I like you don't know why the BTD request was deni

Quote:

---

I like you don't know why the BTD request was denied. The idea that there was a dosage confusion would be consistent with our problems with the FDA, though I would claim the FDA must bear much of the burden for those confusions.

---

It isn't about the dosage. The FDA likes comparing dosages because a bigger benefit at a higher dosage would show the consistency of the benefit. For BTD they may be only looking at mOS and not mPFS because they think it's what's important although the much higher mPFS supports that mOS will end up much longer than 12.1 months.