RE:RE:RE:RE:Something to noteThe last study for ibalizumab was a phase III, even though it had only 40 patients in it.
https://www.nejm.org/doi/full/10.1056/nejmoa1711460
SPCEO1 wrote: Trogarzo was a drug the FDA loved and so it had a lot of shortcuts ont he way to approval. I believe the FDA actually contributed $500,000 to Taimed to help develop the drug. Small studies, no phase III required were other benefits along with the lack of a comparison arm to their trials. This study looks to fix that last one if I am reading it right.
PWIB123 wrote: Sounds promising, but am I reading this that they effectively took another short-cut?