Megazyme International is developing a new investigational drug called Alzipill to treat Alzheimer's disease. Alzipill is currently in Phase II clinical trials. Megazyme is considering making Alzipill available for treatment use before it receives FDA approval. This would involve submitting an expanded access IND and preparing a new protocol for IRB review. However, there are risks like serious adverse reactions that could impact the ongoing clinical trial. Megazyme will need to address requirements like informed consent and training clinical staff on the expanded access use of the drug. The company's future is dependent on positive results from the current Phase II trials.