Biotech Values

[jq1234]

Roche had a pre-submission meeting with the FDA. I can't imagine this issue didn't come up in the meetings.

I support FDA initiative to make key communication between FDA and sponsor public, CRL, RTF, etc. I just want to point out, you only hear sponsor company's interpretation of FDA communication, you don't know what else are in there. Based on personal experiences, FDA's CRL and RTF are quite long, the public only see the parsing of certain items from those communication. Current regulation doesn't allow FDA to make public comment. I think this contributes to the sentiment everything is FDA's fault when a drug doesn't get approved.