Replies to post #183612 on Biotech Values

[iwfal]

I like their straightforwardness and honesty. I am wondering whether I give them too much benefit of the doubt...

I too find their openness very encouraging. And they are clearly working hard to acknowledge issues and then fix them. Much better than the vast majority of biotechs IMO. And their science and general research and approach appear very good. But running clinical trials is a specialized skill (and scars are generally required). E.g. It requires a certain amount of cold bloodedness to ensure, for instance, consistent behavior - but the alternative is extra risk that not only will the drug fail unnecessarily (and be unavailable to patients), but that your placebo patients will have suffered for naught.

As for this particular error. Agree it *probably* is survivable. But, as with anything that allows inconsistent behavior, it adds risk and reduces power. (There is a good reasons some trial sites are sought after and others avoided - one is that the good ones are predictable at following protocol.)

Although given the previous trial I find it hard to believe that Gev wont work in Bechets.

The problem is that even a good drug can be killed by a poor trial. Again I don't think this a huge risk. But it was probably unnecessary even if it meant using a totally different protocol.

BTW - an interesting topic would be how often the FDA tries to require a protocol that is substantially riskier/worse than what the average MD does or would do.