George 1972, you wrote "Mark Diamond is a very credible CEO. And...

George 1972, you wrote "Mark Diamond is a very credible CEO. And quite conservative so read his quote at the bottom of the announcement and I would recommend everyone to do so again." Quite a number of other posters have also noted and commented on those final sentences.

" ....The feedback will be reviewed by our internal team and incorporated into our global clinical development and commercialisation plans" and "Based on the guidance meeting with the FDA, together with prior feedback from EMA and world leading DMD experts, we are reassured that the data from our Phase II study is encouraging and that it is reasonable and appropriate to advance the program towards potentially pivotal clinical studies. It is our goal to bring this medication to as many DMD patients worldwide as possible”

Having read those sentences quite a few times, I think they mean that the company has decided that its clinical case is valid and the company plan has been amended to concentrate on that, rather than on both clinical development and commercialisation at the same time. In simpler terms, their priority is amended to prove their medication is successful, get it approved for sale worldwide to all those who are afflicted with the disease as quickly as possible - and the commercial returns will be progressed differently.

In order to do that I would have a swing for the fences and think they may get an arrangement with CSL, another trial organised in Australia which would be independent of EMU/FDA views, and something going involving the World Health Organisation who I think have an over-riding role to get needed medicines supplied to all countries in need of them, and deal with other commercial issues separately, or the EMU/FDA may choose to go along with what the company means by "advance the program".