You don't think the toxicology is proved up???
Phase II[edit]
Once a dose or range of doses is determined, the next goal is to evaluate whether the drug has any biological activity or effect.
[1] Phase II trials are performed on larger groups (100–300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Genetic testing is common, particularly when there is evidence of variation in metabolic rate.
[1] When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.
Phase II studies are sometimes divided into Phase IIA and Phase IIB. There is no formal definition for these 2 sub-categories, but generally:
- Phase IIA studies are usually pilot studies designed to demonstrate clinical efficacy or biological activity ('proof of concept' studies);
- Phase IIB studies look to find the optimum dose at which the drug shows biological activity with minimal side-effects (‘definite dose-finding’ studies).
Some trials combine Phase I and Phase II, and test both efficacy and toxicity.
https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_II
Further analysis for 100mg is pending and 200mg is well tolerated considering the Atripla is pretty harsh cART.
Time will tell, IMHO I don't think they will do 2b, nine trials of safety data is a pretty good base of knowledge for BIT225. The greater questions are how well it works for different combination of cART in the market.
