Yes, I am aware of that paper. I read it quite a while ago. The...

Yes, I am aware of that paper. I read it quite a while ago. The Richardson ref is for all for panels, the JAMA paper is ODAC only. Don't get too excited yet. The Richardson ref was specifically between the panel and the subsequent FDA decision. Not the panel and eventual approval. The JAMA paper looks at the panel vote and whether the drug was eventually approved for the indication. These are two very different endpoints. The Richardson reference does go on to say that many of the drugs initially denied approval were subsequently approved at a later date (it might have even given a specific number. I'm not going back to find it. My interest is satisfied). Neither paper is perfect, but, if you are going to look specifically at the odds of the panel to subsequent FDA decision, which is what we are interested here, you have to go with the Richardson paper, because that is what was looked at. What you (and I) can take heart-in is that MSB will eventually get approval for the drug, but it has a roughly 80% chance of approval the first go-around. You have to be very careful to ensure the paper accurately reflects the events you are after odds for.

This is the giveaway line in the JAMA paper, there is a high rate of concordance between advisory panel votes and the eventual FDA approval decision. If the paper were specifically looking at the first review, this would have been stated, because it is highly important to the way you interpret the information.

Redectane, which received an almost completely positive panel vote (16:0:1) and was never approved, was likely excluded from the JAMA analysis if the researchers classified the product as a diagnostic test. It is an injected imaging agent, not a therapeutic. Imaging agents are much more like drugs than diagnostic tests. I would have kept it in myself, but I think it is an issue for the investigator to decide.

By the way, I want MSB's cell therapy to be approved. My sentiment and position boxes are none and not-held because I am not making a call about the stock.