Cell Therapy News/Articles, page-12474

Agreed. I also think that the FDA ignores and delays the CHF trial results at its peril.

The AHA conference was huge, of course.

The NEJM article (if it happens) will be even bigger. That article will send the word about Rex-L and mortality reduction around the world.

At that point, pretty much every heart doctor in the world is going to know that there is a BETTER, SAFER way to treat and yes, to SAVE their patients. One shot, no side effects, 50-80% reduction in mortality. Bam.

FDA sends that back for another five-year trial...after asking MSB to identify the patients that best responded to the treatment? Of course it's possible...but that outcome just seems more unlikely the more I think about it.

Give a conditional approval and ask MSB to come back with results to prove effectiveness in 4-5 years. But to just deny it to patients and doom half of those treated to death by placebo? Not sure that works, even for the heartless FDA.