if i remember correctly the crv has some points about cost and time of eventually new trials needed;
can wmgi use this fda letter as an excuse to not pay the crv and use Augment in the futere if they get approval after new trials and costs (maybe less onerous of the crv)?
The CRV's are good for 6 years from time of closing of the merger so about March of 2019. I still believe the milestone payment will be made if they continue Augment Injectable and the regular Augment as it is still Augment just liquid form. That trial could take another year to finish and then approval can filed thereafter. It is in Wrights best interest to continue Augment trials and try to appeal regular and get approval as its is a large market and much further along then the other Augment line of potential products. Also, they want to keep the Biomementic brains aboard and motivated to help see them through the technical aspects of any trials, etc..
WMGI should start buying up the CRVs aggressively today and get as many as they can below $1 thereby reducing potential milestone payments in the future IMO. Never did I think they would not approval Augment or I wouldn't of bet so much on it. It is frustrating and aggravating but at least they have final clarity on the new rules the FDA has made since the 'game' started! They can still win an appeal for regular Augment but from what I read they have just 30 days to appeal decision or then they can't after that!