Biotech Values

[walldiver]

I would imagine that the time DNDN initiates a compassionate use program would be the period after positive interim 9902B results and prior to FDA approval (or between positive final results and approval). I don't think the company wants to run a concurrent Phase 3 trial and compassionate use program.

As for the ad, I provided a very small amount of advice for the organizers, but that was it. The one realistic result of the ad that I'd like to see would be for someone to investigate Howard Scher's obvious conflict of interest issues. When you chair the scientific advisory board of a competitor that is showering money on your employer, you shouldn't be a voting member of an FDA advisory committee that is reviewing a product that would compete with your benefactor's...and when the panel vote goes against you, you shouldn't be able to influence the final decision-making process with disingenuous letters to the FDA that you know will be leaked.