Biotech Values

[ghmm]

I take the start of submission and not the "starts its review" but even by that standard the authors aren't quite accurate according to this chart

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM218757.htm

Never-the-less the authors were implying the FDA process is quite good when they in-fact extended their review by 2 months which is moving in the opposite direction. Sure the stats can look better if you get more time to review to be considered within your guidelines.

I don't claim to be familiar with 21st Century Cures Act and I don't doubt it likely has points that I wouldn't support. As far as the review process is concerned I just get the impression the authors see only the risky aspects without weighing in on the potential positives aspect to get medicine to patients who may have no other options.