HER2 Support Group Forums - View Single Post - Effort To Launch Breast Cancer Treatment Shows Complexities Of Drug Development

schoonder · 01-07-2011, 06:45 AM

IMO this article doesn't do a good job of addressing actual issue at hand. It talks about FDA's role of ensuring that drug is safe, but in T-DM1's case FDA for some absurd and surely with respect to targeted medicine outdated reason refused to even consider looking at the data. That decision send this program in a two-plus year tailspin.

01-07-2011, 06:45 AM	#2
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: Effort To Launch Breast Cancer Treatment Shows Complexities Of Drug Development IMO this article doesn't do a good job of addressing actual issue at hand. It talks about FDA's role of ensuring that drug is safe, but in T-DM1's case FDA for some absurd and surely with respect to targeted medicine outdated reason refused to even consider looking at the data. That decision send this program in a two-plus year tailspin.