is that your head in the sand ? If you have such an inside track at srdx, please tell us why the top-coat is failing (process that can't be validated, causes stiffness in the stent, permits variable rapamycin release over time (i.e., brief shelf-life)...
you should lose that loser in a hurry.
yes, they did the coating for the IDE studies, it's just that the process wasn't adequately validated... can't say there weren't any issues with the IDE production batches because those units are not subject to the QSR/GMP regs... and once validation data were subjected to full audit (post-approval) it was learned that it was glossed over in the PMA...
agree that changing coating now is a big problem, but it's not like starting over if they can keep Cypher alive long enough to cover market share (~ 30%)... which appears to be Cordis' strategy by putting off FDA... unfortunately it's also putting off Precise carotid approval as well... (notice Guidant got it carotid stent approved even though panel reviewed their application later)... hint hint to Cordis...
The only inside info I have is on my underwear drawer, medicine cabinet, and refrige.
I didn't assume anything, I said it is possible......reread my post. I'm beginning to believe SRDX holders can not read! forget critical thinking.
Why do you ASSUME that SRDX is doing coating work for Cordis (other than development for next gen Cypher)??? Is that why they closed the coating plant in Bloomington? The LOGICAL assumption is you also have no inside info.
My critical thinking skills tell me it is possible that SRDX is manufacturing coated stents for Cordis in an attempt to help Cordis get the manufacturing/validation under control. (IF they are OK coming from SRDX, the problem is with Cordis manufacturing, not the product.)
Why do you (and 8 others) ASSUME Endo believes SRDX does ALL the manufacturing of the coated stent? And then from that assumption you decide Endo is a liar.....?
Why, because you don't like what he is saying???Bad way to protect your invesment dollars.
BSX is no match for the company with the best ability to spin data, JNJ. JNJ has proven they are the master of spin! I believe that this years TCT will be very revealing. So many wonder where the onger term Taxus data is, and the simple fact is the approval and the data is about 18 months behind JNJ's. TCT should provide some answers with angio and Ivus f/u of several of the studies. The next big one will be the Reality trial, and I believe some data from that trial may be available by the AHA (not sure). Lots of rumors that if JNJ had the choice today to do the Reality trial they would not do it. I have no link to back this up, for the facts will be open for all to see very soon!
There was a question of when the improved delivery system for JNJ will be available, does any one know? The poster said 3 months, however I believe the FDA is making them present data, and I do not know of any study they have done with a change in system, does anyone? Just questions, no facts, but the answers are coming very soon.
Yeah, and maybe all of BSX's manufacturing facilities will simultaneously collapse and the company will go bankrupt and your stinking shorts might be worth a penny or two... yadyadyada...
Get lost, loser!
is the upcoming comparative studies and long-term data. As independent investigators (like Serruys and the Swiss) try to replicate filtered/BSX BS adjudicated and distorted Taxus 4 data, hidden Taxus 5 data and Taxus 6 data that shows 9 month MACE of Taxus = bare Express, the docs will finally wake up and realize that by 18-24 months Taxus does not prevent restenosis! Reality trial will prove this with p values in the 0.01 to 0.001 range that Cypher has far superior long term results. That is when we will see a huge switch back to Cypher which is the only DES with serial late angio follow up out to 3 and 4 years. Where are those data for Taxus? Not there! Why not? BSX does not want these Toxol stents resteudied. Problem is newer studies BSX distorters cannot throw out the bad data points that they don't like. Truth about Toxol is coming and no patient will want one! Sticking, polymer webbing and deflation issues are not solved! Recall still very possible.