(Total Views: 291)
Posted On: 12/29/2017 12:44:56 PM
Post# of 72447
Expanded Access and Compassionate Use
We will only consider Expanded Access/Compassionate Use if the following criteria are met:
1. A sufficient safety profile of an investigational drug has been determined;
2. 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;
3. 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.
http://www.ipharminc.com/expanded-access-and-...onate-use/
Is IPIX considering the program for B-OM and K?
We will only consider Expanded Access/Compassionate Use if the following criteria are met:
1. A sufficient safety profile of an investigational drug has been determined;
2. 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;
3. 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.
http://www.ipharminc.com/expanded-access-and-...onate-use/
Is IPIX considering the program for B-OM and K?
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