BiQ: Milestone Therapeutics Receives a CRL for CARDAMYST (MIST)

Milestone Therapeutics (MIST) received a Complete Response Letter (CRL) for CARDAMYST related to what appear to be minor Chemistry, Manufacturing, and Controls (CMC) issues, causing the stock to sell off by over 60%. Obviously, this is very disappointing news for the company and for MIST shareholders.

It's very tempting to think we can predict inherently unpredictable events, and I've seen numerous posts on Twitter and elsewhere by people on both sides of the debate claiming credit for knowing what was going to happen. The truth is, nobody could have predicted a CMC issue; all anyone could have done was prepare for the possibility and manage the risk. The risks here were evident: 1) a binary outcome and 2) a delayed launch (as per management's earlier comments). As for the rest, as they say, only hindsight is 20/20.

This is the trading update I shared with BiQ Premium members yesterday in the BiQ chat forum. I'm not any smarter than anyone else, and I definitely got lucky with my timing--and I still took a hit this morning with the CRL. However, the key point is that by carefully assessing the risks and managing exposure, especially with highly binary events, we can at least mitigate the damage when faced with outcomes that are impossible to predict.

It's important to remember that biotech investing doesn't have to be a competition. I choose to look at it as a team sport. For MIST shareholders, it's understandable to feel disappointed and perhaps even powerless in the face of such unanticipated bad news. But we're all in the same boat and trying to paddle in the same direction, and we should expect some chop along the way. What's important is that we help each other up, dry off, and keep rowing forward.

As for MIST, what's most important now is what comes next.