MSB to dispute FDA finding in Type A meeting, page-96

The regulator has made a decision. IMO it is unlikely they didn’t think about it or look at the evidence. They obviously had concerns about the product. This was clear previously as well. Although there is always a chance, unlikely the decision will be reversed. Some hope for provisional approval with undertaking that a further study is done after. More likely the further study will be required first. (all IMO)

No chance Scotty from marketing will have any sway at all. It is not a political process despite many posts believing this is the reason for non approval. A good conspiracy about why the umpire cheated us may make you feel better, but won’t change the facts.

Sad for such a promising Australian company. Will likely take a fair bit of coin and time to firm up the evidence. Hold on and see how it goes I suppose.