pharmaphorum recently published an article written by our Founder and CEO Yin Ho and Research Analyst Daniel Sanchez: "When Measuring European Regulatory Approval, the Timestamp Matters." The article looks at cycle times in regulatory decisions and how they are being measured in the US and Europe. A cycle time measures the time from the date of submission, through date of approval. We noticed that some of the analyses involving the European Medicines Agency (EMA)’s cycle time used an inappropriate endpoint, resulting in cycle times that looked two months shorter than they actually are.
Adding an extra two months to market could make a tremendous difference, especially for life-saving drugs.
Click here to read the full article.