Replies to post #33531 on Biotech Values

[AlpineBV_Miller]

Neurocrine food study...

When I see stuff like this, I have to wonder where the error lies.

Did the FDA tell the developers off and on over the past few years they wanted PF/PD studies with mutiple food types and nobody listened?

Or did the FDA simply create this one out of whole cloth: "Surprise, new thing we want. Sorry it hoses your clinical development plan, but that's not our problem."

Finally, does this ring false to anyone else? PFE punts the drug for want of a food-based PK/PD trial? Very strange.