Koo...stream of conciouness posting coming, and as you know I'm new to biotech so you or anyone else please share your thoughts and correct any assumptions i make that are wrong.
The way I'm looking at things, FDA is one thing, Europe is another....and China is yet another. We have phase III status in Europe, but we're still waiting for....(from the June 22nd PR):
"....regulatory and protocol design update will be provided to the market post the approval of additional regulatory bodies and the launch of our planned Phase 3 clinical trial entitled BETonMACE."
Now....to get approval from "additional" regulatory bodies (FDA?) would not "orphan" status make that approval easier? I was trying to find a link to the April BNN interview because I believe DM made mention of the orphan status there as well....but I can't find an archived version of the video.
If they've scrapped plans to announce news on orphan status....then I think it would behoove them to notify the market. DM definitely mentioned it to investors with the Richmond Club, and I believe he did as well on BNN.
Thoughts, comments?