this is a good post, but a negative outcome/significant delay, or outright rejection is not priced in. AFFY can go a lot lower if rejected and Takeda bails. As AF said, the data look adequate, or similar. The FDA review on Monday will probably look negative, it usually does, so there may be a change to buy lower on Monday morning for those interested. FDA is always a risk, but the efficacy is similar and safety as good in the intended patient population with the portneital for pricing and convenience improvement.
You know AF is a short shill. He outlines the risks quite well. But I would like to know more about non dialisis patients, there could be an easy explanation for the higher cardiac events. Could be a bad interaction with something else they are on. also by AF logic avastin should be raising fda concerns because of the adverse side effects in breast cancer patients. As you know they treat many other indications
let's hope AFFY/Takeda have dug deep into the data and are prepared to answer FDA's questions and that we get a qualified and fair panel without too many stats tools. The stats people are always negative.
Since there is not a large short position, I doubt AF has a short interest in AFFY. He is always against anything that has even the appearance of sub group analysis, which is a big stretch here.