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Jonjones325

12/11/17 2:51 PM

#133802 RE: Jonjones325 #133800

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.

New paradigm. Where is it?
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nidan7500

12/11/17 3:07 PM

#133805 RE: Jonjones325 #133800

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 ++.
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gburgin

12/11/17 3:18 PM

#133809 RE: Jonjones325 #133800

It'll be interesting to hear what kind of questions (and questioners) are entertained at the end of this call.
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tredenwater2

12/11/17 5:21 PM

#133850 RE: Jonjones325 #133800



Biogen? U still out there?




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.

A few more months is ok with me.

Tred