Biotech Values

[iwfal]

surely Gottleib and the FDA are aware of this question of "tissue agnosticism." So why are they proceeding down this road?

Well, obviously I don't know. But there are plenty of reasonable and pragmatic issues to discuss and set down in guidance: assays allowed, linking of the assays to the treatment, what level of consistency among tissue types is necessary, ... .

At this point I am willing to give Gottlieb the benefit of the doubt since in general he seems to have made interesting and out of the box choices without significantly sacrificing knowledge of safety vs efficacy. (I do wish that in his verve to enable cost savings he would crack down on devices since there is undoubtedly a large amount of money wasted on useless, or worse, harmful devices. But that is probably a bridge too far.)