Biotech Values

[poorgradstudent]

SRPT:

At this instant, yes. But in an AdCom I'll bet 10:1 other items pop up as big as this. E.g. :

Agree with you. I think the dystrophin analyses are useful for the FDA because they're a clearly visible, non-political / non-emotional item to spotlight. There are a myriad of other issues, like the ones you mention, that are probably a bit too inside-baseball for a public PR.

AF is saying the FDA shoulders some blame because their leadership were out getting photo ops and such with the advocates. Therefore, this release is a way of them covering their butts. I think that's a bit over the top, and reflective of how AF got emotionally invested in this story. It seems to me just as likely that the FDA thought their guidance of SRPT was going well, and that they expected the company to act on their guidance to assure smooth sailing. But, as you note, SRPT doesn't seem to have been the most gracious recipient of guidance.

I should put out that I'm not one of these anti-FDA people who thinks the agency is capricious. I also think it is fair to say that SRPT was more interested in squeezing more from what they already had rather than accrue new data to fortify their position.