The Phase 3 HCT trial will enroll a total of 500 CMV seropositive HCT recipients at approximately 85 clinical sites in the U.S., Europe, Australia and Asia. We work with Astellas to design this adapted Phase 3 trial that includes overall mortality as a standalone primary efficacy endpoint or as part of a composite endpoint. The primary endpoint will be determined based on one year of follow-up from the first 100 subjects in the study and then data from the remaining 400 subjects will determine efficacy. This endpoint has the potential to support full approval in key markets with no post approval trial requirements. The endpoint selection and trial design were based on a thorough analysis of the Phase 2 data and extensive consultations with key opinion leader and regulatory agencies in the U.S., Europe and Japan.
Sentiment: Strong Buy
Fit biotech is working on a new HIV DNA Vaccine that when coupled with current retroviral drug treatments could eliminate HIV completely.
hofn. The key to the best vaccine may be the one that can work in combination with other medications to produce favorable results.
It's my understanding that this new catheter can respond to a lower magnetic field.Is that right ?
Do you read their last patent. It's already outdated.
Sentiment: Strong Sell