So what you're effectively saying is that if there's no announcement by March 1 everyone should sell.
I aim to communicate as clearly as possible. While I'm aware that I sometimes fail to meet that goal, I’m frankly puzzled by your reading of my post. Did anyone else interpret what I said this way???
In answer to your question about whether the FDA has ever extended the PDUFA date, I would have thought that most people here would have already been aware that that can happen, for various reasons. For example, the FDA might request more data analysis and set the PDUFA date back by a few months. And during Covid there were numerous PDUFA extensions due to FDA’s inability to access manufacturing sites for inspection.
As I stated
The PDUFA is a performance goal rather than a guarantee. That said, the FDA does a pretty good job of meeting its performance goals. Last year, 100% of priority review designated NMEs (i.e. novel drugs) were acted on by their assigned PDUFA dates.
With respect to your comments on "cherrypicking", the reason I focused on early FDA approvals was because I thought there would be a fair number of people here who were not aware that the FDA can sometimes approve well before the PDUFA date. Btw, I’d be interested for people here to let me know if that thinking was correct.
How others use this knowledge is up to them. I am aware that there are investors who make buying and selling decisions based around PDUFA dates – some choose to get in in the lead up to the decision, punting on a positive decision and hoping for post-decision gains. Others aim to ride the gains in the period leading up to the decision and exit just before the PDUFA date. I would simply observe that any early decision (which I have shown is possible, not probable) could certainly derail the plans of investors in the second group.
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