The Zerenex extension study is simply a compassionate use study which we chose to implement in response to demand from patients (and investigators in our study) who complete our long term study and would like to take Zerenex following completion of our long term study. This extension study was not requested by the FDA and there are no changes to our SPA agreement or expected timelines for NDA filing. It is a compassionate use extension program.
Keryx Biopharmaceuticals, Inc
"in response to demand from patients who complete our long term study and would like to take Zerenex following completion of our long term study."
how exactly do you complete the long term study and are still alive to ask for inclusion in compassionate use?
directors asked as well; sure looks like a done deal to me
might be a while for results, but every day that goes by makes positive results that much more likely
apologies in advance for any stupidness in the post;
couple of points
1. isn't this a violation of sec full disclosure? kerx should have released this data via a pr, not in a reply to an individual poster/investor from the yahoo message board; direct of ir shouldn't have disclosed this data; maybe this is kerx's way of letting longs know the results are good; no way of knowing
2. how in heck are the trial results not positive, given what she said?
if the results blow up, she's got problems
long kerx, just bringing up some issues
kerx should issue a pr on the extension; full disclosure