Is there any comparative data available for post-treatment deaths in either of the last two trials? This was a major issue for Telavancin during its FDA approval process.
Every other clinical parameter is in place and makes Tedizolid as close to a sure thing as you can get for antibiotic approval, but I can't find any data on this last measure.
...the last time you were rehashing DD irrelevance, as Kitty said SP was $6.50. You never got back to the MB with info whether you thought Ted was a buy or not based on that. Now, again you bring up some obscure point casting doubt. Me thinks late-night-lab-rat is a good contrarian indicator.
Since you're likely to dense to understand posts that aren't directly addressed to you, I'll respond you as well.
"You never got back to the MB" - Never said I was going to, and was only asked by Kitty who didn't seem to understand the inquiry. Didn't see much necessity at this point since she wasn't concerned about it.
"... with info whether you thought Ted was a buy or not based on that" - Literally said in this exact thread that Trius is basically a sure thing, with the caveat that I was looking for a personal piece of information for myself. What would you like me to do? Come to your house and hold your hand while I reassure you that TSRX is a strong buy?
"Now, again you bring up some obscure point casting doubt." - Yes, nothing casts doubt like someone saying "tedizolid is as close to a sure thing as you can get for antibiotic approval".
"Late-night-lab-rat" - Really, are you in middle school? You both need to grow up. As I already said, if you're this insulted that I called out your completely inaccurate post in the other thread, then just respond there instead of throwing around fictitious accusations.
Yes, or some kind of stalker. Every one has some agenda. When they say they are going to do something, then do it. #$%$, why bother posting if there is no follow-up. I could have written to IR, instead leaving it to some body being so worried about how to write a question, like it is some peer-reviewed article.
That would be listed in adverse events section and under treatment related adverse events. I don't see death listed. There are many presentations and posters available of the TSRX website.
You are both misunderstanding. I have gone through all of the presentations, as well as the JAMA and Prokocimer and Grau publications from Feb-April. TEAE and SAE are classified as complications that are first-degree causative, it's not long-term survival measure.
Here's an example to make this clear. If you've followed the development of ABT-199, you know that the trials were temporarily halted due to patient deaths from tumor lysis syndrome. This is a first-degree causative event, because the cells were so sensitive to BCL-2 inhibition that the immediate apoptosis flooded the patient's system with Na/Ca/K/etc. This would be a TEAE. This is not the same thing as overall-survival, which simply quantifies the number of patients who survived the condition they were being treated for over a long-period of time. Please don't confuse this with response rate or lesion measurements either, they're not the same thing.
This is why it's called "all-cause mortality". Theravance had to put this data together after the trials were completed because they didn't account for it and the FDA requested it. It's an important measure and something most physicians will want to know. Personally, I wouldn't prescribe an antibiotic based on acute lesion response if there was a statistical significance in long term post-treatment deaths in the studies. I'm not saying this is the case with Tedizoloid, I just can't find any data concerning it.
Kitty is not wrong, but take it further. Look specifically at listings for "serious adverse events (SAES)" in the metioned presentations if they give them. Because death is the ultimate (not only one) major definition for a SAE. There are also very different Sponsor (TSRX) reporting requirements, timelines for reporting them to the FDA in the TSRX dossier under its IND number for the serious events and your average run of the mill adverse event. TSRX data collection/reporting requirements ramp up heavily for SAEs.
If ya want to invest in bios regulatory stage, all should read the applicable Code of Federal Regulations relating to all these process of drug development. Examples would be 21CFR 56, 58, 312, and 314. they would help you to understand what actually goes on and who is responsible for what. They can be supplemented with guidence documents within the FDA website and processes like adverse event reporting, and the submission process. As Kitty says presentations within the TSRX website will help further!
The term "treatment related" imentioned s a critical term for evaluating causality for SAES or even normal AEs. Because you can have a death while a patient is in the study, but causality can be determined (principal invstigator for the patient) not to be related to treatment to your drug in spite of its occurance. Or it can be related? Its best for death in studies not to be present, but even if they are, is ot always fatal to your investment!
The point is, its simplistic to just look at the number of deaths (if any), but ya also must look at causality!