Thanks for the link. That page doesn't seem to hav
Post# of 72440
I found this info to be interesting (my comments in red)
Quote:
We will only consider Expanded Access/Compassionate Use if the following criteria are met:
A sufficient safety profile of an investigational drug has been determined; (all of IPIX's drugs have been shown to be very safe so far)
if the Expanded Access / Compassionate Use will not interfere with or compromise clinical trials that could be used to support an FDA application for approval of the treatment; (hmmm, that's a good question)
and when there is an adequate supply of drug treatment for the necessary clinical trials before supplying drug treatment for Expanded Access / Compassionate Use patients. (having adequate supplies could be a problem, with the new formulations in oral form being developed)