - SurModics - Biotech IPO
SRDX 26.95-1.6%3:59 PM EDT

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To: Will Preska who started this subject10/29/2003 3:23:45 PM
From: Lance Bredvold   of 84
 
twobob puts warning into better perspective and speculates on reason for thrombus formation. Usually I try to post the article quoted, but in this case I am copying the whole post from Yahoo to get his opinion and the backup arguments by URL. It will also give me access to the TCT papers and foolish premise listed several of them as good reading earlier this morning--I put them on the side to read before adding them here and got caught up in other activities (a nap). (gg). One of my best resources from TCT I attempted to post here several times a while ago and never could get the URL to come up correctly. So at least this gets one to the site.
twobobuk 10/29/03 11:38 am
Msg: 6186 of 6252

Thrombosis due to Cypher is not new news and has been well aired on this board if not fully taken on board.

eg When the UK issued a warning letter

devices.mhra.gov.uk 256D94002EE7FE

(edit; while in editing period I attempted to use the above URL. It does get me to a UK site which is probably worthwhile, but perhaps the numbers must be added manually to reach that particular paper. After WhatsNew/FE7A033DA6651DC580 256D98002EE7FE showed on the Yahoo post but not all shows up here).

But the big Docs that do JNJ's trials dispute there is a problem
tctmd.com

Yet the regulators still question which is why we have the FDA releasing a letter today.

For myself I have a personal opinion, but no proof, about what the cause may be. The theory is that the rapamycin drug is thinning the fibrous cap of vulnerable plaque causing rupture and thrombus formation.

Also people say its only x% thrombus but they miss the big issue of safety versus efficay. The stockmarket is focused on restenosis rates. Is it 8% or 9%? One is better than the other. The regulator focuses on other data - the safety data.
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