Ann: Trading Halt, page-602

"I don’t think it is on the grounds of efficacy or safety. Rather on manufacturing."

Unfortunately, that was my gut conclusion within about 10 seconds of reading the wording of TH. I've spent the best part of yesterday trying to convince myself of any other possible conclusion but the sequence of events and knowing a little about the internal machinations of FDA leads me to believe that is my 80% likelihood.

The only other possibility that has been mentioned, but I also have no precedence to my knowledge, is that they have politely told them on action date they are running behind and will complete by end of week, given it is a priority review. Another outside possibility is that due to the complex conditions, maybe around Phase 4 trials that will be specified on the approval latter, if anything is different than what was agreed/discussed between MSB and FDA, they may want to seek clarification/correction before making an announcement.

Otherwise, it makes complete sense that if there are some Form 483's from the FDA inspection at Lonza, that Lonza and MSB will be furiously be working with their regulatory teams and consultants to identify the corrective actions and timeframes to correct. As an investor, I want to understand how long those issues will take to resolve when they make their announcement on Monday. They have to apply due diligence in providing investors with those timeframes and that takes time. And, no, they are not obliged to provide the FDA response as soon as they have it, as some have put forward as part of continuous disclosure. Part of continuous disclosure requirements is that the market is fully informed when the shares are trading. To be fully informed, we need to understand if the delay will be 3 months or 12 months. So if they need to spend the weekend working that out, that is the best protection of shareholder interests they can do at this time.

Obviously, I hope I am 100% wrong and am ridiculed on Monday for my "paranoia". Very happy to cop that.