Biotech Values

[jq1234]

It would be close call based on the data we have now. Even if approval, it would be with very strict condition IMO. The problem is dose issue, what would be effective and safe dose? No one really knows at this point, it's all guess work. FDA doesn't put guess work on drug label, it is based on data. If trials had used dose titration method similar to Jakafi for MF, it would be easier to get approval because there would be more data for various doses.