After some consideration, I've decided to bring the weekly PDUFA Pulse newsletter to a close.

When I started this project, the idea was straightforward: to provide independent, evidence-based analysis of upcoming FDA decisions, with an emphasis on probabilities, risks, and the distinction between what we know and what we think we know.

FDA catalysts are notoriously difficult to handicap. Clinical evidence, regulatory precedent, manufacturing issues, and the occasional complete surprise all play a part. My hope was that PDUFA Pulse could bring a little more clarity and discipline to that uncertainty.

Recent changes to the publishing platform made continuing in the current format less practical. I explored the possibility of making the newsletter reader-supported, but there wasn't enough interest to make that a sustainable path forward.

So rather than dilute the product or continue something I can't give the attention it deserves, I've decided to end the weekly publication.

To everyone who subscribed, opened an issue, shared a post, or followed along: thank you. I appreciate the time and attention you gave this experiment.

This may not be the last you hear from PDUFA Pulse. The intersection of biotech, regulation, and investing remains fascinating territory, and I'm considering where to take the project next.

But for now, this is the final newsletter.

Thanks for reading.

PDUFA Pulse