The trial includes angiographic and Intravascular Ultrasound follow-up at eight months for a subset of patients. Upon completion of this trial, Medtronic will have important comparative data against the Taxus stent in addition to data gathered on the Cypher stent from Johnson & Johnson in the Endeavor III trial.
<<Is there a precedent you are aware of for approving devices based on secondary endpoints, when they fail to meet the primary endpoint?>>
I don't know but since TVF is the primary endpoint of Endeavor 2 your question may not apply to their submission.
<"YES, you idiot... how many ways do people have to tell you... It all comes down to making the best case to support marketing claims (that's labeling) to the FDA. Primary, secondary - who gives a s#*^?">
The FDA does:
"Both Genta�s Genasense and Allos�s RSR-13 missed their primary endpoints. Genta
tried to get approval on a secondary endpoint, and Allos wanted approval based on a subset analysis that was not prespecified. The ODAC panel rejected both arguments, sending three strong messages to industry: (1) Don�t expect approval of a drug that misses its primary endpoint, (2) slicing and dicing data won�t turn a sow�s ear into a silk purse or a failed drug into an approvable one, and (3) ODAC can make tough decisions even in the face of Congressional and patient pressure."
This, of course, speaks to drugs, not devices.
The secondary endpoints in oncology trials (e.g. time to disease progression) are generally of lesser importance than the primary endpoint (e.g. mortality). The medtronic example zeitgast used has secondary endpoints which are of MORE clinical importance than the primary endpoint (late loss) so you could make a much stronger case for approval. I assume what he says is true.
However, I would still like to hear from a credible source (i.e. zeitgast, or pretty much anyone other than a REGTEK ID) as to whether such approvals have precedent.
YES, you idiot... how many ways do people have to tell you... It all comes down to making the best case to support marketing claims (that's labeling) to the FDA. Primary, secondary - who gives a s#*^?
And you still have your original moronic question.... Obviously you don't know what the Gray Sheet is... it's for devices... You profess to know something about NDA's... well have you ever heard of the Pink Sheet ? Geesh...
I'm afraid it is you who has once again out-witted yourself...
I don't come to this board seeking approval, from you, myself or anyone else. Sorry... but I'm just don't care what others think. Too old for that.
It's painful to witness your desperate need to be liked, or thought of as learned on this board (in spite of a glaring JNJ bias). It's quite transperent you know...
Thanks for your response, but it still leaves me with my original question.
Is there a precedent you are aware of for approving devices based on secondary endpoints, when they fail to meet the primary endpoint?
<"if you agree, then way do you ask such a dumb (foolish) question?">
Obviously you didn't understand my post.
My response was:
By which I am agreeing, and emphasizing, that your posting under four different user id's over the last month ("labels"), to give the appearance of support for your own posts, is indeed "what it is all about".
My apologies the irony was beyond you.
SOOOOO....I GUESS THIS WAS THE BAD NEWS FOR BSX THAT YOU WERE YELLING ABOUT?
12:32 JNJ Johnson & Johnson stent trial data presentation delayed - Dow Jones (58.63 +0.48)
Dow Jones reports that the principle investigator of JNJ's Reality stent trial says data probably won't be available until next year. Researchers had hoped to present data from the trial, which compares JNJ's Cypher drug-eluting stent to BSX's Taxus drug-eluting stent in real-world use, at the American Heart Association meeting in Nov, but now the target appears to be the American College of Cardiology meeting next March.