Biotech Values

[poorgradstudent]

Well, for scientific conferences, data are presented "as is". I think attendees realize that research is a dynamic and ongoing process. DNDN would have done well to present the data in a national forum, imo.

Also, I think the concept of tainting sensitive FDA discussions by presenting data is bunk. I talked to an FDA staffer a few years ago who came here to discuss clinical trials and drug development. She said that the FDA does not, in any way, discourage companies from presenting their clinical trial data in whole or in part at whatever forum they choose. What is discouraged are claims of efficacy and safety of a drug prior to FDA approval.

for example, the following is ok:

Our company's drug X showed median survival of 10 months versus competitor Y's median survival of 7 months. The following adverse events were reported...

Not ok:

Our drug showed efficacy because median survival was 10 months versus 5 months for placebo. The results also show that our drug is safe.