Re: Trial Enrollment Difficulties
in response to
by
posted on
Jul 04, 2012 02:38AM
Edit this title from the Fast Facts Section
We don't know the parameters that MNKD had put forth for their study but if any of you have ever donated blood or plasma will know that even doing that can exclude many people due to health reasons. A high or too low heart rate, out of range blood pressure or out of "normal" range hematocrit reading can make one ineligible to donate.
Having some experience myself with the FDA makes me know that a company has to make damn sure they are darn near perfect with what they do to no foul things up with the agency. Thus, finding the "right" candidates is no easy task and why trials are so darn expensive.
But, if MNKD has been able to target and enroll the right candidates and they produce data from the trial that demonstrates how effective and safe Afrezza is, watch out! Someone is going to become a millionaire! :)