Missling needs to say the trial will be randomized, double blind, placebo controlled, multi country.
Is that what it will be? He probably has a clue but really can’t say otherwise. The fda hasn’t released any guidances yet. That is still under the old paradigm. Missling is not “suppose to know” what the new guidances will entail.
My guess is it will be different. It may be none of those adjectives.
Along these lines, I think Dr. M. went with plan B. Between FDA confusion new protocols, BP resistance and long list of TBD...The guy just went with what he knew, so what it is not FDA direct , maybe he saw that as a ++.
JJ my guess is that Biogen IS still out there! Upcoming news should shine the light on a possible partnership after the new trial design is accepted by FDA for MS. Perhaps Biogen is handling that end of it.
I also noticed that Dr. Missling keeps mentioning that Rett Syndrome received "orphan" drug designation. This has to play into the mix of "acceleration" somewhere. My guess is the RWE feedback from patients and caregivers due to the 21rst CCA.
Over all not quite the present under the X-mass tree this year I was hoping for but Im not letting the doubting Thomas's around here cloud my vision and steal my shares.