Oh, I think you are reading too much into a couple of lines in...

Oh, I think you are reading too much into a couple of lines in an AR, without the knowledge to know what you are reading. They will be doing what any company has to do when they make extensive changes to the manufacturing of a complex therapy. That is, show that it is the same as the one they will be replacing. They are not saying that the product from the bioreactors has to go through pre-clinical and, then, a full slate of clinical trials before they can swap it in for a marketed product. They just have to show that it is functionally the same. You have to do this for any drug or biologic if you change the way it is manufactured. Some pre-clinical testing and some DNA sequencing would have been enough I would have thought. Due to the complexity of cellular therapies, the regulators may ask to see how it performs in the human body. Hence, the line about clinical trials in the AR. I can tell you one thing for sure, if MSB gets a positive readout from the ARDS trial, Novartis will make sure MSB has all the money and external expertise they need to get high volume manufacturing up and running as quickly as anybody could.