An unprecedented move, a clear signal

A fast move, a quick profit! That's what happens to my Juno call. While I was very convinced that the Juno clinical hold would be lifted soon, I was only thinking about a 1-2 month time period. I have never thought about a lift in less than a week. This is really an unprecedented fast action from the FDA as far as I know. If you bought Juno a few days ago due to my call, I'm happy for you. But don't thank me; rather you should thank yourself for taking the contrarian action against the herd and more importantly your own luck!


Given this unprecedented quick action by the FDA, I'm thinking the FDA is sending a clear signal behind the decision. Believe or not, while the FDA will never tell in public what is the true reason deeply embedded in their action, you may decipher their thinking from their actions. I have done this in the past posted here as well. Four years ago in about 2 weeks prior to the FDA decision regarding the submission of ipilimumab (or more famously Yervoy), I openly predicted that Ipi would be approved. One important reason was from the FDA action to cancel the scheduled ODAC, a move very positive per my understanding. I got it right and made some quick money as well. So let me try to decipher again what the FDA is telling us. For me it is a very clear signal that the FDA is very interested in the CAR-T cell therapy and believes its clinical benefit very much. Think about it, if the FDA had a lot of doubt about its efficacy, would they simply lift the clinical hold without spending more time to carefully evaluate the fatal safety concern and the risk minimization measures JUNO is taking? Legally they have at least 30 days to review and can ask for an extension if needed. Such a quick action is nothing different from a statement that they believe in the clinical benefit from CAR-T and don't want a manageable safety concern to slow down the development process for it. If I can further make a bold prediction, I think the FDA will work with the companies for CAR-T therapies to make the development and submission/approval process as smooth as possible, since they want to see it commercialized as early as possible for the patients' benefit. Therefore I personally believe Juno has a good chance to still stay ahead of its competitors to be the first company to market the therapy, if they can manage to complete their studies as scheduled.


Now the question is what to do with the profitable positions. For those who got in below $30 and want to take the quick profit tomorrow, there is nothing wrong with that. After all, it all depends on one's initial aim: short-term trading vs long-term speculation. Personally I bought more when it came down further the next day. But I will hold my positions for long term since I very much believe the prospect of this technology and now given the clear signal from the FDA, I have more faith in it. Of course, we may still see some up and down days along the way, especially some unexpected surprises emerging. But as long as there is no evidence that may refute its clinical benefit, I will stay on the course to its end.