Innovation Pharmaceuticals Inc (IPIX)

[biodoc]

Unfortunately, compassionate use is not risk-free for a drug developer. One company I follow had a 'hold' placed on their Phase 3 trial by the FDA after a very sick cancer patient died while using their drug under the compassionate use program. It was an inappropriate setting for use of the drug but it really messed up the perception of the drug, the perception of the trial, and the statistical analysis after the clinical hold was release and the trial was completed. It seems an unlikely problem in the case of IPIX's drugs but it's not necessarily win-win for the company.

biodoc