Since Complete Response Letters (CRLs) have become the fashion for CDER after August 11, I have tried to make it a point to see how different companies respond to the receipt of such a letter in public communications. As I wrote about in a previous posting on the issue, the nuance of language used in press releases about CRLs takes on added gravity.
In this letter, the FDA informed Gilead that the review of the company’s NDA has been completed. AN ODD STATEMENT NOT EXACTLY NEWSWORTHY.
The agency stated that they cannot approve the application in its current form and an additional clinical study will be required. DOES NOT YET SAY IF IT IS A SAFETY OR EFFICACY STUDY.
Gilead will continue its dialogue with the FDA to determine whether further analyses of existing data could lead to approval, or whether the company will need to conduct the additional study as stated in the letter. NOT SURE WHY THE FDA WOULD SAY NEW STUDIES IF THEY DIDN’T MEAN IT. THIS VAGUE SORT OF REFERENCE TO GETTING THE FDA TO CHANGE THE REQUEST SOUNDS LIKE AN APPEAL, BUT APPEALS ARE REALLY NEVER SUCCESSFUL AS ENCYSIVE HAS SHOWN, AND ONLY DELAY THE TIME UNTIL THE APPLICATION CAN BE REVIEWED PER FDA SPECIFICATIONS.
"Cystic fibrosis-related pseudomonal infections represent an area of significant and urgent unmet medical need. Our goal is to work with the FDA to deliver this product to the medical community and to people living with cystic fibrosis as quickly as possible," said John C. Martin, PhD, Chairman and CEO, Gilead Sciences. "The FDA has not raised any significant concerns A NEW STUDY SOUNDS SIGNIFICANT – CALLING IT OTHERWISE DOESN’T REALLY MAKE IT SO – regarding the safety profile of aztreonam lysine. THAT INDICATES THAT THE NEW STUDY IS NOT A SAFETY STUDY BUT AN EFFICACY STUDY. WHY NOT JUST SAY SO? Therefore, we will continue our expanded access program for those individuals who have limited treatment options and are at risk of disease progression."
I’ll continue to comment on the language used in Complete Response Letter Press Releases over the next several months.