RE:RE:From a Aug 28 WP article quoting Gottlieb of FDA fameI think there weren't more comments for two reasons..one being that all longs know the intricacies of PLIs processes and don't bother responding.. and the many more on this BB that may indeed not.
Simply put..human plasma is not a" drug" as such.The FDA looks at PLI differently...it has to.A traditional drug is usually chemical based ..either wholly or percentage wise...its because of the inherent possible complications from that very fact that can lead to complications in humans...(ever see the list of possible side effects from some drugs?).
Plasma ..being human derived..falls under a different category..it cannot possibly be as toxic to humans..its only the efficiency that matters.And of course that would very from person to person..but never - the -less..if the end result is favourable with no side effects..how can that ever be viewed as anything but positive?