Its my opinion (and my guts too,....in between beers)that we are in for some FDA news. Why else would Christine M. Kapiak be attending? I remember when she got her promotion to V.P. and it was soon after that the (2)orphan drug designations came out for A 2-73 and (1) 3-71. Its been quiet for some time now and I get the sneaky suspicion that with Ariana coming on board that Dr. Missling may have indeed found the "mined" data he needed to support the monotherapy patients response. Correct me if I'm wrong but wasn't the painter, pianoist, and golfer's anecdotal evidence all at or around the "9 month" mark when they were interviewed? It was there for the FDA and the good Dr. to see,..... they just couldn't share it or didn't have anything to support it because they were all in a 7 person subgroup. I'm going out on a limb and saying that we get:
1)41 week data and possibly 52 week data with Ariana's involvement.
2)some form of FDA Fasttrack or accelerated approval through or in combination with a grant from the 2017 Cures ACT for a Phase 2/3 for ALZ.
3)Parkinsons news before or right after the CTAD conference.
4)Possibly a funding mechanism for PTSD and Dementia also from the Cures Act.(providing the cures act is funded)
IF Ariana's FDA approved algorithm is fast in finding bio markers, I'm wondering just how far have they caught up in their analyzing of data as some of the patients are now entering 2 years on this drug. You never know, that subgroup the SUPER 7 may be running marathons in the "downunder"!
Goodday Mate!
Tred
