Annnddd….I might add there is value in patience and navigating the prisms of the halls of the Fda. 1) data continues to pour out, like the brain shrinkage reduction. 2) the Fda is a changin, 3) every week/month another Alzh company fails or another mab gets disqualified by some governing agency in the world for reimbursement. A poker analogy would be that its kind of like sitting back and letting the chip bully take everyone else out as you wait for the best possible hand only in this case, we wont be second when we get done playing our hand.
Our drug will have the data to support mass adoption coupled with the safety and ability to reach patients globally in every walk of life! If Amazon can reach you, you are eligible! We have one shot, if we rush it and the Fda or EMA kick it back from a technicality causing a delay Dr Missling will get grief. If he takes his time to be thorough (German heritage shining through) he also gets grief. The latter though if done properly WILL be successful in achieving approval imo.
Cheers