Welcome to the RVX board SunClub77 

Please take a minute to review the Welcome page that BearDownAZ has put together for new and experienced posters alike in the Link Library that you can find on the left side of this page. Bear has been so busy adding to the Link Library lately that you will now find that Welcome Note on page 6 of that Library. You can find all kinds of information in there including links to articles, posts, written presentations that were made at AGM's and other presentations and some outstanding comments made by some posters that were above and beyond what is normally posted. The info in the Link Library is not only about posts that members have made but about the science we are in and corporate events as well.

I don't know how you have concluded that it was clear that pursuing an NDA at current stage was not an appropriate move at this time. We have heard nothing from the company about this at all. DM's comment about it taking 90 - 120 days post CTAD to apply for breakthrough status was very appropriate in my mind. The company is still sorting through and compiling hoards of information gleaned from the BETonMACE trial. It is likely that they will need to extract some specific information from the trial to support any application that may be filed and they are still in the process of processing that info. The only thing that DM said at the AGM about the FDA meeting  is that they wouldn't say anything at all about what was said in that meeting, until after they received a letter from the FDA confirming what they had talked about, and that the letter would be received about 30 days after that meeting. DM did not say that they would be announcing what the content of that meeting was either when he made that comment at the AGM, at least not from what I heard.

Please take a minute when rating other posts to either Recommend and or Rate those posts and posters. If you see a post that you feel would be beneficial for others to read please click on the Recommend button on the bottom right side of that post while you are signed in. It is also a curtesy to click on the Recommend button to acknowledge the time that someone took to answer a question you may have asked. You can also Rate a post by clicking on one of the 5 blue stars at the top center of someone’s post while logged in. The rating system is on a 1 to 5-star basis, 5 for great job you have put some time, effort and thought into that, and 1 for maybe you should go back to the drawing board. Of course, there is always the other stars in the middle that work as well.
We look forward to having you participate on the RVX board in the future. 

tada