A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
With added, positive Phase III breast cancer data from a trial called EMILIA for the antibody-drug conjugate T-DM1, Roche AG subsidiary Genentech and partner ImmunoGen uplifted — but didn’t overly surprise — investors, who are waiting to see whether the first label permits front-line use in metastatic disease. BioWorld