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Re: Amatuer17 post# 134095

Wednesday, 12/13/2017 11:00:12 AM

Wednesday, December 13, 2017 11:00:12 AM

Post# of 456867
Missling stated the Rett trial could start this year. For him to say that the IND had to be filed by November 30th, By looking at the charts, I suspect the IND was filed on Oct 19th and between then and now there has been a dialogue (most likely negative) due to the fact the trials did not start by November 19th. We had a 4 day spike in price from Oct 18 - Oct 24 (Wed thru Monday).when IND was submitted Most likely, the FDA responded in about a week seeking additional data and thus the $1 drop the next 3 days. Historically it's logical.

I gather Missling filed for both Rett and PD around Oct 19th and the next week the FDA axed the PD trial and thus the surprise move of PD to EU. It is a surprise moving to EU. No way was that planned when Missling said 3 trials to starting 2017. If PD was to go the EU route from day 1, the EU submission would have been done already. Now we learn in won't be until Q1 2018. Surely someone at HQ missed diagnosis the FDA allowing both Rett and PD to start concurrently.


Bottomline, Missling was able to file 2 of 3 trials and they could have both started this year. However, the FDA saw it differently and may only allow the Rett to start soon. Not both. Thus the surprise move to EU.

IMO, Missling was bold to predict 3 trials starting this year, most likely on input from Fadiran. In the end, imo, both Missling and Fadiran underestimated the FDA's actions.

It hindsight, the above scenario clearly points to what has transpired. Its perfectly clear in my mind. Lets hope the FDA allows us to move forward with the Rett trial soon, by soon I mean January 31st. If not by then, we won't see anything in 2018.
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